HELENE Biomedical's Stem Cell Business Strategies Assignment Examples

Chapter 1: Introduction

1.1. Introduction

The group of medical businesses particularly HELENE Biomedical Group which has taken initiatives in stem cell treatment and this adversely evolved in the field of regenerative medicine. This investigation has set the motifs where this type of business field can analyze how this can be improved within the global market. This sector can embrace its promises with the help of therapies that can repair the damaged tissues within the patient's body. So analyzing the business impact of this group of regenerative medicine can help in the contribution of the valuable perceptions to the commercialization, financial sustainability, and ethical guidelines within stem cell therapies. This study has successfully represented the suitable aim and objectives that need to be achieved to get the desired outcomes and helps in the capturing of market share. The questions of the research are also represented which are analysed through the investigation. The research significance helps to understand the importance of the study in this type of field.

The investigation into HELENE Biomedical Group's stem cell therapy business model highlights innovative strategies for market commercialization and patient outcomes. Native Assignment Help provides expert support for crafting high-quality academic papers, ensuring your assignment help needs are met with precision and clarity. This study underscores the importance of ethical guidelines and financial sustainability, which Native Assignment Help can assist in exploring through tailored academic solutions.

1.2. Background of the study

The sector of regenerative medicine specifically stem cell therapy has gathered prominent attention for the fulfillment of the requirement in the healthcare industries. The background of the study helps to understand how the idea of the study has regenerated to do the investigation. So the importance of stem cell therapy requires to be known first and this investigation has also focused on the financial stabilities of regenerative medicine within this group of medicine. Stem cells have the potential to improve the different types of cells which can able to make a revolution in the treatment of critical conditions specifically in the cases of neurological problems and cardiac problems (Armstrong et al. 2020). The HELENE Biomedical Group has evolved its perspectives which has set its objectives to improve its treatment facilities for delivering effective stem cell treatments. In recent days the idea of regenerative medicine has grown exponentially so this requires to know that how this company can direct their development of the patients' outcomes with the market commercialization. So this study has focused on the ethical considerations that need to be taken by the company at the time of application of those therapies. Financial and strategic dimensions are also crucial in the contribution to the healthcare industry.

1.3. Research Aim

The main aim of this study is to evaluate the business approaches, financial sustainability, and ethical guidelines of the HELENE Biomedical Group in the industry of regenerative medicine. This study has taken the initiative to achieve market commercialization in the global market with promising outcomes among the patients.

1.4 Research Objectives

• To investigate the business model of HELENE Biomedical Group and its position in the global market.
• To evaluate the financial approaches and sustainabilities in the time of operations within the group management.
• To analyze the several challenges with the various strategies in the time of stem cell treatment.
• To examine the ethical guidelines in the sourcing and the application of stem cell treatments among patients.
• To measure the influence of the treatment by HELENE Biomedical Group in getting desired outcomes.

1.5 Research Questions

1. What is the approached business model and strategies of market positioning that need to be achieved by HELENE Biomedical Group?
2. How is this group of medicines able to keep financial sustainability in the global market?
3. What types of challenges are experienced by HELENE Biomedical Group and how can those barriers be improved?
4. What ethical guidelines are engaged in the treatments of stem cells and how are they accomplished?
5. What types of influence do treatments by HELENE Biomedical Group observe among the patients?

1.6 Research Rationale

This investigation has invested in a sphere of medicine where innovative ideas of humans can meet business opportunities. The investigation of regenerative medicine has discussed about the HELENE BioMedical Group which has initiated stem cell treatments in their facilities. The stem cell treatment stage that the HELENE BioMedical Group serves has successfully outlined an unusually high-impact intersection between health innovation and profitmaking. In this way, it can achieve its objective of keeping its position in the market (Beheshtizadeh et al. 2022). With the regenerative medicine market expanding, it is becoming more prominent that stem cell therapies can disrupt and reconfigure how healthcare has been done. This special type of cell is being targeted in new therapies for diseases that have no cure today, including spinal cord injuries, neurodegenerative disorders, and other types of cancer. So the impact of this type of therapy is very remarkable. This means it is important to examine and understand HSBC within this rapidly growing industry where the potential exists. The research of this company, and the regenerative medicine business in general with HELENE BioMedical Group as its primary focus has several reasons. The first reason is the Increasing Demand for Curative (vs Symptomatic) Solutions in Advanced Medical Treatments Regenerative medicine, and stem cell therapy fit perfectly within this demand by repairing or replacing damaged tissues and organs. The second raeson is, that the regulatory climate is changing for stem cell treatments as more countries recognize and approve these therapies. It is also significant as it helps to know how the HELENE BioMedical Group moves through this regulatory environment which gives the indications as to Elite how the experts are applying best practices and strategies for compliance, and market entry (Goddard, N.V. and Waterhouse, 2020). It has focused on significant financial improvements for stem cell treatments. There are many complications in the assessment of this type of therapy like the cost for advancement of this type of treatment so this can be considered as the barrier. So this company has effectively managed several opportunities where it can offer an effective deal to reduce its costs with effective productivity. Evaluating the business model for this company there are many effective strategies that can be known with the strategies of market positioning so it can effectively contribute the commercial achievement in the global market.

1.7 Research Significance

Investigating the business aspects of this medical group in the sector of regenerative medicine can show a remarkable position in the field of medicine for many reasons. The reasons are enlisted in this to get a better understanding of where it helps in comprehending the importance of the business in getting suitable outcomes (Banda et al. 2021). The first reason is that it can contribute to a wide understanding of creative medical treatments that would be effectively commercialized. This investigation is prominent in the industry of healthcare which has shifted to the adopted and regenerative medicine like the companies of HELENE Biomedical Group. So this group of companies can play a significant role in determining prospective medical paradigms. There are many insights that can be acquired from the investigation which can apprise other initiatives and stakeholders in the healthcare industry to encourage the efficient and building of productive business practices. Research significance also helps to understand how much the study is relevant to the recent environment and how this investigation is capable of its effects. The main significance is its economic impact. The market of regenerative medicine is expected to reach significant growth in the upcoming years which is controlled by technological improvements and helps in the enhancement of the patient's demands for the employment of novel therapies. With the analysis of the HELENE Biomedical Group’s initiatives to capture the share of the market, it can manage the R&D investments and direct the various barriers. So this investigation can offer a blueprint that can show the financial sustainability with productivity in this type of industry. So this is also significant for several policymakers, and depositors who help to observe the facilitation of the potentiality of the market (Master et al.2020). The ethical considerations with the several regulations within stem cell therapies are evaluated as the most significant areas to concentrate on. So this investigation is helpful as it has helped to enlighten how this medical group can recognize ethical issues including application and sourcing of stem cells. So this understanding is very crucial as it helps to maintain public belief and progress the approval of stem cell treatments. Lastly, it is also significant for health outcomes. With the comprehension of business mechanisms, this study of stem cell treatment within this company can offer better policies to develop health outcomes.

1.8 Research Framework

Figure 1: Research Framework

1.9 Conclusion

In conclusion, it can be concluded that the business of regenerative medicine is significant in the healthcare industry and this type of business has significantly emerged in recent days. So this investigation is crucial in advanced healthcare settings. This medicine group of HELENE Biomedical Group has evaluated its stem cell treatment where it can achieve the desired outcomes in the conditions of critical patients who have suffered cardiac diseases or neurological disorders. This study has successfully presented the aim and objectives of the investigation which requires to be accomplished. The research questions are represented in this chapter where this study has focused on financial sustainability and holding the position in the global market. The rationale of the research has been evaluated with the significance of the investigation which has helped to comprehend how much this investigation is valuable in recent times. The proper framework of the investigation has also been represented in this investigation where it has represented how the whole study can be proceeded in the future and how it will be able to achieve the desired outcomes.

Chapter 2: Literature Review

2.1. Introduction

The chapter on literature review has helped to focus on the existing journals which were already been covered by several authors and this can help to enhance the knowledge of this relevant subject. The empirical studies can represent several studies to gather relevant information based on the business aspects of regenerative medicine and how this concept is becoming popular in the medical field. This chapter has also represented the relevant theories with the models to display how those theories can be relevant to this investigation. The gap between those selective studies also has been represented in this study to understand which aspects of the study will need to be improved in future studies. The conceptual framework also has been emphasized here to understand the variables.

2.2. Empirical Study

Development and Barriers in Regenerative Medicine Interpretation

Figure 2: Timeline of the recent history of regenerative medicine

According to, Jacques, and Suuronen, 2020, the authors have stated that Regenerative medicine, or RM has been one of the most talked-about issues in technology for the past thirty years, yet the field's results at the bedside have been largely underwhelming. This could have to do with the disruptive character of these new technologies and their novelty, which has made translation more difficult. As a result, the authors have also observed how the translational strategy has evolved in the context of the RM discipline. They specifically inspect how the search for such innovative regenerative therapies has altered the way professionals attempt to integrate their concepts into clinical settings, and then they identify the issues that must be resolved or strengthened before these therapies are eventually included in the accepted standard of care. Changes in the business community should also be discussed in this study because, as previously mentioned, one of the biggest challenges facing RM is and will continue to be manufacturing and marketing, for which the originality of the area is to blame. It is important to recognize that there has been a shift in company strategy even though the majority of the issues still exist (Jacques, and Suuronen, 2020). Small and medium-sized businesses or academic research institutions have historically conducted RM research. In light of this, the business models employed by different types of companies in the health sector differ. Biotech businesses are the ones that use the royalty model the most. So this study has described how this concept of regenerative medicine can be used in business strategies.

Global Legal Frameworks and Supervisory Approaches for Regenerative Medicines

According to Qiu et al. 2020, This paper reviewed the legal frameworks of regenerative medicines from nine countries including the United States, Japan, South Korea, Australia, Canada, New Zealand, Singapore, China, India, and the European Union. It was to determine the paths of regulation of approved RMs and to draw attention to special programs fast-track for marketing authorization purposes. Therefore, by using the general internet search and the analysis of the articles in Medline and Embase databases, the study offered an extensive description of the international regulation of RMs from official regulatory authorities’ websites. Research showed that there are particular RM legislation or frameworks in the EU, United States of America, Japan, South Korea, and Australia. A risk-based approach that excluded eligible RMs from some of the regulations on MA was recorded in the EU and six countries. Every investigated region has followed the strategy of setting up programs for fast-track review or approval for the RM market. Collectively, 55 RMs have been granted MA across the studied regions; 23 have claimed Priority Medicine status, 32 have been approved as Regenerative Medicine Advanced Therapy, and 11 have claimed Japan’s SAKIGAKE status. Finally, the study found that although regulators have developed active policies to enhance the RM approval process, there are still major issues because of the differences in international regulations. These findings stress the calls for the need to work towards the convergence of the regulation of regenerative medicines across the world to ease the approval processes. It is expected that regenerative medicine will take over the century’s health agenda through the provision of new treatments for patients suffering from various diseases and disability. Due to the scientific and reasonable approaches to the regulation of innovative technologies, it has become possible to establish new forms of care that had been previously unthought. This review intends to describe the necessary tools and the necessary conditions that would help in the clinical preparedness of regenerative care.

Planning of Reasonable Regenerative Solutions

According to Yamada, Behfar, and Terzic, 2021, the authors have investigated by emphasizing the extension of the design, manufacturing, and validation of affordable regenerative solutions with the aim of extending these benefits to everyone. The combined endeavor is being made to democratize the promise of health by the wise adoption of regeneration rights. So the authors have designed reasonable solutions that assure the maximum benefits at the time of application (Yamada, Behfar, and Terzic, 2021). The authors have realized the main components of this study to get maximum benefits with the help of regenerative technologies. The authors have to evaluate how this concept can regulate their business policies in the global market. This has also highlighted the regulatory pathways and medicines the type which is required for the approval of regenerative medicines.

Influence of Regenerative therapies on Business Approaches

According to Hahn, and Tampe, 2021, the authors have said the impacts of regenerative medicines in the business. Growing societal matters and increasing environmental deprivation emphasize the necessity of reevaluating the manner that which business is now conducted. Social-ecological systems are necessary for human and commercial activity, however, these systems are frequently taken for granted. The consequence of sustainability considerations for business strategy and organization has been recognized by the existing research on business sustainability. However, prevalent interpretations of corporate sustainability continue to center upon the company and its economic case, to identify tactics that convert less damaging practices for society and the environment into advantages over competitors. Few academics have taken a systems approach to deduce business techniques using the logical structure of social-ecological systems, moving beyond such an economic logic. Our major contribution is the development of the “restore-preserve-enhance broad adoption” for regeneration company approaches, which represents a range of regeneration strategies (Hahn, and Tampe, 2021. These tactics come from two primary ideas and associated standards for a flexible managerial approach to regeneration and a systems-based aspiration level. The authors have essentially moved the emphasis from an economic understanding to a technological logic by doing this. Crucially, we provide organizations with specific tactics to foster life-sustaining circumstances in social-ecological systems.

Biomedical Applications by 3D Printing Technologies

Figure 3: Integration of conventional 3D printing, and imaging for regenerative medicine

According to Ramadan, and Zourob, 2021, The authors have focused on one of the main forces behind the current paradigm shift in the manufacturing processes across several industrial fields is 3D printing technology. Through the use of living cells encapsulated in particular natural or synthetic biomaterials such as hydrogels like bio-inks, the incorporation of 3D printing into tissue engineering is opening up new avenues for the development of creative solutions for important biomedical and healthcare problems. In this article, the authors have summarized the state of the art in 3D bio-printing technology based on findings and accomplishments in many applications and addressed the potential and limitations of this technology. Through these approaches, bio-printing technology is progressing autonomously; the true problem lies in integrating various procedures into an industrially scalable technology. However, bio-printing has a lot of promise to compete with conventional tissue engineering methods and can provide answers to many current challenges in technology.

Market potential and Business Aspects of regenerative therapies

Figure 4: The main principles in the process of commercialization in regenerative medicine

According to Beheshtizadeh et al. 2022, the authors have focused on the utilization of regenerative medicine. So it has been stated that regenerative medicine aims to restore, redevelop, or recreate damaged tissues and organs to restore function. Despite being a relatively new subject, regenerative medicine is creating progress toward its goals because of the efforts of numerous varied research groups. All efforts in this field must first undergo clinical trials, in vitro, in live animals, and in computational studies, which are essential to move these methods from the research laboratory to the therapy. Even so, only a small number of regenerative medicine strategies have made it into the market because of the high requirements for incorporating a variety of strategies, funding sources, and boundaries. This review identifies the business aspects of regenerative medicine, which includes several important topics such as methods, regulatory issues, immunological considerations, and progress or lack thereof in this field. Along with commercially accessible cell and gene therapy items, the review also covers engineered tissues that are accessible for purchase, such as allografts, synthetic replacements, and 3D bio-printing inks (Beheshtizadeh et al. 2022). Products related to regenerative medicine have a desirable and expanding market. Based on current studies, the global market for regenerative medicine was expected to be worth US$ 7.6 billion at the time in the year of 2020. The market is projected to increase at an annualized rate of growth or CAGR of 16.1% from the following year, 2020 to the year 2027, reaching about US$ 23.7 billion.

Barriers related to stem cell therapies

Figure 5: The market of stem cell therapy

According to Bahari, Mokhtari, and Yeganeh, 2023, the authors have described the stem cell therapy and how can this used for commercial purposes. Stem cell therapy is also ranked as the most popular type of treatment within the framework of regenerative medicine, and the market for this therapy has grown rapidly in recent years. This paper recapitulates the current overview of the stem cell therapy market with a focus on the factors influencing its growth. Studies incorporated a systematized search of the scholarly databases for articles and analysis of the credible sources of financial information on the market. Based on the research conducted for this report, the present global stem cell market size is computed to be USD 297 million in 2022; moreover, it is projected to expand at a CAGR of 16%. About 8% for the period of 2022 to 2027. The growth factors for it include better clinical trials, funds availability for stem cell research, technology, and facility development in cell therapy, and the demand for regenerative medicine. At the same time, the market has the following threats such as ethical factors, regulatory issues, and the prohibitively expensive stem cell treatments and goods (Bahari, Mokhtari, and Yeganeh, 2023). Thus, to contribute to market development, the regulatory process for clinical use should be simplified according to the findings of the study. Also, there is a problem of an increase in the use of unproven stem cell treatments, which risks both the patients and the market. Sorting these problems out is significant for the future development of the stem cell therapy market.

Developments and barriers in regenerative medicine and aspects of tissue engineering

According to Han et al. 2020, the authors have successfully outlined the establishment of regenerative therapies in the past few years. The study has focused on the motive for which reason regenerative therapies are becoming popular day by day. Researching innovative methods to enhance the medical treatment of the sick and elderly population is a global challenge. “Tissue engineering for regeneration and regenerative therapy or TERM” is one approach that has steadily developed toward this end. In a promising method to address patients' demands in the future. The number of study participants, publications, clinical studies, and translational products has risen significantly, indicating that TERM has gathered considerable interest in Asia recently. By displaying some of the significant advancements in the area and highlighting the significant accomplishments of exemplary research groups, this article seeks to provide a concise summary of TERM progress in Asia throughout the preceding ten years. A brief overview is given on the creation of innovative biomaterials and related technologies, the discovery of fresh cell sources, and the uses of TERM in several tissues. Lastly, the accomplishments of TERM in Asia will be shown, encompassing significant papers, exemplary discoveries, clinical studies, and instances of commercial goods. There will be a discussion of the subject's present restrictions as well as potential future developments. Proposals and developments in medical tissue engineering along with regenerative therapies date back more than thirty years. Although there have been a number of successful attempts at tissue regeneration, TERT is still in its early stages and many fundamental questions remain unanswered. These include the selection of cell sources, the creation of materials specific to specific tissues, the establishment of particular bioreactors, and the building of complex structures.

Employment of 3D printing in the regenerative therapies

According to Veeman et al. 2021, The authors have implemented that three-dimensional printing, also known as 3D printing, has tremendous possibilities as a method of creating fabric-engineering scaffolds. This study has suggested the Applications of 3D printing are limited to a broad spectrum of biological materials in the domains of tissue engineering and regenerative medicine. Biopolymers like collagen, alginate in them silk broin, chitosan, cellulose, and starch are employed in many different fields, such as food, biomedical, agriculture, packaging, and pharmaceuticals, because of their biocompatibility, bioactivity, and biodegradability. Making 3D-printed scaffolds has several advantages, such as the ability to create intricate geometries, porosity, multicellular coculture, and growth factor consideration. More opportunities to create 3D components and substances with unique patterns and qualities are provided, in particular, by the increased manufacturing of biopolymers.

Figure 6: The concept of 3D printing in biomaterial characteristics

 Significant advancements have been made in the fields of tissue biology and regeneration medicine; at this point, a number of cutting-edge methods have been employed to create porous scaffolds that can be used for organ or regeneration of tissues in tissue technology. Because of their suitable qualities and biocompatibility, natural bio-polymeric components are frequently more suitable for creating and producing medical equipment than transient implantation and tissue regeneration materials (Veeman et al. 2021). The review is on the additive manufacturing of biopolymers, highlighting noteworthy developments, advancements, and trends in tissue engineering and regenerative medicine with prospective applications. Genetic engineering has promised the design and manufacturing of novel biomaterials based on artificial proteins. These biomaterials operate differently from their native counterparts, such as enhancing fiber construction themselves being assembled.

The future directions of regenerative therapies

Figure 7: Disease-specific regenerative therapies and advantages

According to Jarrige et al. 2021, authors have evaluated the progression of regenerative medicine in various aspects. The development observed in fields related to stem cell science has paved better foundations in their application in tissue engineering of damaged or ill tissues in human bodies. Growing evidence indicates that some of the effects that have been observed in patients treated by stem cell-based therapies are attributable to paracrine effects much less with respect to the time course of engraftment and survival of transplanted cells. Based on the opportunity to cross-conduct intercellular information transfer of bioactive molecules, extracellular biological barrier vesicle targets are being investigated for the chances of cell-free therapies. Thus, in this review, we begin with the consideration of a scientific article: the relevant literature defines regenerative medicine as the field of present-day medicine that is still developing and faces certain limitations and problems, explaining the focus on such pluripotent stem cell-developed products to repair some of the body’s organs such as the eyes, heart, and skeletal muscle and skin. The authors have specifically narrowed to targeted beneficial effects of EVs in these pathologic conditions to mitigate them, and discuss the challenges and working aspects of this cell-free approach. Last, they can conclude and look at the future of this field and at the same time show how it is possible to cautiously combine the various paradigms (Jarrige et al. 2021). These concepts that are mentioned in this review can be used to amplify therapeutic outcomes in preclinical models and their GMP for clinical trials use in the future. That is why, in case of an advanced RPE cell degeneration as in the case of late AMD for example, the presence of EVs may not be adequate to recapitulate all the RPE functions in an effort to initially save the surrounding retina. Thus, it may be replaced through cell therapy, with one form of endogenous RPE being replaced by another. Based on that as EVs regulate inflammation in retinal degeneration, it may be established how RPE transplantation and EV delivery will complement, and that EV therapy may have benefits for the patient’s visual acuity. This is especially the case considering that RPE-derived Compared to EVs derived from paracrine-acting, the respective EVs are not able to decrease the CNV cells. The approaches such as the above may be useful for multi-factorial diseases. For this reason AMD and may also protect grafted cells from degeneration.

2.3. Theories and Models

Model of the Technology Adoption Life Cycle

The Technology Adoption Life Cycle conceptual framework defines the manner in which consumers with varying characteristics embrace new technologies. This model is applicable more in the business aspect of regenerative medicine because it can assist a firm in gauging the market nuances and the best way to operate within it. Such are the first buyers of new technologies, who are ready to take certain risks to test new products. In the case of regenerative medicine, it can feature first adopters of the new stem cell therapies which may comprise specialized research centers and pioneering clinics (Häneke, and Sahara, 2022). Early adopters are a group of people comprised of those who can imagine the positive sides of new technologies and are ready to start investing. The early majority of this model are the pragmatists who use new technologies after observing that there is efficiency, gains, and lower risk. In regenerative medicine, the early majority could include ordinary doctors and patients who begin to turn to stem cell therapies when they become routinely practiced. The stage of late majority is considered as conservatives who switch to new technologies as soon as it becomes the order of the day.

Figure 8: Technology adoption life cycle model

For regenerative medicine, the examples of the late majority may include mid-size healthcare centers and patients with more conservative attitudes. Laggards are considered as skeptics who have the worst tendency to embrace new technologies in their societies. In regenerative medicine, it is possible to guess that laggards represent individuals who rather not try new methods and use more conventional ones. Knowledge of the status of the market at the various stages of the adoption cycle also becomes essential in the effort to market the products. This allows companies to market and/or develop their products to speak to all classes of adopter groups, hence a broader market in the long run (Haleem et al.2022). Thus, the concept acknowledges the attributes and requirements of each type, helping to develop tactics for introducing goods, setting prices, and defining distribution channels.

Model of value chain

The Value Chain notion is a tool that originates from the work of Michael Porter, which lets a company define activities wanted for the delivery of value to customers and achieving competitive advantage. This model becomes valuable for such businesses because it allows identifying the means by which this industry can improve the processes and design interventions that would create more value. This includes accepting and warehousing raw materials. In the case of regenerative medicine, it could entail acquiring high-quality stem cells and other biological products. This encompasses such activities as in the transformation process inputs are converted to final products. In regenerative medicine, this might cover areas such as the research and creation of stem cell treatments.

Figure 9: Value chain model

This comprises the act of delivering the final product which gets into the hands of the customer. In regenerative medicine, it could entail the movement and delivery of treatments to various health practitioners. Such activities focus on advertising and marketing of the products (Čabinová et al. 2021). In the case of regenerative medicine, they could entail raising awareness on the importance of stem cells for treating diseases among healthcare practitioners as well as patients. This also encompasses services that are usually provided in the post-purchase stages, for instance, customer care and product repair services.

Theory of the Diffusion of Innovation

The Diffusion of Innovations theory is the theory crafted by Everett Rogers that portrays how procedures that are original, and new pass-through cultures and at what speed they do it. This theory is closely related to the business aspects of regenerative medicine as it reveals how new treatments can be integrated into the healthcare industry and the patient’s demand system. In the field of regenerative medicine advanced techniques refer to new stem cell therapies and such a regenerative treatment. Adventure involves information dissemination about the new treatments and for this purpose, the Communication Channels are considered. Some of the communication methods that could be used in regenerative medicine are journals, conferences, and more directly targeting the healthcare practitioners (Jamieson et al. 2021). This aspect looks at the time it takes for the innovation to penetrate the respective fields. In regenerative medicine, the adoption timeline concerns different factors such as approval of the regulations, results of clinical trials, and others. This looks at the audience or group of people who are implementing the innovation. These are; healthcare providers such as physicians, surgeons, nurses, patients or beneficiaries, regulatory agencies, and even insurers.

Figure 10: Diffusion of innovation theory

Thus, it contributes to the creation of Awareness about new treatments. The treatments are received positively or negatively by the various individuals that the novel brings into focus. Most treatment decisions are taken by affected people either through accepting or rejecting the treatments. Applications are The new treatments are the new practices. The effectiveness and outcomes of treatments being applied are assessed, this makes the treatments to either be continued or not (Laurent et al. 2020). About Marketing Strategies, it is agreed that knowledge regarding the diffusion process facilitates the crafting of marketing strategies that are appropriate for each stage of adoption. Stakeholder Engagement It makes it easier to engage with other stakeholders once the uptake of the new treatments is made easier. Adoption Barriers provide Information on barriers that can intervene in the marketing process and improve market share, Also, Adoption difficulties can be found and become a solution for the market breakthrough.

Theory of Transaction Cost Economics

Transaction Cost Economics as formulated by Williamson explores how activities in an economy are shaped by the costs of the structures for entering into and executing transactions. This highlights that firms’ main function is to reduce transaction costs which are costs involved in suppliers’ search for buyers, contract negotiations, and monitoring of suppliers’ performances. Regarding the topic of regenerative medicine, TCE can be used to identify the organizational optimal form of cooperation for businesses. For instance, firms may opt to vertically integrate some of the stages of the chain to avoid uncertainty and enhance quality.

Figure 11: Transaction Cost Economics Theory

They might decide to reach out to talented partner firms for expertise and support in the form of services while outsourcing services to specialized outsourcing firms at a substantially lower price than building their in-house infrastructures (Zoppelletto, Bullini and Rossignoli, 2020). Furthermore, recognizing the existence of asset specificity and information asymmetry inherent in resource investments for innovative medical technologies, TCE emphasizes the necessity of the contractual risks’ protection and relationship management in the development and commercialization of new value-additional technologies and medical equipment.

2.4 Literature Gap

The gaps in the research help to know that in which aspects the selected articles have some missing information. So the limitations of the study help to correct the misinterpretation of those studies. Substantial progress has been made in growing human tissues and organs using strategies such as 3D and bio printing but still, future technologies face challenges of translation from the laboratory into the clinics (Turner, 2021). The studies show that there exist major issues related to the complexity of national regulatory and legal systems, which become an important obstacle to the global spread and marketing of RM therapies. Our results also highlighted the need for convergence of these regulations apropos to the changes in the approval processes and cooperation in the development of RM between countries. The articles describe the changes in the business models adopted in the RM sector, identifying the fact that a large number of actors are SMEs and universities. However, there is a lack of knowledge about the right business models that can effectively fund the development and commercialization of RM therapies, especially with regard to manufacturing hurdles and market access constraints. Substantial progress has been made in the field, however, few RM therapies have been translated from the pre-clinical stage to clinical application. Subsequent studies are required to improve the knowledge about overall effectiveness as well as risks, and immunological issues of RM strategies in different groups of patients (Cao, and Ding, 2022). Consequently, the fast development of the RM market creates ethical issues on its accessibility and affordability of the treatments, and issues related to unapproved stem cell therapy. Thus, further research efforts should be directed towards these socio-economic and ethical features to enable responsible advancements.

2.5 Conceptual Framework

Figure 12: Conceptual Framework

The conceptual framework of the study has explained the dependent and independent variables of the study. So this study has represented that the dependent variable is the market adoption of this regenerative medicine. This is dependent on the market adoption strategies in which it can enhance in the global market (Neishabouri et al. 2022). The independent variables are the clinical safety of the trial systems of those medicines. Adopted suitable business models with the regulation of proper environment are also the dependent variables as they help in the approval of the investigation in proper ways. Technological innovation is also considered the independent variable for this study as the business aspects directly depend on the innovation of the technologies.

2.6 Conclusion

In conclusion, it can be concluded that this chapter on the investigation of the business aspects of regenerative medicine has accumulated valuable information from the previous preexisting journals which are already been evaluated by several authors. So this relevant information has helped to gain an understanding in which ways the business aspects of regenerative medicine can be impactful in the medicine field. So this study has effectively represented several journals in which several authors have described the impact of regenerative medicine and how can this type of business of medicine be helpful to others. The several articles have helped to accumulate the information for this investigation. Suitable theories and models have also been represented in this which are required to be applied for better outcomes. The gaps of the selected research have also been represented in this which are required to be fulfilled in future studies. The conceptual framework for this study has also been displayed in this study to understand which are the dependent or independent variables. So this study has successfully represented the relevant information in this chapter.

Chapter 3: Methodology

3.1. Introduction

HELEN BIOMED is a popular Japanese regenerative leading brand for medicine products that takes the initiative to provide treatment of stem cells which evolved the regenerative medicine field (Bawa et al. 2021). Therefore, the present research study followed the “secondary qualitative research methodology” to identify the appropriate business model market strategies and key challenges for Helen Biomed which are discussed as follows.

3.2. Method outline

HELEN BIOMED is a popular biomedical group that takes several initiatives for development of the market commercialization and promising outcomes for the patient groups. Therefore, the adoption of the “secondary qualitative” research design is the appropriate methodology structure that helped to investigate the appropriate business models, financial approaches, and marketing positioning strategies that can be easily identified (Bartolotti et al. 2021). The adoption of the “Positivism research philosophy” helped to address the scientific analysis of several business challenges and treatments related to stem cell treatment. Adoption of the “quantitative design” helps to gather the necessary and relevant data for evaluating the financial approaches that are followed by the HELEN BIOMED. The “mono research method” is also used to analyze the ethical guidelines and the strategies that are followed by the HELEN BIOMED [Referred to Appendix 1].

3.3. “Research Onion”

Figure 13: Research Onion

3.4. “Research Philosophy”

The “research philosophy” is considered an important section in the entire “research methodology section’ that often helps to identify the key problems and challenges that are faced by HELEN BIOMED, the strategies of problem-solving that can be adopted by HELEN BIOMED. Therefore, the adoption of the “interpretivism research philosophy” is the appropriate philosophy that can be adopted by HELEN BIOMED to address the key challenges and the business model that can be adopted by HELEN BIOMED in the context of the competitive marketing context (Helén and Tarkkala, 2022). Adoption of the “interpretivism research philosophy” helped to explore the complex, interrelated factors that influenced the overall “stem cell treatment” process of HELEN BIOMED. Also the “interpretivism philosophy” provides personal perspectives for analyzing the key business models, challenges, and factors that are adopted by the HELEN BIOMED. However, the subjective nature of this type of “interpretivism philosophy” is the main disadvantage of using this type of “interpretivism philosophy” is experienced during analyzing the HELEN BIOMED’s business model, and sustainable approaches.

3.5. “Research approach”

The “research approach” helped to identify the scientific understanding of key marketing strategies, business models, sustainability approaches, and ethical guidelines followed by HELEN BIOMED for providing “stem cell treatments” (Nugud et al. 2022). Therefore, the present research study followed the “inductive research approach” to identify the financial approaches, business models, and marketing positions that are followed by the HELEN BIOMED. Adoption of this type of “inductive approach” helped to examine the key patterns that are followed by HELEN BIOMED for providing the “stem cell treatments”. In other words, the adoption of this type of “inductive research approach’ helped to promote the overall problem-solving and managing performances of HELEN BIOMED for giving the “stem cell treatment”. However, this type of “inductive research approach” is time-consuming and creates some challenges to gather the relevant and necessary information regarding financial approaches, ethical guidelines, business model followed by HELEN BIOMED.

3.6. “Research Design”

The “research design” is another vital part of the entire “research methodology section” that helped to understand the various strategies that are followed by HELEN BIOMED for providing the “stem cell treatment”. In general, there exist mainly two types of research design “qualitative research design and quantitative research design” (Kidha, 2020). However, this present research study followed the “secondary research methodology” for which the “qualitative research design” is used for addressing business sustainability ethical guidelines and the financial sustainability measurements.

Figure 14: Research design

Adoption of the “qualitative research design” also added versatile approaches for identifying the targeted “business models” of HELEN BIOMED for giving the “stem cell treatment”. The “qualitative research design” also helped to address the transplant treatment strategies that are used for providing damaged cell replacement and “stem cell treatment” (MacGregor et al. 2021). Therefore, the adoption of the “qualitative research design” process is a more useful approach that analyzes the ethical guidelines of HELEN BIOMED. However, the time consuming natures of the “qualitative research design” creates the main drawback for addressing the business model, and ethical guidelines followed by HELEN BIOMED [Referred to Appendix 2].

3.7. “Research Strategy”

The “research strategy” is another vital part of the entire “research methodology” section that follows an activity scheme for investigating the position of HELEN BIOMED in global competitive marking situations. There are different types of “research strategies” like “case study approaches, survey strategy, interview strategy, some action based strategy, etc.” The present research study of the “regenerative medicine business” of HELEN BIOMED followed the “case study approach” and the “action-oriented research approach” to identify the ethical guidelines, business models, financial approaches, techniques, and strategies that are used by HELEN BIOMED (Park et al. 2021). Adoption of this type of “action-oriented research strategy” helped to identify the key business challenges, and issues, that are faced by HELEN BIOMED in the global competitive markets. Similarly, the “case study approach” helped to develop component-based findings for identifying business models, financial approaches, and ethical guidelines. 

3.8. “Research method”

The “research method” plays a vital role in providing a systematic plan for addressing the key business model, financial approaches, and key challenges during “stem cell treatment” provided by HELEN BIOMED. There exist 3 main types of “research methods” “the mono method, the multiple methods, and the mixed method” (Takahashi et al. 2023). This present research study addressing regenerative planning of medical business followed the “qualitative research design”. Therefore, the “mono research method” provides a consistent approach for in-depth exploration of a specific understanding of challenges that are faced by the HELEN BIOMED for using the “stem cell treatment”. Usage of this type of “single research method” provides more insights into understanding the “business model”, ethical considerations, business challenges, and strategies of using “stem cell treatment” for HELEN BIOMED. Therefore, the “mono research method” is used for the identification of the market initiative strategy that is used by HELEN BIOMED. However, this type of “mono research method” also creates weaknesses and a comprehensive lack of analysis of the business model, and key marketing strategies that are followed by HELEN BIOMED.

3.9. “Data collection process”

The “data collection” part is the most vital section in all research analysis of the identification of the regenerative type of medical business used by HELEN BIOMED. The present research study followed the “secondary research” for which the “secondary qualitative data sources” are collected from various authentic websites, the official website of HELEN BIOMED, a scholarly article from “Google Scholar” for identification of the marketing strategies that are used for “stem cell treatment” (Umemura, 2022). Some authentic books are also used for the identification of the “stem cell treatment strategies”, market influence, business models, and financial sustainability approaches followed in the “regenerative type of medical business”.

3.10. “Data analysis process”

The secondary data sources are collected from various types of valid and authentic resources for understanding business models and marketing strategies used incase of “stem cell treatment”. Based on the “case study approaches” the “qualitative analysis is done based on various models, theories, and understandings.

3.11. “Research ethics”

The “research ethics” plays another important role in the overall research study that helped to address the ethical and fundamental principles that are followed during the entire research study process of the regenerative kind of medicine business. Therefore, the present research study of analyzing the regenerative business model principle of HELEN BIOMED followed the anonymity principle, integrity principle, responsibility, fair analysis, etc. This present research study also avoided any type of unbiased analysis or gave any favorable outcome based on manipulation (Journals.lww.com, 2024). Therefore, the present research study also followed the biased principle during research conductions. This present research study also avoids any kind of environmental degradation and the harmful effects during the analysis of business model principles of “stem cell treatment”. This present research study also maintains transparency and provides respectful, responsible behaviors during the entire research period.

3.12. “Research limitations”

The lack of time and the research cost of analyzing challenges and factors for proving “stem cell treatment” is the main limitation for the conduction of “Primary quantitative analysis”. Therefore, the absence of the “primary analysis” is the key limitation of the conduction of this given research study on the regenerative type of medical business by HELEN BIOMED. Usage of the “secondary qualitative design” also faced several challenges from out-of-date data sources. Most of the research articles followed different contexts for which the problem of finding out the exact match research answer is another big limitation of this particular research study. A problem of incomplete resources also creates a major lack of identification of the influential factor for proving “stem-cell treatment” (Kidha, 2021). Therefore, these are the major limitations that are faced in the identification of the regenerative kind of medical business followed by HELEN BIOMED for providing “stem cell treatment”.

3.13. “Time Plan”

Figure 15: Gantt chart

3.14. Conclusion

The “reverberative kind of medical business” of “stem cell treatment” plays a major role in allover healthcare industries. HELEN BIOMED is a popular biomedical group that provides “stem cell therapy” using different types of business approaches, ethical guidelines, and financial sustainability. Therefore, the above section elaborately describes the adoption of a “secondary qualitative research strategy” for identification of the HELEN BIOMED’s business model, financial challenges and sustainability approaches, operational strategies, and ethical management followed by HELEN BIOMED. The above section elaborately describes the relevance of the usage of the “secondary qualitative design” for the identification of the regenerative types of business strategies used by HELEN BIOMED.

Chapter 4: Findings and Analysis

4.1. Introduction

The chapter on the findings and analysis can guide in representing several articles which were accomplished by the authors. So this study can be able to represent the information related to the business on regenerative business more effectively. This chapter will collect the secondary data that are relevant to the context of the study and this can guide us properly to understand how those selected data can guide us in future studies. This has explained the findings of the different results which are accomplished by the different authors with the visual representation. The different findings of their papers are represented here and the discussions based on these are also elaborated in this. The discussion of the findings can help to summarise the data which have been found in these papers. 

4.2 Findings

The difficulties and barriers in the clinical developing of ATMPs

The rationale, objectives, and findings of the study focus on the complexity of ATMP as they represent new therapeutic strategies for diseases with few or no cure. Nevertheless, the clinical development of ATMPs is not devoid of certain difficulties or features that traditional medicinal products do not pose due to the nature of the products and the availability of more non-clinical information. The invasion into the patient’s body, as well as the requirement for special instruments, additionally challenges quality assurance (Goula et al. 2020). Currently, life-threatening diseases in which patients cannot receive standard therapy cannot undergo purely controlled, randomized clinical trials; approval of trials involving operations might be especially difficult. That is, physicians might be discouraged from using ATMPs because of vagueness and the assumed extra mile in tracking their patients’ progress and bureaucratic responsibilities. A clinical success therefore requires the HC professionals to be specialized in the management of the product through SOPs right from the collection of the product to the follow-up of the patients administered the product.

Figure 16: Alliance for Regenerative Medicine

There must be an escalating documentation system that is well-documented and traceable well more especially than the cellular products and the autologous transplants in order to ensure that the transmitted biomaterial undergoes the right process and is returned to the patient. As for the practical problems, the study points to such questions as the expansion of the patient’s stay in the clinic, and the need for highly qualified personnel, which may lead to clinic management’s unwillingness to use such therapies. Regarding human resources, clinics are confronted with decision-making concerning qualified employees on the clinical and institutional levels because of the low integration of ATMPs into clinics’ daily work. Furthermore, proper documentation on these products especially the ones with short shelf life or those that need specific conditions in transportation is very vital. Finally, the authors should be congratulated for the comprehensive overview and a very useful and up-to-date paper, which underlines that to handle ATMPs in clinical practice despite systemic and practical problems one needs good practical training, substantial traceability, and very precise documentation.

The strategies related to marketing on the ‘stem cell therapy’

The paper explores the patient/consumer side of an emergent, but currently highly questionable market for autologous stem cell therapies, as well as the techniques used by various providers to legitimize their offering. Stakeholders in this market focus on what their interventions can do for children and young people and rationalize their services to become more legitimate. However, the task arises of handling patients’ expectations perspective so as not to compromise their operations and income. This paradox is examined through the investigation of the clinic’s websites and clinicians delivering the aforementioned treatments. The authors employed some practices that create medical credibility such as scientific rhetorical images, patients’ oratories, and appeals to risk assessments and research, even if only cursory to stem cell therapy. They use what they call ‘tokens of legitimacy’, which includes membership to professional bodies, and academic associations. These strategies are aimed at reinforcing clinicians’ image as credible physicians even though the methods they utilize have not been scientifically approved. This marketing approach sometimes blurs the reality that stem cell therapies contain experimentation that can sometimes let the patients’ expectations run high. Marketing techniques also highlight the lack of risk in undergoing treatments as well as present choice as risky or benefit analysis and putting the bonus on the patient (MacGregor et al. 2021). Unfortunately, the clinics tend to emphasize that there are only minor adverse effects of autologous stem cell therapy and post warnings to patients to investigate the matter on their own. This portrayal of safety directly contradicts the science that there is still a great amount of uncertainty surrounding the effectiveness of these treatments within the clinic. Authors have also noted that the clinic uses numerous procedures on fabricating the impression of therapeutic gain. They frequently refer to the success rates without any clear parameters or materials available and demonstrate clinical cases involving improved results. All the above-discussed case studies are presented in a scientific way, which adds more credibility to the medical nature of the film. Some clinics show patient registries and outcome information to stand out and to justify efficiency for patients. The marketing strategies of treatment related to stem cells influence the representative capital of medicine to increase maintenance by following ethical guidelines. The proper rules and policies can help to carry the expectations by representing the treatments in an effective way. So the marketing approach of this business requires more concern as it can directly fulfill the expectations of patients. So the authors can be able to balance their expectations of them with their hopes .

Characteristics related to practical implications in the business related to regenerative medicine

Figure 17: Various regenerative medicine treatments

This study involved of 100 physicians about whom some characteristics of the regenerative medicine business need to be known. The majority of respondents were White (69%) and non-Hispanic or Latino (98%); the respondents were mainly located in the Northeast (39%) and the South (28%). The most frequent specialty of the identified physicians was PM&R (53%), of whom 79% claimed to have a subspecialty in sports medicine. Slightly more than half (54%) of the practitioners had at least 10 years of post-training practice experience. In terms of training in regenerative medicine, self-training and training through conferences formed the largest percentage at about 50% of the physicians; 35% of the physicians obtained their knowledge in regenerative medicine through fellowships. Of the physicians in the 2008 survey, slightly over half were in academic practice compared to those in private practice. Currently, 47% of established trainees into undertaking regenerative medicine procedures with 8% employed physician assistants or nurse practitioners into the undertaking of the procedures. Regarding the basic endowment fee, only 40% of the physicians were acquainted with the fee type, while 60% of the respondents knew about the facility fees on top of the professional fees (Chavez et al. 2021). The percentage distribution of patients receiving the top five most popular regenerative medicine treatments included “Platelet-Rich Plasma, Concentration of Bone Marrow” which came in second at 41%, microfragmented adipose grafting next at 36%, prolotherapy at 33%, and Bone Marrow Aspirate fifth at 21% (Charnoff et al. 2023). “Orthokine or Regenokine and Stromal Vascular Fraction” received the lowest level of recognition among all names as only one physician reported the usage of “Orthokine or Regenokine treatments”. Most of these treatments were applied to the “small and large peripheral joints, muscles, and tendons with Ligaments” although some of these treatments were applied to the spine exclusion being the MAAG.

Figure 18: Costs for each procedure in regenerative medicine treatment

The surveyed physicians received half the amount or even less than the target treatment cost from their patients. Expenses have omitted the amounts on the usage of facility and image guidance. As for the costs, the highest difference in prices was observed for the BMA procedure and the second highest for BMC. Financial differences were documented as to primary fields, practice type, regions, image guidance, and years since training. The costs of PRP treatment were also relatively high according to PM&R physicians’ feedback. In general, costs were seen to be higher in the private practice compared to the academic hospitals irrespective of the form of treatment offered or whether the treatment is central or peripheral. In this study most of the physicians which are about 96% recommended in stopping of the NSAIDs while 75% were recommended to stop for taking steroids (Qiu et al. 2020). So it has been observed that most of the physicians were conducted follow-up procedures after the specified intervals of the treatments. The visually represented box plots have helped to know about the costings of employed regenrative treatment among the suffered people.

Evalaution and execution of the care model

Figure 19: The advancement of regenerative medicine business

Regarding the evaluation of a regenerative medicine-enriched model of care, it was established that the need stands for the confirmation and implementation of regenerative-produced products and related interventions. The broad context from research and development to service line is made easy by adopting clinical priorities and patients’ needs. The switching of animal models to human disease requires them to look at endorsements from the regulations, implementation viewpoints, and the level of preparedness with respect to technology, translating, and clinic. Another component to the application of regenerative solutions is its focus on adding value compared to other forms of management in the environmental realm. The technologies proposed by the different medical scientist have helpsed to meeet the requirements of the patient with the employment of proper technology. Adterthat the proper service line should be employed for fulfilling the requirement. The several practices need to be employed to get the superior care for the patients. Then the advanced type of care model can be evolved with the help of technologies. The progression of the regenerative medicine helps to know the several patients about its benefits so that they can be able to apply in their condition. So this study has helped to know how the authors have organised the flowchart to generate the effective care model. The envisaged solution of systematic clinical usage of biotherapies requires effective clinical supply chain that covers sourcing, manufacturing, and delivery of biotherapy products to patients. Access to patients is well-managed through key points that help in either physical or virtual admission of the patient. These portals provide extensive services such as education programs, regenerative workup, clinical trial subject recruitment, and procurement of patient biomaterials, specialists’ referrals, delivery of regenerative treatments, and follow-up care within the scope of a specific patient’s plan. There are also incorporated practices regarding the collection, preservation, processing, and manufacture of Clinical Grade Bio Specimens for companion diagnostics and therapy in line with the precision medicine advancements (Yamada, Behfar, and Terzic, 2021). There is a need to establish ‘bio-insurance’ platforms primarily maintaining harmony, standardization, and work in progress in reference to the guidelines set out. Care delivery is conceived to include inpatient and outpatient processes will be accomplished by infrastructures that include regenerative multispecialty therapeutic suites. These suites are furnished with multimodal imaging and advanced visualization that enhances on-site manufacturing & processing facilities. Delivery protocols are formulated with care regimens and thus incorporate regenerative technologies into the care management strategies (Beheshtizadeh et al. 2022). Thus, specific outcomes are monitored to become incorporated into clinical recommendations and to allow for constant improvement of the quality and efficacy of the regenerative medicine-enhanced model of care [Referred to Appendix 4].

4.3. Discussion of Findings

HELENE Biomedical Group is a popular regenerative leading medicine brand in Japan which is evaluating for appropriate business model in the global competitive market. Therefore identification of the appropriate regenerative business model helped to establish the competitive marketing position of HELENE Biomedical Group. This high-tech kind of biotechnology company often emphasizes development and research. 

The business model of HELENE Biomedical Group and its marketing position

The key aim of the HELENE Biomedical Group was to become the world’s most promising cutting-edge “Research and development” biomedical group that provides reliable and first-class service and care. HELENE Biomedical Group first obtained medical licensing for the ICU, anesthesia, and surgical procedures by using stem cell science in 2005 (Fears et al. 2021). It was found that the HELENE Biomedical Group followed the systematic administration for providing stem cells. The entire executive team of the HELENE Biomedical Group always followed optimism and a positive attitude towards any kind of new challenges regarding stem-cell operations. “Research and Development” is the key strategies of HELENE Biomedical Group that help to promote stem cell operations. The service activities of the HELENE Biomedical Group are divided into different departments medico, Rud, advanced surgeons, International and Domestic medical materials, Panakeia clinic, etc. HELENE Biomedical Group also has some technical advantage that promotes its marketing position in the global competitive situation. HELENE Biomedical Group only does the most demanding IV transplants with the laboratory/CPC in Japan. The HELENE Biomedical Group promotes the “state-of-the-art cell culture center” with its advanced, large equipment and research center. The professional expert medical team members of HELENE Biomedical Group offer specialized medical services (Goto et al. 2021). HELENE Biomedical Group also promotes the posterior articular type of collection surgery that significantly helps the physiological and psychological burdens of the patients. This unique feature determines the leading marketing position of the HELENE Biomedical Group in the global competitive market. It is also found that HELENE Biomedical Group provides the “stem cell operational service” for approximately 14000 services over 10 years. The customers get a diverse service range from the 15 of regenerative kind of medicine programs. It is also found that Japan established a law for regenerative medicine which provides big advantages for HELENE Biomedical Group to maintain its global position as a regenerative medicine service provider. Therefore, the above section found that the adoption of the care model helps to evaluate the regenerative medicine business for the HELENE Biomedical Group. The establishment of the “regenerative medicine-enriched model” provides the care for the implementation and confirmation of the development intervention for the HELENE Biomedical Group. 

Evaluation of the sustainability and financial approach for the operation time within group management

Financial requirements is one of the key requirements for providing this type of advanced regenerative type of stem-cell operations. HELENE Biomedical Group followed a “market-in-approach” for providing every type of solution for financial barriers and the key challenges that are faced by the HELENE Biomedical Group. Therefore, HELENE Biomedical Group emphasized stakeholder participation for providing of sustainable financial approaches. Support from the stakeholders improves the financial sustainability of HELENE Biomedical Group. As a biotech venture, HELENE Biomedical Group needs to acquire adequate funds and relevant equipment that face several challenges for “R & D innovations” (Murata and Teshima, 2021). Therefore, HELENE Biomedical Group emphasizes its technological equipment for sustainability and financial equipment purposes. However, HELENE Biomedical Group often faced risk challenges for future business exposure to this type of stem-cell regenerative medical problem. Adoption of its own technology step is the key advantage for HELENE Biomedical Group to provide hi-tech stem-cell operation in the global competitive market. It was also found that “HELENE Biomedical Group” needed a solid foundation for business purposes (Qiu et al. 2020). The HELENE Biomedical Group focused on the development of a healthy growth set up for the entire society for which HELENE Biomedical Group emphasized on long-term solid growth operations. The “HELENE Biomedical Group” also focused on the positive type of operating cash flow by which “HELENE Biomedical Group” can easily achieve profitability operation. “Steady growth” is the key priority of HELENE Biomedical Group for which HELENE Biomedical Group emphasized on “market-in approach” for financial sustainability purpose. This type of “market-in approach” are the key factor that emphasizes on strong sustainable development of the The management group of HELENE Biomedical Group always maintains close collaboration and communication with the team members. All the members followed strong collaboration and communication with all present team members for handling any type of critical cases. Dr. Matsuoka, Sr. Shinichiro, and Sr. Mike are some popular physicians who provide strong communication and collaboration with the team members (Takashima et al. 2021). The cell Culture operation team also plays an important function for 24 hours of monitoring, culturing capacity, etc. HELENE Biomedical Group always did the third-party verification rules for maintaining financial stability for HELENE Biomedical Group. The HELENE Biomedical Group set the separate pricing group of xx Life Clinic, Helene Clinic, Natural Clinic, Tokyo Clinic, etc (Wong et al. 2023). HELENE Biomedical Group also received a 01% visit rate for stem-cell operations[Referred to Appendix 5]. 

Challenges and strategies that are adopted during the stem cell treatment

Demand for “regenerative stem cell operation” is continuously increasing. The market analysis found that the demand for facial rejuvenation and anti-aging stem cell treatment increased by 53%. The customers also seek treatments for hyperlipidemia, hypertension, diabetes, and hyperglycemia. Approximately, 97% of customers are facing challenges from Parkinson’s disease, autoimmune diseases, and lupus erythematosus (Umemura and Morrison, 2021). An increasing of competition for the regenerative type of stem-cell operation also creates challenges for HELENE Biomedical Group. The regenerative stem-cell operation has also increased in recent years demand reflecting the increasing marketing competition for the stem-cell operation for HELENE Biomedical Group. It is also found that the plans for stem cells increased by 209% during the Covid-19 period. 

Identification of the global challenges also helped to improve the stakeholder's performance for this type of regenerative type of stem-cell operation. The HELENE Biomedical Group adopted the “exosome processing services” for the regenerative services. The HELENE Biomedical Group also started the “contract processing business” that helps to develop the overall processing technologies (Uyama et al. 2021). The HELENE Biomedical Group continuously working on its “R & D” that improve the “regenerative medical services”. The HELENE Biomedical Group also emphasized the establishment of a Cell Bank and Cord Blood for future regenerative medicine. The HELENE Biomedical Group also worked on “R & D of cosmetics” for which adopted some “adipose-derived stem cells”. The HELENE Biomedical Group also adopts the “R &D medicine” that provides versatile proprietary. The HELENE Biomedical Group also used medical tourism to provide international travel agencies as a foreign treatment supply. 

Identification of the isolated type of stem cells is one of the major challenges that are faced during providing stem cell operations (Manchikanti, et al. 2024). Therefore, the adoption of the Hitech equipment can improve the performance of stem-cell operations. Prevention of immune rejection and cell transplantation is also another problem that often creates challenges for providing stem-cell operations. Therefore, HELENE Biomedical Group can use the banking system for the reduction of the recipient and donor for “HELENE Biomedical Group”.

Based on the above paradox the HELENE Biomedical Group can adopt the clinician's deliveries that help to improve the strategies for regenertive types of medical stem-cell treatment. Therefore, HELENE Biomedical Group can adopt different types of strategies for enhancing the entire transplantation therapy for stem cell operations (Harada et al. 2021). Adoption of different facilities of preconditioning strategy, improvement of the microenvironment, heat shock, oxidative stress, hypoxic injury, and ischemic pretreatment can improve the regenerative medical service of HELENE Biomedical Group. Excise regularly also helps to improve the regenerative stem-cell operations for the HELENE Biomedical Group. HELENE Biomedical Group can adopt some advanced technologies and collaborate with other regenerative medical services to improve the operational strategies of stem cells. Therefore, the adoption of the wide range of stem-cell operations helps to improve the stem-cell operation and overcome the challenges that are faced from the entire regulation setup[Referred to Appendix 6]. 

Ethical guidelines for application and sourcing of stem cell treatments among participants

The stem-cell operation raises some ethical problems regarding disposable of the human embryos for benevolent purposes. Therefore, there are some ethical objections to the stem-cell therapy. Therefore the issue of regulation for stem cell operation is a major problem for managing the controversial challenges by HELENE Biomedical Group. It is also identified that the destruction of stem cell operations is considered unethical. The HELENE Biomedical Group provides stem cell operations for anti-aging treatment, Parkinson’s disease, hypertension, etc. Therefore, HELENE Biomedical Group faced some ethical challenges in the acquisition of this type of stem-cell treatment. However, the Japanese government also approved the regenerative services of The HELENE Biomedical Group and provided the “ISO 9001-certified” for regenerative medical treatments (Takayama et al. 2021). The HELENE Biomedical Group also produced the “Cell culture medium” based on animal-derived ingredients, manufacturing regulations, compliances, minimal differences, sell differentiations, confirmed osteoblast, etc. Therefore, HELENE Biomedical Group has to follow the ethical guidelines for the usage of this type of composition. The “Stem-cell treatment” of HELEN Biomedical Group should follow some ethical guidelines of general principles of safeguarding, dignity, safety, rights, and some fundamental freedom. Because the “Stem-cell treatment” is one type of process for which the HELEN Biomedical Group should have to follow the following ethical guidelines and principles. Noe, the HELEN Biomedical Group wants to expand its business to the Middle East, USA, Europe, and Africa. Therefore the HELEN Biomedical Group should follow the ethical guidelines and principles for providing stem cell treatments. 

Development and barriers in the wound healing and the function of stem cells

Figure 20: The presentation of global market sizes 

The application of natural compounds, stem cells, and miRNA-based biopolymers in wound healing is a groundbreaking advancement in the sphere of medicine. Scientifically, natural compounds originate from plants and biological materials and have proved to have anti-inflammatory and antimicrobial characteristics within the healing process. The role is played by stem cells, which through their ability to differentiate, can enhance tissue repair. In regenerative strategies such as scaffolds made of biopolymers, particularly those based on miRNAs, cell proliferation is aided, and the bioactive molecules are delivered for the process to be greatly boosted. These innovative approaches offer several advantages which are enlisted in this study. It improves their effectiveness due to the concurrent action of the multi-faceted mechanisms implied that would probably facilitate faster healing. They also cause fewer side effects than conventional treatment regimens and are thus well tolerated by the patients (Srivastava et al. 2024). More of them can offer better specific and accurate messages for the regeneration of tissues as in the case of wound healing, they offer improved outcomes of the whole healing process as well as less scar formation during the remodeling step and therefore better aesthetics. Nevertheless, wounds and especially chronic wounds are still a worrisome issue worldwide and are called the “silent epidemic.” The situation is multiplied in the developing countries where the lack of the necessary health care resources and infrastructure complicates the prompt diagnosis and treatment. More people across the world are living longer, many of whom are likely to pass through one or the other form of injury, and combined with rising rates of diabetes and obesity creates more people who need effective wound care products hence boosting the demand (Fani et al. 2024). That, in turn, creates a growing demand that has both financial implications but also fantastic opportunities for expansion in the global wound care market. Although research has made certain progress in using natural polymeric materials, stem cells, and miRNA, the effective treatment for chronic wound’ healing is still a difficult issue that presents opportunities for development and threats for chronic wound’ treatment. Global and regional market analysis of the wound care industry is addressed with details on both the global and each specific region’s standard and advanced wound care market. It is applied when routine treatments prove to be ineffective. It has been noticed between the years 2022 to 2030 that the predictions of analysts have offered prominent growth. It has been noticed that the total growth of $23,060 million annually. The market in Europe has resulted in $4,382 million.

The information related to the medicine in African region

Figure 21: The countries of africa implemented for therapies 

A cross-sectional study including physicians, postgraduate students, laboratory heads, and scientists in Africa showed that respondents’ awareness of precision medicine was overall moderate. More than 80% of the respondents reported that they were currently using or intending to use subsequent generation sequencing in their studies. Nevertheless, based on the analysis of 113 project descriptions submitted, it was noticed that only one-third of the projects were aligned well with the formal definition of PM, hinting at a lack of understanding of the concept, despite the utilization of related technologies. The respondents consisted of participants in twelve African nations; however, the survey did not extend to Central Africa. It showed that there was a major infrastructure problem, which was manifested as applicants having only a limited access to the vital resources such as biobanks, clinical laboratories, genomic analysis facilities, and computational tools; only 45 percent of the respondents claimed to have access to them. Less than half of the respondents were able to use all the required infrastructures for genomic investigation, indicating a that there is a major challenge in developing genomic medicine in the entire continent. However, there are advanced research laboratories in a few countries and they can possibly sustain regional work in genomic medicine (Jongeneel et al. 2022). Knowledge assessment of genomic medicine was poor and practice showed that few of the respondents’ institution had programs in it (Gebashe et al. 2022). Regarding data collection modalities, only 20 percent collected demographic and clinical data, and 34 percent were storing genomic data for sharing. In the group of national genomic medicine programs several countries were mentioned, such as South Africa, Tunisia, Zimbabwe, Egypt and Rwanda. But, it is still insignificant, just 14% of the respondents are assured their country’s scientists are prepared to practice precision or genomic medicine (Takayama, Kusamori, and Nishikawa, 2021). Again, a vast majority of the respondents understood the need for advances education and training. Some of the barriers to genomic medicine implementation as revealed by the survey include; poor infrastructure (81%) poor appreciation of disease risks among the local populace (64%) and poor genetic instructional menace among health professionals (67%). Fifty-five percent of the respondents stated that there is a view that genomic medicine is a low priority investment[Referred to Appendix 7].

4.4 Conclusion

In conclusion, it can be concluded that the findings of impact for the business related to the regenerative medicine is significant to understand its relevancy in the global market. The findings are elaborately described in this study to get a better understanding that how the effect of business of the regenerative medicine can be impactful in the countries of the Middle east, Africa and Europe. The context of the business of regenerative medicine has collected several articles to accumulate information on how the business has progressed effectively and it has also helped to understand how the acquired data can guide to improve the business.The findings frrom the different papers related to the regenerative medicine business are accumulated in this section where these can represent the significant information. The discussion on the findings of the different papers are represented in this section where the authors are denoted their results through their research. The discussion on the secondary data can help in understanding of the context effectively. This chapter also aligned with the previous chapters and helped in the establishment of the context which framed in the research objectives.

Chapter 5: Discussion

5.1 Introduction

The Discussion chapter is an equal type of critique of the findings within relation towards the business model, financial strategies and global positioning strategy of HELENE Biomedical Group within the regenerative medicine sector. In this chapter, it will be necessary to locate the group in terms of both achievement and problem solving on the background of the changes in its standings resulting from strategic management decisions. When looking at the group’s work, the discussion will also include the group’s performance based on the existing best practices and trends in the contemporary global environment. Another aspect of the analysis is going to be the consequences of their stem-cell operations in terms of ethical issues, specifically overarching their expansion into the Middle East, Africa, Europe markets. Moreover, this chapter shall discuss the implication of regenerative medicine across healthcare platforms and the relationship between HELENE Biomedical Group and the prevailing and emerging global healthcare needs. In this context, this chapter’s focus is to discuss the sustainability and scalability of the group in the context of the business model, and, hence, position it in the context of regenerative medicine.

5.2 Discussion of the findings

The outcomes from the detailed assessment of HELENE Biomedical Group business model and its activities in the sphere of regenerative medicine have strategic insights into the company’s market positioning. This discussion will analyze the outcomes that consider HELENE Biomedical Group practices in the perspectives of international tendencies and requirements, and assess the efficiency of the strategies used.

Business Model and Market Position

HELENE Biomedical Group is one of the market leaders in the context of the development of regenerative medicine, with emphasis on R&D and stem cell services. The business model of the group is directed on quality services and use of new technologies that provide the company with advantageous positions on the global market (Spratt et al. 2021). Since 2005, the company follows a strategic goal to become a leading biomedical group, which is reflected in the active use of stem cell science and related medicine, including ICU, anesthesia, and surgical activities. It is an inherent part of its business strategy since it enables HELENE Biomedical Group to provide clients with specialty services and has a competitive advantage.

The following are some of the reasons why this group has succeeded in its operations in the global dimension. Firstly, its investment in more technologically developed equipment, for example, a new cell culture center has affirmed its status of the market leader in the field of regenerative medicine. Technical improvements related to high technological types of equipment and qualified staff has boosted up its market status (Pramanik et al. 2023). The scope of operation of the group heading for a high demand service area of stem cell transplants and the capacity of the group to deliver around 14,000 services in a decade testifies the group’s capacity to serve a growing market.

Financial Sustainability and Stakeholder Engagement

Financial aspect is one that is central to Biomedical Group’s business model. They also show how the group manages the financial constraints using the ‘market-in’ mechanism, which is a proactive treatment of the economic limitations. With the focus of stakeholder involvement, Biomedical Group has been able to get funding and resources required for the day to day running of the company as well as support for the invention and development of Research and Development technologies. This has made it easy for the group to lay down a strong financial base and also experience long term success.

Despite the successes, Biomedical Group has problems that are connected with high costs of functioning in the area of the intensified stem cell usage and the necessity of the constant inventions. This has been somewhat addressed by the focus on technological equipment and that market-oriented financial strategy but the group’s future business exposure is still an issue, especially the global market competition conditions (Xia and Chen, 2022). The group has performed with an unbroken focus on growth and positive cash flow, making it on the right track to profitability despite having to constantly shift with market and financial realities[Referred to Appendix 8].

Challenges and Strategic Adaptations

The rapidly growing interest in regenerative stem cell treatments is both a strength and a weakness for Biomedical Group. The growing population of aging people who seek facial rejuvenation or other forms of treatments, has created a high degree of rivalry in the market (Arokiarajan et al. 2022). Furthermore, the presence of COVID-19 pandemic also helped increase the interest in stem cell treatment, proving that Biomedical Group needs to be more adaptive to other changes in the market.

In order to deal with all these problems, Biomedical Group has incorporated the following measures. Through the provision of the exosome processing services and contraction processing businesses, AE has improved its research and development in processing technologies. They show the active attitude of the group to innovations and its prospective to follow the tendencies in the field of regenerative medicine. Moreover, the establishment of the Cell Bank and Cord Blood services can also be viewed as a strategic measure and as the group’s attempts to broaden its portfolio of regenerative medicine services.

Ethical Considerations and Regulatory Compliance

Pertaining to the field of regenerative medicines, a primary focus is given to ethical issues and most especially to stem cells. HELENE Biomedical Group has experienced ethical dilemmas which concern the disposal of human embryos and the stem cell therapy as a whole. The group acknowledges and embraces the ethic and code of practices that govern the use of stem cells willingly complies with Japan legal provisions upon regenerative medicine, and the ISO 9001 (Suhag et al. 2023). It also mainly helps to determine that HELENE Biomedical Group mainly operates within the highest safety and ethical compliance with the law.

The group's new markets of operations including the Middle East, USA, European and Africa region requires the groups to conform to different ethical standards and regulations. Evaluating the ethical compliance for the different regions of the world can apply pressure on the group’s reputation and quality of functioning.

Wound Healing and Stem Cell Function

Use of stem cells in wound healing is mainly one of the major steps forward within the field of regenerative medicine. Use of natural compounds, biopolymers, and miRNA-based materials in the wound care has displayed improved benefits in tissue regeneration and scar tissue formation (Mahmoudi and Moss, 2020). The assortment of these methodologies includes several benefits, such as enhanced efficacy and lower complication rates which can be linked with traditional therapies.

The prevalence of chronic wounds remains unaddressed worldwide, especially in the developing world where the resources are scarce. The higher incidences of chronic wounds with growing incidence of diabetes and obesity contributes to the need for advanced wound care products. This growing demand signals potentially new market segments for HELENE Biomedical Group to penetrate and offer other products or services not yet well addressed in the market.

Regional Perspectives and Global Market Trends

The study of the worldwide and the various continental markets for wound care show there exist positive trends for growth. The global market of wound care products is estimated to have a great demand in the future, with Europe in the leading position by the size of the market (Pluchino et al. 2020). There are also new opportunities arising from the growing requirements for the implementation of more specialized products in the advanced wound care market for HELENE Biomedical Group to build on.

Currently there is quite limited translation and application of precision medicine and genomic technologies in Africa, and there is a lack of infrastructure and knowledge. However, the real and practical application of genomic medicine still remains relatively constrained, even if some advances could be acknowledged in contexts such as the South African, Tunisian, or Egyptian settings (Migliorini et al. 2020). Currently, low resources and awareness are some of the barriers to the implementation of precision medicine in the continent.

Understanding HELENE Biomedical Group business model, financing plans and positioning offers a huge insight of the company’s position in the regenerative medicine market. Their strategic focus on their R&D, technology and operations and their ethical business practices have put the group at the forefront of companies it operates globally. Nevertheless, some obstacles that are associated with financing, competitive pressure, and ethical question need to be solved in order to perpetuate the results (Zhang and Yelick, 2021). It also covers the effects of regenerative medicine to the health system and the diversification of the application of regenerative medicine to, for instance, the treatment of chronic ulcers. Due to the current opportunities and tendencies of regenerative medicines development HELENE Biomedical Group can further strengthen its position as a leader in this sphere.

5.3 Limitations

Several types of limitations to be recognized in spite of the findings that mainly emerged from the research that contribute greatly towards understanding the current type of state along with positioning of the Group of HELENE Biomedical. First thing is that the analysis mainly collects secondary data from premium channels, industry reports along with academic literature which may be not updated and lack detailed information of HELENE Biomedical Group (Srinivasan et al. 2021). As an effect, it may be possible to miss part of the contemporary type developments or some internal type processes that are not disclosed towards the public.

Secondly, the emphasis on reporting the company’s operations in the domestic market and the global markets including the Middle East, USA, Europe, and Africa might not accurately capture regional differences in the extent of regulatory compliance, market characteristics, and healthcare systems (Broxmeyer and Parker, 2020). This limitation may imply a limitation of the study generalisability to other regions characterized by different health care facilities and regulatory frameworks.

Moreover, the information about financial development and interacting with stakeholders is detected on the basis of the existing reports and may not state all the spheres of financial development as well as all the potential risks of HELENE Biomedical Group. It also lacks primary data gathered from respondents/interviews or query perhaps real feelings/concerns of the company which could enhance the richness of the context under study: financial initiatives and difficulties faced by the company. The discussed ethical type of considerations apply towards the Japanese regulatory setup along with may not necessarily cover ethical and regulatory type of concerns that HELENE Biomedical Group may encounter within other geographic type of locations (Javaid et al. 2023). The authorities that concentrate upon emerging technologies along with competitiveness within regenerative medicine are an ever-evolving field, and it can be considered that the research may not encompass all the innovative types of factors that impact the industry.

5.4 Summary

Here mainly conclude that understanding the nature of HELENE Biomedical Group and its financial management plan connected with its strategic positioning upon the global market that it is one of the leaders in the development of regenerative medicine solutions. Currently the group has ensured its leadership position by conducting strategic advanced R&D and aspiring for high quality service that stem cell applications along with best technology. This strategic plan has mainly promoted financial sustainability along with relations with the stakeholders that has ensured its long term development through the help of some of the problems like high operational cost and worldwide competition. Ethical type of issues and followings towards the regulations are also very important issues which should be considered within the process of the company’s development when it starts to penetrate into new markets. Complying with the ethical type of standards along with legal requirements of the country that make its operations beyond reproach and sustains the overall image of the group. It generates the overall growth potential that is very signified through the help of regenerative medicine for especially treating wounds along with chronic illnesses. The timely identification of new tendencies in the sphere of global healthcare and the company’s capability to adjust to these tendencies and conditions of certain regions will play a significant role in the development of HELENE Biomedical Group. The strategies that HELENE Biomedical Group has used and the product innovations makes it fit for further dominance and contribution in the field of regenerative medicine for the improvement of health care in the whole world.

Chapter 6: Conclusions

6.1. Introduction

The chapter on the conclusion represents the study of the regenerative business in medicine in a descriptive manner where it has linked with the objectives. These objectives are accomplished efficiently with the help of this study which was taken before the study. These objectives are required to be fulfilled in this study which has been represented in this chapter. The recommendations related to the study are also represented in this which is required to be accomplished in the future study. The study of the regenerative business of medicine has efficiently described all of the chapters by which the questions of the research can be answered.

6.2. Linking With Objectives

• To investigate the business model of HELENE Biomedical Group and its position in the global market.

The research investigates HELENE Biomedical Group Company and has found out that the business model in this particular company is a combination of both service operation and product-based model. In turn, with an emphasis on regenerative medicine and, in particular, stem cell therapies, HELENE can claim the company to be one of the market leaders in the field of health care (Umemura, 2022). The business model emphasizes a multi-faceted approach: programs, research and development, clinical use, and collaborations with academic and medical institutions around the world. In this way, having all types of service vertically integrated starting with obtaining stem cells and ending with treatment in particular, HELENE meets the need in the sphere of regenerative therapies. In the global market, the competitive advantage of HELENE is based on its willingness to invest in technologies and adapt the size of operations to global requirements. The following are the main objectives of the group: expansion plan; opening clinics in important global markets; and partnering with existing medical practitioners. This position is further supported by strategic relationships with technology companies that provide critical products for stem cell processing and genetic analysis. This, together with Innovation and expansion, HELENE Biomedical Group has been able to sustain its major operations in both the advanced and the developing economies.

• To evaluate the financial approaches and sustainabilities in the time of operations within the group management.

There are three main financial strategies in HELENE Biomedical Group; stakeholders’ funds management, multiple segment revenue, and constant capital investment in the Research and Development department. The study establishes a number of strategic financial flows that are employed in the investment in human resources the construction of first-class structures and the protection of patents. Such measures put HELENE in a position of being at par with the technological developments in the biomedical sector. As for sustainability, the group has put into action a close and long-term financial strategy that takes into account financial and ethical objectives. As for the problem of high prices on stem cell treatments, HELENE reduces them by forming partnerships with insurance companies, providing patients with installments, and getting state grants for innovative investigations. Also, the group has invested in renewable energy sources and green technologies with its aim of being environmentally responsible and improving operational expenses and corporate social responsibility.

• To analyze the several challenges with the various strategies at the time of stem cell treatment.

In this case, the programs of stem cell treatments contain scientific considerations as well as logistical ones. The nature of problems reflected in the activity of HELENE Biomedical Group concerns the effectiveness of treatments, patients’ safety, and compliance with the requirements. The study is interesting to the extent that it unmasks the finding of quality stem cells as being a herculean task since the stem cells need to meet strict international standards. One of the issues is the reproducibility of the treatment effect and the biological specifics: stem cells’ effectiveness can depend on the stem sources, patient characteristics, or the disease state. These challenges have been handled by the following strategies in HELENE; regarding personal healthcare treatment, the group leverages on patient individual characteristics to develop specific treatments. The models applied to clinical activities within HELENE improve the accuracy of the clinical procedures. Moreover, it has adopted a policy of continued medical education for its medical staff with a view to being in touch with current trends and practices in stem cell therapy. The study finds out that although there are obstacles that hinder the deliverance of services, owing to HELENE’s strategic management of innovation, high-quality delivery, and patient-centered care, the organization can overcome the challenges effectively.

• To examine the ethical guidelines in the sourcing and the application of stem cell treatments among patients.

Ethical factors are of great significance to the operational techniques employed by the HELENE Biomedical Group. The paper also explains how the group complies with the universally acceptable ethical practices in sourcing and using stem cells. HELENE obtains its stem cells from accredited suppliers and only uses stem cells from suppliers who adhere to legal standards regarding the rights of the donors of the stem cells. The group also observes strict measures in clinical trials and the treatment of patients including informed consent and full disclosure of possible risks as well as results of the study to the patients (Muthu et al. 2022). The study also shows how HELENE respects ethical protocols and directions such as the privacy of patients’ information, conflicts of interest, and equalized access to treatment. In as much as the group upholds these principles the group establishes credibility as well as doctoring the best practices from the international markets.

• To measure the influence of the treatment by HELENE Biomedical Group in getting desired outcomes.

The investigation evaluates the efficacy of HELENE’s stem cell treatments looking for clinical outcomes, patients’ reports, and follow-up assessments. The health treatment offered by HELENE has provided certain potentialities to minimize the effects of degenerative diseases, flexibility, and general well-being of the patients. Of interest, the group’s focus on follow-up appointments helps maintain patients ‘progress and adjust their treatment plans if needed in the long term (Mao et al. 2022). A research on patient satisfaction shows that patients have high confidence and express positive sentiments about stem cell therapy outcomes. Furthermore, the study points out that compared to similar clinical achievability these treatments have advanced regenerative medicine as evidenced by HELENE. This impact is evident in positioning the group as an innovator in the medical solutions provision and its ability to shape policies and practices in the healthcare sector.

6.3. Recommendations

Development of strategy and collaborative activities

Although this has developed significant partnerships worldwide, future opportunities for partnerships with research institutions as well as biotechnology companies can be achieved to increase innovation. Information sharing and mutual development of innovative therapies can be promoted through collaboration with universities and research institutions through the formation of joint ventures and research partnerships (Harris et al. 2022). Also, collaborating with governments and healthcare providers in emerging markets will diversify the patient-population base of HELENE and help it to tap more markets that are yet untapped. Such partnerships should include technology transfer to enable the enhancement of the growth and deployment of stem cells for treatment in the nation.

Investment in research and the improvement in medicine

Individualization of treatment is the solution to the problem of inter-patient differences in the effects of stem cells. To accentuate the highly personalized approach to treatments, HELENE should expand the company’s investments into better genomics, AI, and machine learning. The group said this investment will help them know individual patient characteristics and prognosis, as well as minimize risks. The real-time status of patients’ detailed data analysis is valuable in treatment planning and increasing the five-year treatment effectiveness. Establishing a separate R&D department to design a unique approach to stem cell therapy for each patient’s condition would not only make patients happier to work with HELENE but also would bring the company to the level of the leader in precision medicine.

Enhancement in the infrastructure with the technologies

There are gaps pointed out in this study especially as relates to availability and development of infrastructures as well as access to technology in different regions (Mousaei et al. 2022). As for the organizational development, HELENE should prospect the establishment of the regional centers to maintain the key infrastructure, including the biobanks during the subsequent years, mainly in Africa and Southeast Asia, as well as the genomic analysis labs and the data storage centers. Local researchers and clinicians can find training programs and other resources on their own in these hubs, and they can also be used as centers of excellence. It will also create a worldwide network of such hubs, which will create better cross-cultural and data-sharing research, and improve general research quality. HELENE should also consider the issue of innovative financing for this kind of infrastructural development such as public-private partnerships.

Establishment of ethical practices

Speaking of the further development of HELENE as an international company it is critical to mention that the higher the company grows, the more values ethical standards (Goddard, and Waterhouse, 2020). To gain the trust of the public and patients and to make them follow the procedures, the group should ensure that they come up with standard operating procedures in sourcing stem cells, obtaining consent from the patients, and protecting the personal information of patients. This means the institution should put into practice regular audits, the use of independent ethics committees as well as stock reporting systems when it comes to implementing these protocols. Further, it is imperative that HELENE should establish and implement a community and stakeholder awareness and sensitization program on ethical issues and best practices in regenerative medicine. They will also assist in managing ethical risk and improving the group’s reputation worldwide.

Enhancement in the training

According to the research conducted, the scarcity of talented professionals in stem cell technologies and regenerative medicine is rampant in several regions of the world, particularly in the developing world. HELENE should establish courses aimed at healthcare workers, laboratory staff, and scientists. These programs could be run in the form of workshops, online courses, and certification programs to discuss emerging technologies, ethical issues, and the best practices in stem cell treatment. This way when these ‘solutions’ are offered through partnerships with local universities and health-care organizations it would have a faster impact on the capacity building while contributing to the development of the branch of regenerative medicine as a whole.

6.4. Conclusion

It can be concluded that the study of the regenerative business in medicine has effectively completed all of the chapters. The objectives are linked in this chapter as they are accomplished through this study. The recommendations are also represented in this chapter which are required to be accomplished in the future purposes. The study has fulfilled the questions and objectives that were taken before the study and these have already been accomplished in this. The business of the regenerative study on the stem cell therapy is effectively described in all of the chapters to acquire the motive of the study.

Reference List

Book

Bawa, R., Chang, E.H., Audette, G.F., Diwan, A. and Faiz, S.A., 2021. Advances in Medical Biochemistry, Genomics, Physiology, and Pathology. Jenny Stanford Publishing. Available at: https://api.taylorfrancis.com/content/books/mono/download?identifierName=doi&identifierValue=10.1201/9781003180449&type=googlepdf [Accessed on; 13.07.2024]

Journals

Afifi, N.M., Anisimov, S.V., Aguilar-Quesada, R., Kinkorova, J., Marrs, S., Nassimbwa, S., Kozlakidis, Z. and Parry-Jones, A., 2020. Biobanking spotlight on Europe, Middle East, and Africa: presenting the collective experience of the ISBER-EMEA Regional Ambassadors. Biopreservation and Biobanking, 18(5), pp.471-478.

Andersen, M.M., Ogallo, E. and Diniz Faria, L.G., 2022. Green economic change in Africa–green and circular innovation trends, conditions and dynamics in Kenyan companies. Innovation and Development, 12(2), pp.231-257.

Armstrong, J.P., Keane, T.J., Roques, A.C., Patrick, P.S., Mooney, C.M., Kuan, W.L., Pisupati, V., Oreffo, R.O., Stuckey, D.J., Watt, F.M. and Forbes, S.J., 2020. A blueprint for translational regenerative medicine. Science translational medicine, 12(572), p.eaaz2253.

Arokiarajan, M.S., Thirunavukkarasu, R., Joseph, J., Ekaterina, O. and Aruni, W., 2022. Advance research in biomedical applications on marine sulfated polysaccharide. International Journal of Biological Macromolecules, 194, pp.870-881.

Bahari, M., Mokhtari, H. and Yeganeh, F., 2023. Stem Cell Therapy, the Market, the Opportunities and the Threat. International Journal of Molecular and Cellular Medicine, 12(3), p.310.

Bahari, M., Mokhtari, H. and Yeganeh, F., 2023. Stem Cell Therapy, the Market, the Opportunities and the Threat. International Journal of Molecular and Cellular Medicine, 12(3), p.310.

Banda, G., Mittra, J., Tait, J., Watkins, A. and Omidvar, O., 2021. Understanding the emergence and evolution of new business models in the UK regenerative medicine sector. Technology Analysis & Strategic Management, 33(3), pp.320-333.

Bartolotti, I., Roseti, L., Petretta, M., Grigolo, B. and Desando, G., 2021. A roadmap of in vitro models in osteoarthritis: a focus on their biological relevance in regenerative medicine. Journal of clinical medicine, 10(9), p.1920.

Beheshtizadeh, N., Gharibshahian, M., Pazhouhnia, Z., Rostami, M., Zangi, A.R., Maleki, R., Azar, H.K., Zalouli, V., Rajavand, H., Farzin, A. and Lotfibakhshaiesh, N., 2022. Commercialization and regulation of regenerative medicine products: Promises, advances and challenges. Biomedicine & Pharmacotherapy, 153, p.113431.

Beheshtizadeh, N., Gharibshahian, M., Pazhouhnia, Z., Rostami, M., Zangi, A.R., Maleki, R., Azar, H.K., Zalouli, V., Rajavand, H., Farzin, A. and Lotfibakhshaiesh, N., 2022. Commercialization and regulation of regenerative medicine products: Promises, advances and challenges. Biomedicine & Pharmacotherapy, 153, p.113431.

Broxmeyer, H.E. and Parker, G.C., 2020. Impact of COVID-19 and future emerging viruses on hematopoietic cell transplantation and other cellular therapies. Stem cells and development, 29(10), pp.625-626.

Čabinová, V., Gallo, P., Pártlová, P., Dobrovic, J. and Stoch, M., 2021. Evaluating business performance and efficiency in the medical tourism: a multi-criteria approach. Journal of Tourism and Services, 12(22), pp.198-221.

Cao, D. and Ding, J., 2022. Recent advances in regenerative biomaterials. Regenerative Biomaterials, 9, p.rbac098.

Coskun-Setirek, A. and Tanrikulu, Z., 2021. Digital innovations-driven business model regeneration: A process model. Technology in Society, 64, p.101461.

Erikainen, S., Couturier, A. and Chan, S., 2020. Marketing experimental stem cell therapies in the UK: biomedical lifestyle products and the promise of regenerative medicine in the digital era. Science as culture, 29(2), pp.219-244.

Erikainen, S., Couturier, A. and Chan, S., 2020. Marketing experimental stem cell therapies in the UK: biomedical lifestyle products and the promise of regenerative medicine in the digital era. Science as culture, 29(2), pp.219-244.

Fabi, S.G., Galadari, H., Fakih‐Gomez, N., Mobin, S.N., Artzi, O. and Dayan, S., 2023. Aesthetic considerations for treating the Middle Eastern patient: Thriving in Diversity international roundtable series. Journal of Cosmetic Dermatology, 22(5), pp.1565-1574.

Fani, N., Moradi, M., Zavari, R., Parvizpour, F., Soltani, A., Arabpour, Z. and Jafarian, A., 2024. Current advances in wound healing and regenerative medicine. Current stem cell research & therapy, 19(3), pp.277-291.

Fasseeh, A., Karam, R., Jameleddine, M., George, M., Kristensen, F.B., Al-Rabayah, A.A., Alsaggabi, A.H., El Rabbat, M., Alowayesh, M.S., Chamova, J. and Ismail, A., 2020. Implementation of health technology assessment in the Middle East and North Africa: comparison between the current and preferred status. Frontiers in pharmacology, 11, p.15.

Fears, R., Akutsu, H., Alentajan-Aleta, L.T., Caicedo, A., De Carvalho, A.C.C., Čolić, M., Cornish, J., Cossu, G., Debré, P., Dierckxsens, G. and El-Badri, N., 2021. Inclusivity and diversity: Integrating international perspectives on stem cell challenges and potential. Stem Cell Reports, 16(8), pp.1847-1852.

Foo, J.B., Looi, Q.H., Chong, P.P., Hassan, N.H., Yeo, G.E.C., Ng, C.Y., Koh, B., How, C.W., Lee, S.H. and Law, J.X., 2021. Comparing the therapeutic potential of stem cells and their secretory products in regenerative medicine. Stem cells international, 2021(1), p.2616807.

Galli, M., Yao, Y., Giannobile, W.V. and Wang, H.L., 2021. Current and future trends in periodontal tissue engineering and bone regeneration. Plastic and aesthetic research, 8.

Gay, M.H., Baldomero, H., Farge-Bancel, D., Robey, P.G., Rodeo, S., Passweg, J., Müller-Gerbl, M. and Martin, I., 2021. The survey on cellular and tissue-engineered therapies in Europe in 2016 and 2017. Tissue Engineering Part A, 27(5-6), pp.336-350.

Gebashe, F.C., Naidoo, D., Amoo, S.O. and Masondo, N.A., 2022. Cosmeceuticals: a newly expanding industry in South Africa. Cosmetics, 9(4), p.77.

Goddard, N.V. and Waterhouse, N., 2020. Regenerative Medicine, Stem Cell Therapies, and Platelet-Rich Plasma: Where Is the Evidence?. Aesthetic Surgery Journal, 40(4), pp.460-465.

Gopalan, N., Nor, S.N.M. and Mohamed, M.S., 2020. Regulation of stem cell technology in Malaysia: current status and recommendations. Science and engineering ethics, 26(1), pp.1-25.

Gopalan, N., Nor, S.N.M. and Mohamed, M.S., 2020. Regulation of stem cell technology in Malaysia: current status and recommendations. Science and engineering ethics, 26(1), pp.1-25.

Goto, T., Murata, M., Nishida, T., Terakura, S., Kamoshita, S., Ishikawa, Y., Ushijima, Y., Adachi, Y., Suzuki, S., Kato, K. and Hirakawa, A., 2021. Phase I clinical trial of intra-bone marrow cotransplantation of mesenchymal stem cells in cord blood transplantation. Stem Cells Translational Medicine, 10(4), pp.542-553.

Hahn, T. and Tampe, M., 2021. Strategies for regenerative business. Strategic Organization, 19(3), pp.456-477.

Hahn, T. and Tampe, M., 2021. Strategies for regenerative business. Strategic Organization, 19(3), pp.456-477.

Haleem, A., Javaid, M., Singh, R.P. and Suman, R., 2022. Medical 4.0 technologies for healthcare: Features, capabilities, and applications. Internet of Things and Cyber-Physical Systems, 2, pp.12-30.

Han, F., Wang, J., Ding, L., Hu, Y., Li, W., Yuan, Z., Guo, Q., Zhu, C., Yu, L., Wang, H. and Zhao, Z., 2020. Tissue engineering and regenerative medicine: achievements, future, and sustainability in Asia. Frontiers in bioengineering and biotechnology, 8, p.83.Jacques, E. and Suuronen, E.J., 2020. The progression of regenerative medicine and its impact on therapy translation. Clinical and Translational Science, 13(3), pp.440-450.

Häneke, T. and Sahara, M., 2022. Progress in bioengineering strategies for heart regenerative medicine. International Journal of Molecular Sciences, 23(7), p.3482.

Helén, I. and Tarkkala, H., 2022. Putting value on extracellular vesicles: practical economies of biomedical research and development. Science & Technology Studies, 35(3), pp.21-43.

Hennessy, C., Deptula, M., Hester, J. and Issa, F., 2023. Barriers to Treg therapy in Europe: From production to regulation. Frontiers in Medicine, 10, p.1090721.

Hu, W., Shi, J., Lv, W., Jia, X. and Ariga, K., 2022. Regulation of stem cell fate and function by using bioactive materials with nanoarchitectonics for regenerative medicine. Science and Technology of Advanced Materials, 23(1), pp.393-412.

Jacques, E. and Suuronen, E.J., 2020. The progression of regenerative medicine and its impact on therapy translation. Clinical and Translational Science, 13(3), pp.440-450.

Jacques, E. and Suuronen, E.J., 2020. The progression of regenerative medicine and its impact on therapy translation. Clinical and Translational Science, 13(3), pp.440-450.

Jamieson, C., Keenan, P., Kirkwood, D.A., Oji, S., Webster, C., Russell, K.A. and Koch, T.G., 2021. A review of recent advances in 3D bioprinting with an eye on future regenerative therapies in veterinary medicine. Frontiers in veterinary science, 7, p.584193.

Jarrige, M., Frank, E., Herardot, E., Martineau, S., Darle, A., Benabides, M., Domingues, S., Chose, O., Habeler, W., Lorant, J. and Baldeschi, C., 2021. The future of regenerative medicine: cell therapy using pluripotent stem cells and acellular therapies based on extracellular vesicles. Cells, 10(2), p.240.

Javaid, M., Haleem, A., Singh, R.P. and Suman, R., 2023. Sustaining the healthcare systems through the conceptual of biomedical engineering: A study with recent and future potentials. Biomedical Technology, 1, pp.39-47.

Jongeneel, C.V., Kotze, M.J., Bhaw-Luximon, A., Fadlelmola, F.M., Fakim, Y.J., Hamdi, Y., Kassim, S.K., Kumuthini, J., Nembaware, V., Radouani, F. and Tiffin, N., 2022. A view on genomic medicine activities in Africa: implications for policy. Frontiers in Genetics, 13, p.769919.

Khalilov, R., 2023. A COMPREHENSIVE REVIEW OF ADVANCED NANO-BIOMATERIALS IN REGENERATIVE MEDICINE AND DRUG DELIVERY. Advances in Biology & Earth Sciences, 8(1).

Kidha, D.K., 2020. Human embryonic stem cell research in transplantation and regenerative medicine: a principlist assessment (Doctoral dissertation, Stellenbosch: Stellenbosch University.).

Kieliszek, M., Bano, I. and Zare, H., 2022. A comprehensive review on selenium and its effects on human health and distribution in middle eastern countries. Biological Trace Element Research, 200(3), pp.971-987.

Laurent, A., Abdel-Sayed, P., Grognuz, A., Scaletta, C., Hirt-Burri, N., Michetti, M., de Buys Roessingh, A.S., Raffoul, W., Kronen, P., Nuss, K. and von Rechenberg, B., 2021. Industrial development of standardized fetal progenitor cell therapy for tendon regenerative medicine: Preliminary safety in xenogeneic transplantation. Biomedicines, 9(4), p.380.

Laurent, A., Abdel-Sayed, P., Scaletta, C., Laurent, P., Laurent, E., Michetti, M., de Buys Roessingh, A., Raffoul, W., Hirt-Burri, N. and Applegate, L.A., 2021. Back to the cradle of cytotherapy: Integrating a century of clinical research and biotechnology-based manufacturing for modern tissue-specific cellular treatments in Switzerland. Bioengineering, 8(12), p.221.

Laurent, A., Hirt-Burri, N., Scaletta, C., Michetti, M., de Buys Roessingh, A.S., Raffoul, W. and Applegate, L.A., 2020. Holistic approach of Swiss fetal progenitor cell banking: Optimizing safe and sustainable substrates for regenerative medicine and biotechnology. Frontiers in bioengineering and biotechnology, 8, p.557758.

MacGregor, C., Petersen, A. and Munsie, M., 2021. From the margins to mainstream: How providers of autologous ‘stem cell treatments’ legitimise their practice in Australia. Health, 25(1), pp.51-68.

Mahmoudi, M. and Moss, S., 2020. The absence of legal remedies following academic bullying. BioImpacts: BI, 10(2), p.63.

Manchikanti, L., Navani, A. and Sanapati, M., 2024. Evolution of regenerative medicine in managing musculoskeletal and spinal disorders. In Essentials of Regenerative Medicine in Interventional Pain Management (pp. 3-34). Cham: Springer International Publishing.

Master, Z., Crowley, A.P., Smith, C., Wigle, D., Terzic, A. and Sharp, R.R., 2020. Stem cell preservation for regenerative therapies: ethical and governance considerations for the health care sector. NPJ Regenerative Medicine, 5(1), p.23.

Master, Z., Matthews, K.R. and Abou-el-Enein, M., 2021. Unproven stem cell interventions: a global public health problem requiring global deliberation. Stem Cell Reports, 16(6), pp.1435-1445.

Migliorini, F., Tingart, M. and Maffulli, N., 2020. Progress with stem cell therapies for tendon tissue regeneration. Expert opinion on biological therapy, 20(11), pp.1373-1379.

Mosaddad, S.A., Hussain, A. and Tebyaniyan, H., 2024. Exploring the use of animal models in craniofacial regenerative medicine: a narrative review. Tissue Engineering Part B: Reviews, 30(1), pp.29-59.

Mukherjee, S., Yadav, G. and Kumar, R., 2021. Recent trends in stem cell-based therapies and applications of artificial intelligence in regenerative medicine. World journal of stem cells, 13(6), p.521.

Murata, M. and Teshima, T., 2021. Treatment of steroid-refractory acute graft-versus-host disease using commercial mesenchymal stem cell products. Frontiers in Immunology, 12, p.724380.

Neishabouri, A., Soltani Khaboushan, A., Daghigh, F., Kajbafzadeh, A.M. and Majidi Zolbin, M., 2022. Decellularization in tissue engineering and regenerative medicine: evaluation, modification, and application methods. Frontiers in bioengineering and biotechnology, 10, p.805299.

Nugud, A., Alghfeli, L., Elmasry, M., El-Serafi, I. and El-Serafi, A.T., 2022. Biomaterials as a vital frontier for stem cell-based tissue regeneration. Frontiers in Cell and Developmental Biology, 10, p.713934.

Park, M., Kim, H.M., Shin, H.A., Lee, S.H., Hwang, D.Y. and Lew, H., 2021. Human pluripotent stem cell-derived neural progenitor cells promote retinal ganglion cell survival and axon recovery in an optic nerve compression animal model. International Journal of Molecular Sciences, 22(22), p.12529.

Pluchino, S., Smith, J.A. and Peruzzotti-Jametti, L., 2020. Promises and limitations of neural stem cell therapies for progressive multiple sclerosis. Trends in Molecular Medicine, 26(10), pp.898-912.

Popowski, K., Lutz, H., Hu, S., George, A., Dinh, P.U. and Cheng, K., 2020. Exosome therapeutics for lung regenerative medicine. Journal of Extracellular Vesicles, 9(1), p.1785161.

Pramanik, S., Kharche, S., More, N., Ranglani, D., Singh, G. and Kapusetti, G., 2023. Natural biopolymers for bone tissue engineering: a brief review. Engineered Regeneration, 4(2), pp.193-204.

Qiu, T., Hanna, E., Dabbous, M., Borislav, B. and Toumi, M., 2020. Regenerative medicine regulatory policies: a systematic review and international comparison. Health Policy, 124(7), pp.701-713.

Qiu, T., Hanna, E., Dabbous, M., Borislav, B. and Toumi, M., 2020. Regenerative medicine regulatory policies: a systematic review and international comparison. Health Policy, 124(7), pp.701-713.

Ramadan, Q. and Zourob, M., 2021. 3D bioprinting at the frontier of regenerative medicine, pharmaceutical, and food industries. Frontiers in Medical Technology, 2, p.607648.

Ramezankhani, R., Torabi, S., Minaei, N., Madani, H., Rezaeiani, S., Hassani, S.N., Gee, A.P., Dominici, M., Silva, D.N., Baharvand, H. and Hajizadeh-Saffar, E., 2020. Two decades of global progress in authorized advanced therapy medicinal products: an emerging revolution in therapeutic strategies. Frontiers in Cell and Developmental Biology, 8, p.547653.

Spratt, E., Jordan, J., Winsten, J., Huff, P., Van Schaik, C., Jewett, J.G., Filbert, M., Luhman, J., Meier, E. and Paine, L., 2021. Accelerating regenerative grazing to tackle farm, environmental, and societal challenges in the upper Midwest. Journal of Soil and Water Conservation, 76(1), pp.15A-23A.

Srinivasan, M., Thangaraj, S.R., Ramasubramanian, K., Thangaraj, P.P. and Ramasubramanian, K.V., 2021. Exploring the current trends of artificial intelligence in stem cell therapy: a systematic review. Cureus, 13(12).

Srivastava, G.K., Martinez-Rodriguez, S., Md Fadilah, N.I., Looi Qi Hao, D., Markey, G., Shukla, P., Fauzi, M.B. and Panetsos, F., 2024. Progress in Wound-Healing Products Based on Natural Compounds, Stem Cells, and MicroRNA-Based Biopolymers in the European, USA, and Asian Markets: Opportunities, Barriers, and Regulatory Issues. Polymers, 16(9), p.1280.

Suhag, D., Thakur, P. and Thakur, A., 2023. Introduction to nanotechnology. Integrated Nanomaterials and their Applications, pp.1-17.

Takahashi, T., Donahue, R.P., Nordberg, R.C., Hu, J.C., Currall, S.C. and Athanasiou, K.A., 2023. Commercialization of regenerative-medicine therapies. Nature Reviews Bioengineering, 1(12), pp.906-929.

Takahashi, T., Donahue, R.P., Nordberg, R.C., Hu, J.C., Currall, S.C. and Athanasiou, K.A., 2023. Commercialization of regenerative-medicine therapies. Nature Reviews Bioengineering, 1(12), pp.906-929.

Takashima, K., Morrison, M. and Minari, J., 2021. Reflection on the enactment and impact of safety laws for regenerative medicine in Japan. Stem Cell Reports, 16(6), pp.1425-1434.

Takayama, Y., Kusamori, K. and Nishikawa, M., 2021. Mesenchymal stem/stromal cells as next-generation drug delivery vehicles for cancer therapeutics. Expert opinion on drug delivery, 18(11), pp.1627-1642.

Tu, R., Liu, X., Xu, L., Yao, X., Zhang, R., Li, J., Zhang, W., Liu, J., Wu, X. and Li, B., 2024. The current status and trends of oral bone regeneration materials: a bibliometric analysis from 1991 to 2023. Frontiers in Materials, 11, p.1420900.

Turner, L., 2021. The American stem cell sell in 2021: US businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell, 28(11), pp.1891-1895.

Umemura, M. and Morrison, M., 2021. Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience. Regenerative Medicine, 16(03), pp.269-282.

Uyama, H., Mandai, M. and Takahashi, M., 2021. Stem‐cell‐based therapies for retinal degenerative diseases: Current challenges in the establishment of new treatment strategies. Development, growth & differentiation, 63(1), pp.59-71.

Veeman, D., Sai, M.S., Sureshkumar, P., Jagadeesha, T., Natrayan, L., Ravichandran, M. and Mammo, W.D., 2021. Additive manufacturing of biopolymers for tissue engineering and regenerative medicine: an overview, potential applications, advancements, and trends. International Journal of Polymer Science, 2021(1), p.4907027.

Veeman, D., Sai, M.S., Sureshkumar, P., Jagadeesha, T., Natrayan, L., Ravichandran, M. and Mammo, W.D., 2021. Additive manufacturing of biopolymers for tissue engineering and regenerative medicine: an overview, potential applications, advancements, and trends. International Journal of Polymer Science, 2021(1), p.4907027.

Wong, R., Hejrati, N. and Fehlings, M.G., 2023. Clinical trials for neuroregenerative therapies for spinal cord injury: what have we learnt so far?. Expert Review of Neurotherapeutics, 23(6), pp.487-499.

Xia, B. and Chen, G., 2022. Research progress of natural tissue-derived hydrogels for tissue repair and reconstruction. International Journal of Biological Macromolecules, 214, pp.480-491.

Yamada, S., Behfar, A. and Terzic, A., 2021. Regenerative medicine clinical readiness. Regenerative Medicine, 16(3), pp.309-322.

Yoneda, T., Choi, B.H., Gupta, P.K., Ho, C.Y., Tsui, Y.P., Wang, L.M., Fujiwara, Y., Karasawa, H., Moriya, Y., Bando, K. and Kamiyama, Y., 2021. Non-clinical assessment of cell therapy products: the perspective from five Asian countries/regions based on regulatory guidelines and the underpinning rationales. Cytotherapy, 23(10), pp.874-885.

Zhang, W. and Yelick, P.C., 2021. Tooth repair and regeneration: potential of dental stem cells. Trends in molecular medicine, 27(5), pp.501-511.

Zoppelletto, A., Bullini Orlandi, L. and Rossignoli, C., 2020. Adopting a digital transformation strategy to enhance business network commons regeneration: an explorative case study. The TQM Journal, 32(4), pp.561-585.

Articles

Umemura, M., 2022. Challenging the Problem of ‘Fit': Advancing the Regenerative Medicine Industries in the United States, Britain and Japan. In The Business of Health (pp. 72-96). Routledge. Available at: https://www.taylorfrancis.com/chapters/edit/10.4324/9781003255987-4/challenging-problem-fitadvancing-regenerative-medicine-industries-united-states-britain-japan-maki-umemura [Accessed on; 13.07.2024]

Harada, K., Ozaki, A., Saito, H., Sawano, T., Yamamoto, K., Murayama, A., Senoo, Y. and Tanimoto, T., 2021. Financial payments made by pharmaceutical companies to the authors of Japanese hematology clinical practice guidelines between 2016 and 2017. Health Policy, 125(3), pp.320-326. Available at: https://www.sciencedirect.com/science/article/pii/S0168851020303043 [Accessed on: 21.07.2024]

Website

Journals.lww.com, (2024) Available at: https://journals.lww.com/plasreconsurg/abstract/2024/02000/comparable_effects_on_healing_between_autologous.22.aspx [Accessed on; 13.07.2024]

Value chain model