The role of the International Society for Stem Cell Research (ISSCR) guidelines in disease modeling.

Human stem cell-based modeling systems are valuable tools that can greatly improve the clinical translation of basic research. Importantly, the successful application of human stem cell-based models to biomedical research depends on the widespread adoption of ethical principles and practical standards. To achieve this outcome, the International Society for Stem Cell Research (ISSCR) provides a comprehensive set of recommendations that aim to promote the ethical usage of human stem cells and to ensure rigor and reproducibility within the field. Understanding and implementing these recommendations should be a top priority for investigators around the world.

When boundaries benefit science and society.

In the rapidly moving field of stem cell and embryo research, research questions often sit at the intersection of scientific inquiry and ethical considerations. The International Society for Stem Cell Research (ISSCR) produces guidelines to help navigate decisions in this area. For Cell's 50th Anniversary Focus on Developmental Biology, scientific editor Sarah Geisler discussed the importance of the ISSCR guidelines on stem cell and embryo research for both the stem cell community and the broader public with Amander Clark, Robin Lovell-Badge, and Janet Rossant, who have been involved in the ongoing evolution of the guidelines. A lightly edited transcript of their conversation is shared here.

Rethink the patentability of human embryonic stem cell research findings: Relaxation based on benefit weighing.

Attitudes toward the patentability of the human embryonic stem cell (hESC) research findings are undergoing dynamic adjustment based on benefit weighing. In the early stage, ethical concerns prevailed: both the United States and China placed restrictions to some extent. As the science and technologies advance, the original balance has been broken. With a series of precedents and policies, the United States relaxes the conditions on hESCs. In this regard, China has established several rules mainly through patent examination practices. These rules are finally reflected in China's revised Guidelines for Patent Examination in 2020, which clearly defines the shift in China's stance.

Recognizing the ethical implications of stem cell research: A call for broadening the scope.

The ethical implications of stem cell research are often described in terms of risks, side effects, safety, and therapeutic value, which are examples of so-called hard impacts. Hard impacts are typically measurable and quantifiable. To understand the broader spectrum of ethical implications of stem cell research on science and society, it is equally important to recognize soft impacts. Soft impacts are the effects on behavior, experiences, actions, moral values, and social structures; these are often indirect effects of stem cell research. The combined notions of hard and soft impacts offer a broader way of thinking about the social and ethical implications of stem cell research and can help to steer stem cell research into a sociable desirable direction. Soft impacts enable researchers to become more aware of the broad range of significant implications involved in their work and deserve equal attention for understanding such ethical and societal effects of stem cell research.

Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: Considerations leading to the revised ISSCR guidelines.

The ISSCR Guidelines for Stem Cell Research and Clinical Translation were last revised in 2016. Since then, rapid progress has been made in research areas related to in vitro culture of human embryos, creation of stem cell-based embryo models, and in vitro gametogenesis. Therefore, a working group of international experts was convened to review the oversight process and provide an update to the guidelines. This report captures the discussion and summarizes the major recommendations made by this working group, with a specific emphasis on updating the categories of review and engagement with the specialized scientific and ethical oversight process.

ISSCR's Guidelines for Stem Cell Research and Clinical Translation: Supporting development of safe and efficacious stem cell-based interventions.

The ISSCR's revised Guidelines for Stem Cell Research and Clinical Translation reflect the organization's commitment to opposing premature commercialization of stem cell-based interventions and supporting the development of products that meet stringent ethical, scientific, and regulatory standards. The Guidelines contain five important new recommendations concerning clinical translation of stem cell products.

ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update.

The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.

ISSCR guidelines for the transfer of human pluripotent stem cells and their direct derivatives into animal hosts.

The newly revised 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation includes scientific and ethical guidance for the transfer of human pluripotent stem cells and their direct derivatives into animal models. In this white paper, the ISSCR subcommittee that drafted these guidelines for research involving the use of nonhuman embryos and postnatal animals explains and summarizes their recommendations.

The ethics of human-embryoids model: a call for consistency.

In this article, we discuss the ethics of human embryoids, i.e., embryo-like structures made from pluripotent stem cells for modeling natural embryos. We argue that defining our social priorities is critical to design a consistent ethical guideline for research on those new entities. The absence of clear regulations on these emerging technologies stems from an unresolved debate surrounding natural human embryo research and one common opinion that one needs to solve the question of the moral status of the human embryo before regulating their surrogate. The recent NIH funding restrictions for research on human embryoids have made scientists even more unlikely to raise their voices. As a result, the scientific community has maintained a low profile while longing for a more favorable socio-political climate for their research. This article is a call for consistency among biomedical research on human materials, trying to position human embryoids within a spectrum of existing practice from stem cell research or IVF to research involving human subjects. We specifically note that the current practices in infertility clinics of freezing human embryos or disposing of them without any consideration for their potential benefits contradicts the assumption of special consideration for human material. Conversely, creating human embryoids for research purposes could ensure that no human material be used in vain, always serving humankind. We argue here that it is time to reconsider the full ban on embryo research (human embryos and embryoids) beyond the 14-day rule and that research on those entities should obey a sliding scale combining the completeness of the model (e.g., complete vs. partial) and the developmental stage: with more advanced completeness and developmental stage of the considered entity, being associated with more rigorous evaluation of societal benefits, statements of intention, and necessity of such research.

Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia.

BACKGROUND: With the huge number of patients who suffer from chronic and incurable diseases, medical scientists continue to search for new curative methods for patients in dire need of treatment. Interest in stem cells is growing, generating high expectations in terms of the possible benefits that could be derived from stem cell research and therapy. However, regardless of the hope of stem cells changing and improving lives, there are many ethical, religious, and political challenges and controversies that affect the research, and mandated to establish ethical guidelines and regulations. In Saudi Arabia, key stakeholders play an active role in discussing the ethics of stem cell research and therapy. The focus of the study was to explore professionals' perceptions related to the ethical challenges of using stem cells in research and treatment in Saudi Arabia. RESULTS: A qualitative research study was conducted to explore and describe the perceptions of 25 professionals employed at different tertiary hospitals in the various regions of Saudi. A thematic analysis was performed to search for and identify the most significant perceptions shared by the participants. Four themes were generated based on the ethical challenges of four areas related to stem cell use, including (1) forbidden and permitted sources of stem cells, (2) informed consent, (3) beneficence, and (4) ethical regulations and guidelines. CONCLUSION: The study identified that there is a growing need to advance the knowledge, education, and awareness related to stem cell research and treatment in Saudi Arabia.

Regulation of Stem Cell-Based Research in India in Comparison with the US, EU and other Asian Countries: Current Issues and Future Perspectives.

Stem cell therapy is applicable for repair and replacement of damaged cells and tissues. Apart from transplanting cells to the body, the stem cell therapy directs them to grow new and healthy tissues. Stem cells in the area of regenerative medicines hold tremendous promise that may help to regenerate the damaged tissues and heal various diseases like multiple sclerosis, heart diseases, Parkinson's disease, and so on. To prove the safety, efficacy, and for the requirement of a licence for manufacturing and sale, all the stem cell therapies should pass the required criteria and undergo certain examinations of the regulatory agencies. The regulatory authorities review the manufacturing procedures of products to assure its purity and potency. This review summarizes the comparative critical evaluations of existing regulations and developments on the stem cells research in India, USA, EU and Asian regions and also discusses the challenges that have to be overcome and the important points that should be understood to position India as a source of the perspective nation in stem cells around the world.

Ethical Aspects of Translating Research with Human Pluripotent Stem Cell Products into Clinical Practice: A Stakeholder Approach.

Experimental therapies with embryonic stem cells (hESCs) and, more recently, human induced pluripotent stem cells (hiPSCs) are steadily gaining ground in clinical practice. The implementation of such novel high-risk/high-potential treatments calls for proper safeguards for the interests of the public and, most importantly, of research participants directly affected by the design and outcomes of trials. We argue that the active involvement of stakeholders in decision-making is ethically required. Public and patient involvement is a necessary prerequisite for dealing responsibly with high-risk/high-potential clinical research such as stem-cell research. Moreover, there is an urgent need for public debate, regionally and globally, about the present and future value of such types of research. A stakeholder approach that pays attention to all of the people and institutions involved, including patients and their organizations, will guide the translational process and maintain the public's trust in such a rapidly evolving scientific field.

EBCOG position statement: ethics of stem cell research.

Over the past 10 years' significant research developments have taken place on human pluripotent stem cells and human embryonic stem cells to exploit the future potential in gene therapy and other focused treatments. There remains concerns around ethics of research and the fate of the human embryo used in such studies. European Board and College of Obstetrics and Gynaecology urge upon all scientists and the research bodies to adhere to the highest ethical principles of confidentiality and their actions should meet the criteria as set out by the international society for stem cell research.

Regulation of Stem Cell Technology in Malaysia: Current Status and Recommendations.

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness of the current Guideline for Stem Cell Research and Therapy (2009) are examined. The study's findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation (2016) of the International Society for Stem Cell Research (ISSCR) containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders.