Current guidelines, challenges and future recommendations for regulation of stem cell research and therapy: a commentary.

In recent years, Malaysia has seen a surge in stem cell therapy for various medical conditions. However, the regulation of stem cell research and therapy in Malaysia faces several challenges such as the emergence of unregulated clinics and a lack of specific legislation. Some urgent measures, including enactment of specific laws, strengthened monitoring, as well as increased public awareness and education, are crucial. Therefore, stem cell therapy regulation requires concerted efforts by the policymakers, regulator bodies and healthcare professionals. This commentary discusses the current guidelines and challenges in Malaysian stem cell therapy regulation and proposes some future recommendations that could pave the way for responsible progress of stem cell research and therapy globally.

The variability of judicial decisions in the stem cell industry in China.

As China's stem cell industry continues to develop, increasing disputes concerning stem cell-based interventions have been brought before the courts. Nonetheless, there is variability in the courts' understanding and attitude toward the regulatory attributes of these interventions, which to some extent has multifaceted impacts on the stem cell field.

Work with embryonic stem cells - legal considerations.

Apparently, there is a broad scope of legal issues affecting the work with embryonic stem cells. I cannot address them all. I would like to focus on two fields of law and discuss, rather in the overview, some salient issues of German constitutional and administrative law framing the scientific research process. Compared to the sophisticated scientific work we discuss here, legal arguments and operations remain blunt and awkward, addressing rather the identity of a society than the fluid frontiers of science and technology.

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.

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.

Freedom of Scientific Research and Embryo Protection Under Italian and European Court of Human Rights' Jurisprudence. Brief European Legislation Overview.

The paper addresses the issues of admissibility of human embryo research and the legal protection to be recognized, in light of the growing importance that scientific research has been gaining in the clinical and biomedical fields of embryonic stem cells for therapeutic purposes. As for human embryo experimentation, particularly on cryopreserved supernumerary embryos, European legislation varies, since the European Court has granted member States a wide margin of appreciation. Some countries, including Italy, have strict legislation protecting embryos from the fertilisation stage, whereas others have taken permissive approaches, allowing experimentation until 14 days after fertilisation. Science, however, has shown that the 14-day limit can be moved. The author finds it necessary to achieve broad international consensus and shared regulations. Lawmakers, however, need to balance respect for the principle of life, represented by the embryo, against scientific needs, in order to devise sound regulations safeguarding both apparently conflicting fundamental values.

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.

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.

Key regulations related to stem cell research.

Medicine is an ever-changing science. Stem cell research is nowadays part of the medicine. After developments and trials for decades, in 1988 it was announced that a variety of diseases and injuries would be cured with new stem cell therapy, such as: cancer, diabetes, Parkinson's, spinal cord injuries and many others. After almost 10 years of research in the field, in 2007 other good news and hopes were announced: the possibility to create induced pluripotent stem cells, derived from somatic cells, easily used to establish any disease-specific cell line. And research is going on. In order to find answer to a variety of challenges in this area, a researcher faces the following main question: Which are the legislations and the normative standards to be taken into account when we are supposing to conduct a research on/with stem cells? The purpose of the paper is: (i) to familiarize professionals with the current steps in the evolution of stem cell research; (ii) to provide main legal orientations related to stem cell research; (iii) to indicate limits and explanations on legal regulations related to the research on stem cells.

Stem Cell-Derived Human Gametes: The Public Engagement Imperative.

The implications of scientific breakthroughs are rarely faced up to in advance of their realization. Stem cell-derived human gametes, a disruptive technology in waiting, are likely to recapitulate this historic pattern absent active intervention. Herein we call for the conduct of thoughtful ante hoc deliberations on the prospect of stem cell-derived human gametes with an eye toward minimizing potential untoward post hoc regulatory or statutory impositions.

Therapeutic abortion and ectopic pregnancy: alternative sources for fetal stem cell research and therapy in Iran as an Islamic country.

Regenerative medicine as a background of stem cell research and therapy has a long history. A wide variety of diseases including Parkinson's disease, heart diseases, multiple sclerosis, spinal cord injury, diabetes mellitus and etc. are candidate to be treated using different types of stem cells. There are several sources of stem cells such as bone marrow, umbilical cord, peripheral blood, germ cells and the embryo/fetus tissues. Fetal stem cells (FSCs) and embryonic stem cells (ESCs) have been described as the most potent stem cell source. Although their pluri- or multipotent properties leads to promising reports for their clinical applications, owning to some ethical and legal obstacles in different communities such as Muslim countries, care should be taken for therapeutic applications of FSCs and ESCs. Derivation of these cell types needs termination of pregnancy and embryo or fetus life that is prohibited according to almost all rules and teaches in Muslim communities. Abortion and termination of pregnancy under a normal condition for the procurement of stem cell materials is forbidden by nearly all the major world religions such as Islam. Legislated laws in the most of Muslim countries permit termination of pregnancy and abortion only when the life of the mother is severely threatened or when continuing pregnancy may lead to the birth of a mentally retarded, genetically or anatomically malformed child. Based on the rules and conditions in Islamic countries, finding an alternative and biologically normal source for embryonic or fetal stem cell isolation will be too difficult. On the one hand, Muslim scientists have the feasibility for finding of genetically and anatomically normal embryonic or fetal stem cell sources for research or therapy, but on the other hand they should adhere to the law and related regional and local rules in all parts of their investigation. The authors suggest that the utilization of ectopic pregnancy (EP) conceptus, extra-embryonic tissues, and therapeutic abortion materials as a valuable source of stem cells for research and medical purposes can overcome limitations associated with finding the appropriate stem cell source. Pregnancy termination because of the mentioned subjects is accepted by almost all Islamic laws because of maternal lifesaving. Also, there are no ethical or legal obstacles in the use of extra-embryonic or EP derived tissues which lead to candidate FSCs as a valuable source for stem cell researches and therapeutic applications.

A Crispr Future for Gene-Editing Regulation: a Proposal for an Updated Biotechnology Regulatory System in an Era of Human Genomic Editing.

Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual's genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government's ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.