RESUMO
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.
Assuntos
Pesquisa com Células-Tronco , Transplante de Células-Tronco , Humanos , Pesquisa com Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco/métodos , Malásia , Guias como Assunto , Células-Tronco/citologia , Terapia Baseada em Transplante de Células e Tecidos/métodosRESUMO
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.
Assuntos
Células-Tronco Embrionárias Humanas/citologia , Patentes como Assunto , Políticas , Pesquisa com Células-Tronco/legislação & jurisprudência , Diferenciação Celular/genética , Autorrenovação Celular/genética , China , Guias como Assunto , Células-Tronco Embrionárias Humanas/metabolismo , Humanos , Pesquisa com Células-Tronco/ética , Transplante de Células-Tronco/métodosRESUMO
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.
Assuntos
Células-Tronco Pluripotentes Induzidas/metabolismo , Pesquisa com Células-Tronco/legislação & jurisprudência , HumanosRESUMO
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.
Assuntos
Gametogênese , Células Germinativas/citologia , Pesquisa com Células-Tronco , Células-Tronco/citologia , Animais , Diferenciação Celular , Células-Tronco Embrionárias , Células Germinativas/metabolismo , Humanos , Células-Tronco Pluripotentes Induzidas , Técnicas de Reprodução Assistida , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco , Células-Tronco/metabolismoRESUMO
The history of stem cell therapies is one of a limited number of clinical applications despite a vast therapeutic potential. Major breakthroughs in stem cell research have not yet enjoyed clinical success-all stem cell therapies bar hematopoietic stem cell transplantations remain experimental. With the increased risk of organ failure and neurodegenerative disease associated with our ability to push the boundaries of life expectancy comes an increased pressure to pioneer novel stem cell-based therapeutic approaches. We conclude that the failure of such therapies to achieve clinical translation stems from the polarising effect of the ethical debate around their use. The intractability of the ethical debate is double edged: legislators not only have placed tighter restrictions on certain stem cell therapies, but do so in favour of less controversial cells which will have worse outcomes for patients. It is by considering this relationship between the politics, ethics and science of stem cells that the reasons for the currently limited clinical significance of stem cell therapies be realised.
Assuntos
Terapia Baseada em Transplante de Células e Tecidos/ética , Terapia Baseada em Transplante de Células e Tecidos/métodos , Pesquisa com Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco/efeitos adversos , Transplante de Células-Tronco/ética , Humanos , Doenças Neurodegenerativas/terapia , Células-TroncoAssuntos
Quimera/embriologia , Pesquisas com Embriões/ética , Pesquisas com Embriões/legislação & jurisprudência , National Institutes of Health (U.S.)/legislação & jurisprudência , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Transplante de Células-Tronco/economia , Transplante de Células-Tronco/legislação & jurisprudência , Bem-Estar do Animal/ética , Bem-Estar do Animal/legislação & jurisprudência , Bem-Estar do Animal/normas , Animais , Cognição/fisiologia , Pesquisas com Embriões/economia , Organização do Financiamento/ética , Organização do Financiamento/legislação & jurisprudência , Organização do Financiamento/organização & administração , Guias como Assunto , Humanos , Primatas/embriologia , Pesquisa com Células-Tronco/economia , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco/ética , Fatores de Tempo , Reino Unido , Estados UnidosAssuntos
Pesquisa Biomédica/tendências , Governo Federal , National Institutes of Health (U.S.)/economia , Política , Pesquisa Biomédica/economia , Mapeamento Encefálico/economia , Células-Tronco Embrionárias Humanas , Humanos , Neoplasias/terapia , Neurociências/economia , Neurociências/tendências , Medicina de Precisão/economia , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Pesquisa com Células-Tronco/economia , Pesquisa com Células-Tronco/legislação & jurisprudência , Estados UnidosAssuntos
Terapia Baseada em Transplante de Células e Tecidos , Células-Tronco Embrionárias/transplante , Neoplasias/terapia , Pesquisa com Células-Tronco , Animais , Células Germinativas/citologia , Células Germinativas/metabolismo , Humanos , Camundongos , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/legislação & jurisprudênciaAssuntos
Terapia Baseada em Transplante de Células e Tecidos , Células-Tronco Embrionárias/transplante , Neoplasias/terapia , Pesquisa com Células-Tronco , Animais , Células Germinativas/citologia , Células Germinativas/metabolismo , Humanos , Camundongos , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/legislação & jurisprudênciaRESUMO
The most suitable donor for younger patients who undergo hematopoietic stem cell transplantation in the research setting is frequently a minor sibling. These cases raise the question of whether minors who serve as stem cell donors for research subjects should be regarded as research subjects themselves. Regarding pediatric donors as research subjects ensures that an Institutional Review Boards reviews their involvement and determines whether it is appropriate. Yet, Institutional Review Boards must follow the US regulations for pediatric research, which were designed for patients and healthy volunteers, not for healthy donors. As a result, regarding pediatric donors as research subjects also can pose unnecessary obstacles to appropriate and potentially life-saving research. This article considers a new way to address this dilemma. The federal research regulations allow for waiver of some or all of the included requirements when they are unnecessary for a study or a class of studies. We argue that this option offers a way to ensure that the involvement of pediatric donors receives sufficient review and approval without inadvertently undermining valuable and potentially life-saving research.
Assuntos
Transplante de Células-Tronco Hematopoéticas/ética , Pesquisa com Células-Tronco/ética , Obtenção de Tecidos e Órgãos/ética , Adolescente , Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Criança , Pré-Escolar , Comitês de Ética em Pesquisa , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Lactente , Sujeitos da Pesquisa , Pesquisa com Células-Tronco/legislação & jurisprudência , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Estados UnidosRESUMO
Stem cell tourism-the flow of patients from home countries to destination countries to obtain stem cell treatment-is a growing business in China. Many concerns have been raised regarding fraudsters that operate unsafe stem cell therapies and an officialdom that turns a blind eye to the questionable technology. The Chinese regulatory approach to stem cell research is based on Guidelines and Administrative Measures, rather than legislation, and may have no binding force on certain institutions, such as military hospitals. There is no liability and traceability system and no visible set of penalties for non-compliance in the stem cell legal framework. In addition to the lack of safety and efficacy systems in the regulations, no specific expert authority has been established to monitor stem cell therapy to date. Recognizing the global nature of stem cell tourism, this article argues that resolving stem cell tourism issues may require not only the Chinese government but also an international mechanism for transparency and ethical oversight. A stringent set of international regulations that govern stem cell therapies can encourage China to improve stem cell regulation and enforcement to fulfill its obligations. Through an international consensus, a minimum standard for clinical stem cell research and a central enforcement system will be provided. As a result, rogue clinics that conduct unauthorized stem cell therapies can be penalized, and countries that are reluctant to implement the reconciled regulations should be sanctioned.
Assuntos
Fraude , Transplante de Células-Tronco , China , Fraude/legislação & jurisprudência , Fraude/prevenção & controle , Regulamentação Governamental , Humanos , Turismo Médico/ética , Turismo Médico/legislação & jurisprudência , Pesquisa com Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco/ética , Transplante de Células-Tronco/legislação & jurisprudência , Nações UnidasRESUMO
UNLABELLED: Several human embryonic stem cell (hESC)-derived cell therapeutics have entered clinical testing and more are in various stages of preclinical development. The U.S. Food and Drug Administration (FDA) regulates these products under existing regulations and has stated that these products do not constitute a new class of biologic. However, as human tissue, hESCs are subject to regulations that were developed before hESCs were first described. The regulations have not been revised since 2005, well before the first hESC-derived product entered clinical studies. The current regulations require donors of hESCs to be tested in the same manner as donors of tissues intended for transplantation. However, because hESC-derived cell products are more than minimally manipulated, they are also subject to the same end-of-production release testing as most other biologic agents. In effect, this makes hESC products subject to redundant testing. No other biologic is subject to a similar testing requirement. Furthermore, the regulations that require donor testing are specifically applicable to hESC cells harvested from donors after a date in 2005. It is unclear which regulations cover hESCs harvested before 2005. Ambiguity in the guidelines and redundant testing requirements have unintentionally created a burdensome regulatory paradigm for these products and reluctance on the part of developers to invest in these promising therapeutics. We propose a simple solution that would address FDA safety concerns, eliminate regulatory uncertainty and risk, and provide flexibility for the FDA in the regulation of hESC-derived cell therapies. SIGNIFICANCE: Regulatory ambiguity concerning donor eligibility screening and testing requirements for human embryonic stem cell lines, in particular those lines created before 2005, are causing significant concern for drug developers. Technically, most of these lines fail to meet eligibility under U.S. Food and Drug Administration (FDA) rules for product licensure, and many developers are unaware that FDA approval to begin trials under an exemption is not an assurance that the FDA will grant licensure of the product. This Perspective outlines the ambiguity and the problem it has caused and proposes a workable solution. The intent is to generate stakeholder and FDA discussion on this issue.
Assuntos
Guias como Assunto , Células-Tronco Embrionárias Humanas , Pesquisa com Células-Tronco/legislação & jurisprudência , Doadores de Tecidos/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Produtos Biológicos/isolamento & purificação , Seleção do Doador/legislação & jurisprudência , Seleção do Doador/normas , Fidelidade a Diretrizes , Humanos , Segurança do Paciente , Estados Unidos , United States Food and Drug Administration/normasAssuntos
Pesquisas com Embriões/ética , Pesquisas com Embriões/legislação & jurisprudência , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco/ética , Transplante de Células-Tronco/legislação & jurisprudência , Alemanha , Regulamentação Governamental , HumanosRESUMO
Human pluripotent stem cells (hPSCs) have practically unlimited proliferation potential and a capability to differentiate into any cell type in the human body. Since the first derivation in 1998, they have been an attractive source of cells for regenerative medicine. Numerous ethical, technological, and regulatory complications have been hampering hPSC use in clinical applications. Human embryonic stem cells (ESCs), parthenogenetic human ESCs, human nuclear transfer ESCs, and induced pluripotent stem cells are four types of hPSCs that are different in many clinically relevant features such as propensity to epigenetic abnormalities, generation methods, and ability for development of autologous cell lines. Propensity to genetic mutations and tumorigenicity are common features of all pluripotent cells that complicate hPSC-based therapies. Several recent advances in methods of derivation, culturing, and monitoring of hPSCs have addressed many ethical concerns and technological challenges in development of clinical-grade hPSC lines. Generation of banks of such lines may be useful to minimize immune rejection of hPSC-derived allografts. In this review, we discuss different sources of hPSCs available at the moment, various safety risks associated with them, and possible solutions for successful use of hPSCs in the clinic. We also discuss ongoing clinical trials of hPSC-based treatments.
Assuntos
Células-Tronco Pluripotentes/citologia , Pesquisa com Células-Tronco/ética , Bancos de Espécimes Biológicos/ética , Técnicas de Cultura de Células , Linhagem Celular , Transformação Celular Neoplásica , Ensaios Clínicos como Assunto , Epigênese Genética , Rejeição de Enxerto/prevenção & controle , Antígenos HLA/imunologia , Humanos , Células-Tronco Pluripotentes/imunologia , Células-Tronco Pluripotentes/transplante , Medicina Regenerativa , Pesquisa com Células-Tronco/legislação & jurisprudênciaRESUMO
Among the many international conferences in the field of stem cells and regenerative medicine, WSCS is distinct in focusing its efforts to serve as the meeting point by multisector communities of research, clinics, industry, regulation, policy making and ethics. All are aiming at advancing stem cell innovation and new therapies, under the banner of 'connect, collaborate and cure'. As same as past years, presenters and attendees included not only researchers but also clinicians, funding agencies, government officials, industries and patients. Thus, many sessions focused on the clinical translation from basic research. Another important agenda were industrial and social aspects, and problems to be solved before realization of practical and sustainable stem cell-based therapies.
Assuntos
Células-Tronco/citologia , Ensaios Clínicos como Assunto , Humanos , Indústrias , Células-Tronco Mesenquimais/citologia , Políticas , Edição de RNA/genética , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco , TexasRESUMO
An opinion presented to the Court of Justice of the European Union on the patentability of parthenotes challenges the court's own competence in a notorious case on human embryonic stem cells.