Iinovations and Solutions Inc. FSU Tallahassee AMET University Global, United States.
Curr Drug Targets. 2019;20(4):388-398. doi: 10.2174/1389450119666180831095830.
Stem Cell Research and Tissue Engineering, in present time, have emerged as a legalized and regulated stem cell treatment option globally, but scientifically, their success is unestablished. Novel stem cell-based therapies have evolved as innovative and routine clinical solutions by commercial companies and hospitals across the world. Such rampant spread of stem cell clinics throughout UK, US, Europe and Asia reflect the public encouragement of benefits to incurable diseases. However, ever growing stem cell therapy developments need constant dogwatch and careful policy making by government regulatory bodies for prompt action in case of any untoward public concern. Therefore, researchers and physicians must keep themselves abreast of current knowledge on stem cells, tissue engineering devices in treatment and its safe legal limits. With this aim, stem cell scienctific developments, treatment options and legal scenario are introduced here to beginner or actively inolved scientists and physicians. Introduction to stem cell therapy will provide basic information to beginner researchers and practice physicians on engineered stem cell research concepts and present stem cell therapy federal regulations in different North American, European and Asian countries. FDA, CDC, EU, ICMR government policies in different countries include information on the current legal position, ethical policies, regulatory oversight and relevant laws.
目前，干细胞研究和组织工程已经成为全球合法化和规范化的干细胞治疗选择，但从科学角度来看，其成功尚未得到证实。世界各地的商业公司和医院已经将新型基于干细胞的疗法发展为创新和常规的临床解决方案。英国、美国、欧洲和亚洲的干细胞诊所如雨后春笋般涌现，这反映了公众对治疗不治之症的益处的鼓励。然而，不断增长的干细胞治疗发展需要政府监管机构不断关注和谨慎制定政策，以便在出现任何公众关注的不当问题时迅速采取行动。因此，研究人员和医生必须了解当前关于干细胞、组织工程设备在治疗中的应用及其安全合法限制的最新知识。为此，本研究介绍了干细胞科学的发展、治疗选择和法律现状，供初学者或积极参与的科学家和医生参考。干细胞治疗的介绍将为初学者研究人员和实践医生提供关于工程化干细胞研究概念的基本信息，并介绍不同北美、欧洲和亚洲国家的联邦干细胞治疗法规。不同国家的 FDA、CDC、EU、ICMR 政府政策包括当前法律地位、伦理政策、监管监督和相关法律的信息。
