National Stem Cell Resource Center, State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Institute for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing, People's Republic of China.
Beijing Institute for Stem Cell and Regenerative Medicine, Beijing, People's Republic of China.
Stem Cells Transl Med. 2021 Nov;10 Suppl 2(Suppl 2):S85-S95. doi: 10.1002/sct3.13035.
Stem cells, which could be developed as starting or raw materials for cell therapy, hold tremendous promise for regenerative medicine. However, despite multiple fundamental and clinical studies, clinical translation of stem cells remains in the early stages. In contrast to traditional chemical drugs, cellular products are complex, and efficacy can be altered by culture conditions, suboptimal cell culture techniques, and prolonged passage such that translation of stem cells from bench to bedside involves not only scientific exploration but also normative issues. Establishing an integrated system of standards to support stem cell applications has great significance in efficient clinical translation. In recent years, regulators and the scientific community have recognized gaps in standardization and have begun to develop standards to support stem cell research and clinical translation. Here, we discuss the development of these standards, which support the translation of stem cell products into clinical therapy, and explore ongoing work to define current stem cell guidelines and standards. We also introduce general aspects of stem cell therapy and current international consensus on human pluripotent stem cells, discuss standardization of clinical-grade stem cells, and propose a framework for establishing stem cell standards. Finally, we review ongoing development of international and Chinese standards supporting stem cell therapy.
干细胞可以作为细胞治疗的起始或原始材料进行开发，为再生医学带来了巨大的希望。然而，尽管进行了多项基础和临床研究，干细胞的临床转化仍处于早期阶段。与传统的化学药物不同，细胞产品较为复杂，其疗效可能会受到培养条件、细胞培养技术不佳以及传代时间过长等因素的影响，因此，将干细胞从实验室转化到临床应用不仅涉及科学探索，还涉及规范问题。建立一个综合的标准体系来支持干细胞的应用，对于高效的临床转化具有重要意义。近年来，监管机构和科学界已经认识到标准化方面的差距，并开始制定标准来支持干细胞研究和临床转化。在这里，我们讨论了这些标准的发展，这些标准支持将干细胞产品转化为临床治疗，并探讨了正在进行的工作，以定义当前的干细胞指南和标准。我们还介绍了干细胞治疗的一般方面和人类多能干细胞的当前国际共识，讨论了临床级干细胞的标准化，并提出了建立干细胞标准的框架。最后，我们回顾了支持干细胞治疗的国际和中国标准的正在发展情况。
