The value of human pluripotent stem cells (hPSC) in regenerative medicine has yet to reach its full potential. The road from basic research tool to clinically validated PSC-derived cell therapy products is a long and winding one, leading researchers, clinicians, industry and regulators alike into undiscovered territory. All stakeholders must work together to ensure the development of safe and effective cell therapies. Similarly, utilization of hPSC in meaningful and controlled disease modeling and drug screening applications requires information on the quality and suitability of the applied cell lines. Central to these common goals is the complete documentation of hPSC data, including the ethical provenance of the source material, the hPSC line derivation, culture conditions and genetic constitution of the lines. Data surrounding hPSC is scattered amongst diverse sources, including publications, supplemental data, researcher lab books, accredited lab reports, certificates of analyses and public data repositories. Not all of these data sources are publicly accessible nor associated with metadata nor stored in a standard manner, such that data can be easily found and retrieved. The Human Pluripotent Stem Cell Registry (hPSCreg; https://hpscreg.eu/) was started in 2007 to impart provenance and transparency towards hPSC research by registering and collecting standard properties of hPSC lines. In this chapter, we present a short primer on the history of stem cell-based products, summarize the ethical and regulatory issues introduced in the course of working with hPSC-derived products and their associated data, and finally present the Human Pluripotent Stem Cell Registry as a valuable resource for all stakeholders in therapies and disease modeling based on hPSC-derived cells.

人类多能干细胞（hPSC）在再生医学中的价值尚未充分发挥其潜力。从基础研究工具到临床验证的 PSC 衍生细胞治疗产品的道路是一条漫长而曲折的道路，导致研究人员、临床医生、行业和监管机构进入未被发现的领域。所有利益相关者必须共同努力，确保开发安全有效的细胞疗法。同样，在有意义且受控的疾病建模和药物筛选应用中使用 hPSC 需要有关所应用细胞系的质量和适用性的信息。这些共同目标的核心是 hPSC 数据的完整记录，包括来源材料的伦理来源、hPSC 系的衍生、培养条件和系的遗传构成。 hPSC 相关数据分散在不同来源，包括出版物、补充数据、研究人员实验室书籍、认可的实验室报告、分析证书和公共数据存储库。并非所有这些数据源都是可公开访问的，也不是与元数据关联的，也不是以标准方式存储的，因此可以轻松找到和检索数据。人类多能干细胞登记处 (hPSCreg；https://hpscreg.eu/) 于 2007 年启动，通过注册和收集 hPSC 系的标准特性，为 hPSC 研究提供来源和透明度。在本章中，我们简要介绍了基于干细胞的产品的历史，总结了在使用 hPSC 衍生产品及其相关数据的过程中引入的伦理和监管问题，最后介绍了人类多能干细胞注册表作为基于 hPSC 衍生细胞的治疗和疾病建模领域所有利益相关者的宝贵资源。