Division of Intractable Diseases, Korea National Stem Cell Bank, Center for Biomedical Sciences, Korea National Institute of Health, Cheongju, Korea.
Wellcome Sanger Institute, Cambridge, United Kingdom.
Stem Cells. 2019 Sep;37(9):1130-1135. doi: 10.1002/stem.3003. Epub 2019 Aug 6.
This report summarizes the recent activity of the International Stem Cell Banking Initiative held at Harvard Stem Cell Institute, Boston, MA, USA, on June 18, 2017. In this meeting, we aimed to find consensus on ongoing issues of quality control (QC), safety, and efficacy of human pluripotent stem cell banks and their derivative cell therapy products for the global harmonization. In particular, assays for the QC testing such as pluripotency assays test and general QC testing criteria were intensively discussed. Moreover, the recent activities of global stem cell banking centers and the regulatory bodies were briefly summarized to provide an overview on global developments and issues. Stem Cells 2019;37:1130-1135.
本报告总结了 2017 年 6 月 18 日在美国马萨诸塞州波士顿哈佛干细胞研究所举行的国际干细胞库倡议的最新活动。在本次会议上,我们旨在就人类多能干细胞库及其衍生细胞治疗产品的质量控制 (QC)、安全性和有效性的当前问题达成全球协调一致的共识。特别是,对 QC 检测(如多能性检测和一般 QC 检测标准)的检测方法进行了深入讨论。此外,简要总结了全球干细胞库中心和监管机构的最新活动,以提供全球发展和问题的概述。干细胞 2019;37:1130-1135.