对欧洲人类多能干细胞登记处的监管洞察。
Regulatory insight into the European human pluripotent stem cell registry.
作者信息
Kurtz Andreas, Stacey Glyn, Kidane Luam, Seriola Anna, Stachelscheid Harald, Veiga Anna
机构信息
1 Berlin Brandenburg Center for Regenerative Medicine, Charité-Universitätsmedizin Berlin , Berlin, Germany .
出版信息
Stem Cells Dev. 2014 Dec;23 Suppl 1(Suppl 1):51-5. doi: 10.1089/scd.2014.0319.
Abstract
The European pluripotent stem cell registry aims at listing qualified pluripotent stem cell (PSC) lines that are available globally together with relevant information for each cell line. Specific emphasis is being put on documenting ethical procurement of the cells and providing evidence of pluripotency. The report discusses the tasks and challenges for a global PSC registry as an instrument to develop collaboration, to access cells from diverse resources and banks, and to implement standards, and as a means to follow up usage of cells and support adherence to regulatory and scientific standards and transparency for stakeholders.
摘要
欧洲多能干细胞登记处旨在列出全球范围内可用的合格多能干细胞（PSC）系以及每个细胞系的相关信息。特别强调记录细胞的伦理采购情况并提供多能性证据。该报告讨论了全球PSC登记处作为开展合作、获取来自不同资源和库的细胞以及实施标准的工具，以及作为追踪细胞使用情况、支持遵守监管和科学标准并为利益相关者提供透明度的手段所面临的任务和挑战。
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