Accreditation of Biosafe Clinical-Grade Human Embryonic Stem Cells According to Chinese Regulations


Human embryonic stem cells (hESCs) are promising in regenerative medicine. Although several hESC-based clinical trials are under way, a widely accepted standard of clinical-grade cells remains obscure. To attain a completely xeno-free clinical-grade cell line, the system must be free of xenogenic components, the cells must have a comprehensive set of functions, and good manufacturing practice conditions must be used. In this study, following these criteria, we successfully derived two hESC lines, which were thereby considered "clinical-grade embryonic stem cells". In addition to the primary capacity for pluripotency, these two cell lines were efficiently differentiated into various types of clinical-grade progeny. Importantly, the cells were recognized by the National Institutes for Food and Drug Control of China for further eligible accreditation. These data indicate that we have established completely xeno-free clinical-grade hESC lines and their derivatives, which will be valuable for the foundation of an international standard for clinical-grade cells for therapy. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Authors Gu Q, Wang J, Wang L, Liu ZX, Zhu WW, Tan YQ, Han WF, Wu J, Feng CJ, Fang JH, Liu L, Wang L, Li W, Zhao XY, Hu BY, Hao J, Zhou Q
Journal Stem cell reports
Publication Date 2017 Jul 11;9(1):366-380
PubMed 28506532
PubMed Central PMC5511037
DOI 10.1016/j.stemcr.2017.04.017

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