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

Stem Cell Reports
Qi GuQi Zhou

Abstract

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.

Citations

Jul 22, 2018·Neural Regeneration Research·Chang-Geng SongHua Han
Oct 25, 2020·Biologicals : Journal of the International Association of Biological Standardization·Jiaqi Lu, Wei Wei
Dec 21, 2020·Stem Cell Research·Lei WangJie Hao
Mar 2, 2021·Frontiers in Cell and Developmental Biology·Yuxiao ZengHaiwei Xu
Nov 2, 2021·Stem Cells Translational Medicine·Jiani CaoTongbiao Zhao

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Methods Mentioned

BETA
flow-cytometry
dissection
nuclear magnetic resonance
flow cytometry
Assay

Software Mentioned

FlowJo

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