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

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 a

SUBMITTER: Gu Q 

PROVIDER: S-EPMC5511037 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature