ArticleRegenerative therapy2022
Efficient derivation and banking of clinical-grade human embryonic stem cell lines in accordance with Japanese regulations.
Article in Regenerative therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Genomic stability of human pluripotent stem cells: advances in research and screening criteria.Stem cells translational medicine · 2026Review
- A simple and standardized method supports efficient derivation of clinical-grade human embryonic stem cells under feeder- and xeno-free conditions.Stem cell research & therapy · 2025Article
- Stepwise strategy for generating human trophoblast stem-like cells from embryonic stem cells reveals specific role of TFAP2C in acquiring self-renewability.Scientific reports · 2025Article
- ROR2 expression predicts human induced pluripotent stem cell differentiation into neural stem/progenitor cells and GABAergic neurons.Scientific reports · 2024Article
- Truncated vitronectin with E-cadherin enables the xeno-free derivation of human embryonic stem cells.Scientific reports · 2023Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: We recently established clinical-grade human embryonic stem cell (hESC) line KthES11 in accordance with current good manufacturing practice standards in Japan. Despite this success, the establishment efficiency was very low at 7.1% in the first period. Methods: To establish clinical-grade hESC lines, we used xeno-free chemically defined medium StemFit AK03N with the LM-E8 fragments instead of feeder cells. The protocol was then optimized, especially in the early culture phase. Results: We established five hESC lines (KthES12, KthES13, KthES14, KthES15, and KthES16) with 45.5% efficiency. All five hESC lines showed typical hESC-like morphology, a normal karyotype, pluripotent state, and differentiation potential for all three germ layers. Furthermore, we developed efficient procedures to prepare master cell stocks for clinical-grade hESC lines and an efficient strategy for quality control testing. Conclusions: Our master cell stocks of hESC lines may contribute to therapeutic applications using human pluripotent stem cells in Japan and other countries.
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