ArticleStem cell research & therapy2025
A simple and standardized method supports efficient derivation of clinical-grade human embryonic stem cells under feeder- and xeno-free conditions.
Article in Stem cell research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Genomic stability of human pluripotent stem cells: advances in research and screening criteria.Stem cells translational medicine · 2026Review
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16 authors.
Funding
Abstract
backgroundHuman embryonic stem cells (hESCs), as naturally pluripotent stem cells, constitute a pivotal cell source for cell replacement therapies. Yet, the generation of clinically compliant hESC lines under feeder-free and xeno-free conditions remains inefficient. Moreover, the derivation of hESCs from clinically surplus and discarded low-quality embryos using the standardized, translation-ready culture systems has not been reported.
methodsBy optimizing culture conditions and inner cell mass (ICM) isolation method, we developed a method that significantly improves the derivation efficiency of hESC lines from clinically surplus and discarded frozen-thawed embryos under feeder- and xeno-free conditions. The derivation protocol is operationally simple and easily standardized, with the reagents commercially available and of GMP-grade.
resultsUsing this protocol, we successfully established 16 hESC lines. Among blastocysts with morphologically distinct ICMs of grades A and B, the derivation efficiency achieved approximately 60%, with all three grade A ICMs yielding viable hESC lines (100% derivation efficiency for grade A). Notably, for embryos with poorly developed ICMs (grade C), the derivation efficiency of hESC lines approached 30%, showing the protocol's robustness across varying ICM quality. Adhering to GMP standards, we derived two clinical-grade hESC lines, which were demonstrated biological safety, sustained pluripotency, and the capacity for three-germ-layer differentiation.
conclusionsOur study offers a robust, standardized, and simple method for deriving clinical-grade hESCs. Efficient derivation, propagation and banking of hESC lines from frozen-thawed embryos would offer a valuable cell source for advancing regenerative medicine, disease modeling, and drug development.
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