Generation of clinical-grade human embryonic stem cell line KthES11 according to Japanese regulations

Stem Cell Research (2021)　doi.org/10.1016/j.scr.2021.102383

Dr. Suemori Team reported the establishment of a clinical-grade human embryonic stem cell line KthES11. KthES11 is the first clinical-grade hESC line according to the Japanese regulation known as the “The Act on the Safety of Regenerative Medicine.” Cell line derivation, its propagation, and storage were performed without feeders in an animal product-free environment according to current Good Manufacturing Practice (cGMP) standards. KthES11 shows a normal karyotype, pluripotent state, and differentiation to the three germ layers. The cell line was further validated for sterility, mycoplasma-free, antibiotic residues, and specific human pathogens.