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


The human embryonic stem cell line, KthES11, is derived from a normal healthy blastocyst donated for clinical research. The inner cell mass (ICM) was isolated using mechanical dissection and plated on laminin fragments. 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. Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.

Authors Kawase E, Takada K, Nakatani R, Yamazaki S, Suemori H
Journal Stem cell research
Publication Date 2021 Jul;54:102383
PubMed 34126558
DOI 10.1016/j.scr.2021.102383

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