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@article{2225865,
author = {Souralová, Tereza and Řeháková, Daniela and Ješeta, Michal and Tesařová, Lenka and Beránek, Jindřich and Ventruba, Pavel and Hampl, Aleš and Koutná, Irena},
article_location = {Basel, Switzerland},
article_number = {20},
doi = {http://dx.doi.org/10.3390/ijms232012500},
keywords = {hESC; clinical grade; cell therapy; clean rooms; pluripotent stem cells},
language = {eng},
issn = {1422-0067},
journal = {International Journal of Molecular Sciences},
note = {Korespondenční autor nereagoval na žádost o doplnění podílu. Podíl doplněn rovnocenně podle počtu participujících HS (dle rozhodnutí vedení PřF).},
title = {The Manufacture of Xeno- and Feeder-Free Clinical-Grade Human Embryonic Stem Cell Lines: First Step for Cell Therapy},
url = {https://www.mdpi.com/1422-0067/23/20/12500},
volume = {23},
year = {2022}
}
TY - JOUR
ID - 2225865
AU - Souralová, Tereza - Řeháková, Daniela - Ješeta, Michal - Tesařová, Lenka - Beránek, Jindřich - Ventruba, Pavel - Hampl, Aleš - Koutná, Irena
PY - 2022
TI - The Manufacture of Xeno- and Feeder-Free Clinical-Grade Human Embryonic Stem Cell Lines: First Step for Cell Therapy
JF - International Journal of Molecular Sciences
VL - 23
IS - 20
SP - 1-15
EP - 1-15
PB - MDPI
SN - 14220067
N1 - Korespondenční autor nereagoval na žádost o doplnění podílu. Podíl doplněn rovnocenně podle počtu participujících HS (dle rozhodnutí vedení PřF).
KW - hESC
KW - clinical grade
KW - cell therapy
KW - clean rooms
KW - pluripotent stem cells
UR - https://www.mdpi.com/1422-0067/23/20/12500
N2 - Human embryonic stem cells (hESCs) are increasingly used in clinical trials as they can change the outcome of treatment for many human diseases. They are used as a starting material for further differentiation into specific cell types and to achieve the desirable result of the cell therapy; thus, the quality of hESCs has to be taken into account. Therefore, current good manufacturing practice (cGMP) has to be implemented in the transport of embryos, derivation of inner cell mass to xeno-free, feeder-free and defined hESC culture, and cell freezing. The in-depth characterization of hESC lines focused on safety, pluripotency, differentiation potential and genetic background has to complement this process. In this paper, we show the derivation of three clinical-grade hESC lines, MUCG01, MUCG02, and MUCG03, following these criteria. We developed and validated the system for the manufacture of xeno-free and feeder-free clinical-grade hESC lines that present high-quality starting material suitable for cell therapy according to cGMP.
ER -
SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Michal JEŠETA, Lenka TESAŘOVÁ, Jindřich BERÁNEK, Pavel VENTRUBA, Aleš HAMPL and Irena KOUTNÁ. The Manufacture of Xeno- and Feeder-Free Clinical-Grade Human Embryonic Stem Cell Lines: First Step for Cell Therapy. \textit{International Journal of Molecular Sciences}. Basel, Switzerland: MDPI, 2022, vol.~23, No~20, p.~1-15. ISSN~1422-0067. Available from: https://dx.doi.org/10.3390/ijms232012500.
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