The Manufacture of Xeno- and Feeder-Free Clinical-Grade Human
Embryonic Stem Cell Lines: First Step for Cell Therapy

J 2022

The Manufacture of Xeno- and Feeder-Free Clinical-Grade Human Embryonic Stem Cell Lines: First Step for Cell Therapy

SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Michal JEŠETA, Lenka TESAŘOVÁ, Jindřich BERÁNEK et. al.

Basic information

Original name

The Manufacture of Xeno- and Feeder-Free Clinical-Grade Human Embryonic Stem Cell Lines: First Step for Cell Therapy

Authors

SOURALOVÁ, Tereza (203 Czech Republic, belonging to the institution), Daniela ŘEHÁKOVÁ (203 Czech Republic, belonging to the institution), Michal JEŠETA (203 Czech Republic, belonging to the institution), Lenka TESAŘOVÁ (203 Czech Republic, belonging to the institution), Jindřich BERÁNEK (203 Czech Republic), Pavel VENTRUBA (203 Czech Republic, belonging to the institution), Aleš HAMPL (203 Czech Republic, belonging to the institution) and Irena KOUTNÁ (203 Czech Republic, guarantor, belonging to the institution)

Edition

International Journal of Molecular Sciences, Basel, Switzerland, MDPI, 2022, 1422-0067

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

10608 Biochemistry and molecular biology

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.600

RIV identification code

RIV/00216224:14110/22:00126955

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.3390/ijms232012500

UT WoS

000874331900001

Keywords in English

hESC; clinical grade; cell therapy; clean rooms; pluripotent stem cells

Abstract

V originále

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.

Links

MUNI/A/1398/2021, interní kód MU

Name: Zdroje pro tkáňové inženýrství 12 (Acronym: TissueEng 12)

Investor: Masaryk University

NU22-08-00629, research and development project

Name: Vývoj postupů pro léčbu makulární degenerace sítnice deriváty lidských pluripotentních kmenových buněk

Investor: Ministry of Health of the CR, Subprogram 1 - standard

Citovat

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. 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.

@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.

Detailed Information on Publication Record