Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy:
Characterization Strategy

J 2020

Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy

ŘEHÁKOVÁ, Daniela, Tereza SOURALOVÁ and Irena KOUTNÁ

Basic information

Original name

Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy

Authors

ŘEHÁKOVÁ, Daniela (203 Czech Republic, belonging to the institution), Tereza SOURALOVÁ (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, MDPI, 2020, 1422-0067

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

10601 Cell biology

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.923

RIV identification code

RIV/00216224:14110/20:00115472

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.3390/ijms21072435

UT WoS

000535574200177

Keywords in English

hPSCs; human pluripotent stem cells; characterization; hESC; human embryonic stem cells; hiPSC; human induced pluripotent stem cells; clinical; cGMP; cell therapy

Abstract

V originále

Human pluripotent stem cells have the potential to change the way in which human diseases are cured. Clinical-grade human embryonic stem cells and human induced pluripotent stem cells have to be created according to current good manufacturing practices and regulations. Quality and safety must be of the highest importance when humans' lives are at stake. With the rising number of clinical trials, there is a need for a consensus on hPSCs characterization. Here, we summarize mandatory and ' for information only ' characterization methods with release criteria for the establishment of clinical-grade hPSC lines.

Links

LM2018128, research and development project

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Acronym: CZECRIN)

Investor: Ministry of Education, Youth and Sports of the CR

NV18-08-00412, research and development project

Name: Lidské embryonální kmenové buňky pro klinické aplikace: derivace a charakterizace

Investor: Ministry of Health of the CR

Citovat

ŘEHÁKOVÁ, Daniela, Tereza SOURALOVÁ and Irena KOUTNÁ. Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy. International Journal of Molecular Sciences. Basel: MDPI, 2020, vol. 21, No 7, p. 1-14. ISSN 1422-0067. Available from: https://dx.doi.org/10.3390/ijms21072435.

@article{1641416,
   author = {Řeháková, Daniela and Souralová, Tereza and Koutná, Irena},
   article_location = {Basel},
   article_number = {7},
   doi = {http://dx.doi.org/10.3390/ijms21072435},
   keywords = {hPSCs; human pluripotent stem cells; characterization; hESC; human embryonic stem cells; hiPSC; human induced pluripotent stem cells; clinical; cGMP; cell therapy},
   language = {eng},
   issn = {1422-0067},
   journal = {International Journal of Molecular Sciences},
   title = {Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy},
   url = {https://www.mdpi.com/1422-0067/21/7/2435},
   volume = {21},
   year = {2020}
}

TY  - JOUR
ID  - 1641416
AU  - Řeháková, Daniela - Souralová, Tereza - Koutná, Irena
PY  - 2020
TI  - Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy
JF  - International Journal of Molecular Sciences
VL  - 21
IS  - 7
SP  - 1-14
EP  - 1-14
PB  - MDPI
SN  - 14220067
KW  - hPSCs
KW  - human pluripotent stem cells
KW  - characterization
KW  - hESC
KW  - human embryonic stem cells
KW  - hiPSC
KW  - human induced pluripotent stem cells
KW  - clinical
KW  - cGMP
KW  - cell therapy
UR  - https://www.mdpi.com/1422-0067/21/7/2435
L2  - https://www.mdpi.com/1422-0067/21/7/2435
N2  - Human pluripotent stem cells have the potential to change the way in which human diseases are cured. Clinical-grade human embryonic stem cells and human induced pluripotent stem cells have to be created according to current good manufacturing practices and regulations. Quality and safety must be of the highest importance when humans' lives are at stake. With the rising number of clinical trials, there is a need for a consensus on hPSCs characterization. Here, we summarize mandatory and ' for information only ' characterization methods with release criteria for the establishment of clinical-grade hPSC lines.
ER  -

ŘEHÁKOVÁ, Daniela, Tereza SOURALOVÁ and Irena KOUTNÁ. Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy. \textit{International Journal of Molecular Sciences}. Basel: MDPI, 2020, vol.~21, No~7, p.~1-14. ISSN~1422-0067. Available from: https://dx.doi.org/10.3390/ijms21072435.

Detailed Information on Publication Record