Characterization of Clinical-Grade Stem Cells: Microscopic,
Cellular, Molecular, and Functional Characterization of Stem
Cells and Their Products According to Regulatory Requirements
for FDA Approval

C 2022

Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval

SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Lenka TESAŘOVÁ, Aleš HAMPL, Irena KOUTNÁ et. al.

Basic information

Original name

Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval

Authors

SOURALOVÁ, Tereza (203 Czech Republic, belonging to the institution), Daniela ŘEHÁKOVÁ (203 Czech Republic, belonging to the institution), Lenka TESAŘOVÁ (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

1. vyd. Singapore, Stem Cell Production, p. 185-203, 19 pp. Biomedicine & Life Sciences, 2022

Publisher

Springer, Singapore

Other information

Language

English

Type of outcome

Kapitola resp. kapitoly v odborné knize

Field of Study

10601 Cell biology

Country of publisher

Singapore

Confidentiality degree

není předmětem státního či obchodního tajemství

Publication form

printed version "print"

References:

URL

RIV identification code

RIV/00216224:14110/22:00129662

Organization unit

Faculty of Medicine

ISBN

978-981-16-7588-1

DOI

http://dx.doi.org/10.1007/978-981-16-7589-8_8

Keywords in English

Stem cell production; Stem cell sterility; Stem cell clinical trials; Stem cell bioreactor; cGMP inspection

Abstract

V originále

Stem cells have unique properties that make them an exceptional source for regenerative medicine. Various types of stem cells and their products are used for therapeutic purposes, and they differ in their morphology, molecular markers, and functional characteristics. Nevertheless, to comply with regulatory requirements, strict criteria must be fulfilled. Here, we provide a comprehensive overview of the characterization criteria for human mesenchymal stem cells (hMSCs), human neural stem cells (hNSCs), human pluripotent stem cells (hPSCs), and human hematopoietic stem cells (hHSCs) that constitute the starting material for cell therapy products.

Links

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(CEP code: EF16_013/0001826)

Name: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministry of Education, Youth and Sports of the CR, Priority axis 1: Strengthening capacities for high-quality research

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

SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Lenka TESAŘOVÁ, Aleš HAMPL and Irena KOUTNÁ. Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval. In Firdos Alam Khan. Stem Cell Production. 1st ed. Singapore: Springer, Singapore, 2022, p. 185-203. Biomedicine & Life Sciences. ISBN 978-981-16-7588-1. Available from: https://dx.doi.org/10.1007/978-981-16-7589-8_8.

@inbook{1844110,
   author = {Souralová, Tereza and Řeháková, Daniela and Tesařová, Lenka and Hampl, Aleš and Koutná, Irena},
   address = {Singapore},
   booktitle = {Stem Cell Production},
   doi = {http://dx.doi.org/10.1007/978-981-16-7589-8_8},
   edition = {1},
   editor = {Firdos Alam Khan},
   keywords = {Stem cell production; Stem cell sterility; Stem cell clinical trials; Stem cell bioreactor; cGMP inspection},
   howpublished = {tištěná verze "print"},
   language = {eng},
   location = {Singapore},
   isbn = {978-981-16-7588-1},
   pages = {185-203},
   publisher = {Springer, Singapore},
   title = {Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval},
   url = {https://link.springer.com/book/10.1007/978-981-16-7589-8},
   year = {2022}
}

TY  - CHAP
ID  - 1844110
AU  - Souralová, Tereza - Řeháková, Daniela - Tesařová, Lenka - Hampl, Aleš - Koutná, Irena
PY  - 2022
TI  - Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval
VL  - Biomedicine & Life Sciences
PB  - Springer, Singapore
CY  - Singapore
SN  - 9789811675881
KW  - Stem cell production
KW  - Stem cell sterility
KW  - Stem cell clinical trials
KW  - Stem cell bioreactor
KW  - cGMP inspection
UR  - https://link.springer.com/book/10.1007/978-981-16-7589-8
N2  - Stem cells have unique properties that make them an exceptional source for regenerative medicine. Various types of stem cells and their products are used for therapeutic purposes, and they differ in their morphology, molecular markers, and functional characteristics. Nevertheless, to comply with regulatory requirements, strict criteria must be fulfilled. Here, we provide a comprehensive overview of the characterization criteria for human mesenchymal stem cells (hMSCs), human neural stem cells (hNSCs), human pluripotent stem cells (hPSCs), and human hematopoietic stem cells (hHSCs) that constitute the starting material for cell therapy products.
ER  -

SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Lenka TESAŘOVÁ, Aleš HAMPL and Irena KOUTNÁ. Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval. In Firdos Alam Khan. \textit{Stem Cell Production}. 1st ed. Singapore: Springer, Singapore, 2022, p.~185-203. Biomedicine \&{} Life Sciences. ISBN~978-981-16-7588-1. Available from: https://dx.doi.org/10.1007/978-981-16-7589-8\_{}8.

Detailed Information on Publication Record