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.

Základní údaje

Originální název

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

Autoři

SOURALOVÁ, Tereza (203 Česká republika, domácí), Daniela ŘEHÁKOVÁ (203 Česká republika, domácí), Lenka TESAŘOVÁ (203 Česká republika, domácí), Aleš HAMPL (203 Česká republika, domácí) a Irena KOUTNÁ (203 Česká republika, garant, domácí)

Vydání

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

Nakladatel

Springer, Singapore

Další údaje

Jazyk

angličtina

Typ výsledku

Kapitola resp. kapitoly v odborné knize

Obor

10601 Cell biology

Stát vydavatele

Singapur

Utajení

není předmětem státního či obchodního tajemství

Forma vydání

tištěná verze "print"

Odkazy

URL

Kód RIV

RIV/00216224:14110/22:00129662

Organizační jednotka

Lékařská fakulta

ISBN

978-981-16-7588-1

DOI

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

Klíčová slova anglicky

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

Štítky

rivok, topvydavatel

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 23. 2. 2024 09:18, Mgr. Marie Šípková, DiS.

Anotace

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.

Návaznosti

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

Název: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií, PO 1 Posilování kapacit pro kvalitní výzkum

NV18-08-00412, projekt VaV

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

Investor: Ministerstvo zdravotnictví ČR, Lidské embryonální kmenové buňky pro klinické aplikace: derivace a charakterizace

Citovat

SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Lenka TESAŘOVÁ, Aleš HAMPL a 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. 1. vyd. Singapore: Springer, Singapore, 2022, s. 185-203. Biomedicine & Life Sciences. ISBN 978-981-16-7588-1. Dostupné z: 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 a 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}. 1. vyd. Singapore: Springer, Singapore, 2022, s.~185-203. Biomedicine \&{} Life Sciences. ISBN~978-981-16-7588-1. Dostupné z: https://dx.doi.org/10.1007/978-981-16-7589-8\_{}8.

Podrobný výpis o publikaci