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.
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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
Original language English
Type of outcome Chapter(s) of a specialized book
Field of Study 10601 Cell biology
Country of publisher Singapore
Confidentiality degree is not subject to a state or trade secret
Publication form printed version "print"
WWW 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
Tags rivok, topvydavatel
Tags International impact, Reviewed
Changed by Changed by: Mgr. Marie Šípková, DiS., učo 437722. Changed: 23/2/2024 09:18.
Abstract
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 projectName: Lidské embryonální kmenové buňky pro klinické aplikace: derivace a charakterizace
Investor: Ministry of Health of the CR
PrintDisplayed: 29/7/2024 18:26