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

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.

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

• Original language: English
• Type of outcome: Article in a journal
• Field of Study: 10601 Cell biology
• Country of publisher: Switzerland
• Confidentiality degree: is not subject to a state or trade secret
• WWW: 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
• Tags: 14110517, podil, rivok
• Tags: International impact, Reviewed

Abstract

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