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

Authors

ŘEHÁKOVÁ Daniela SOURALOVÁ Tereza KOUTNÁ Irena

Year of publication 2020
Type Article in Periodical
Magazine / Source International Journal of Molecular Sciences
MU Faculty or unit

Faculty of Medicine

Citation
Web https://www.mdpi.com/1422-0067/21/7/2435
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
Description 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.
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