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

Daniela Rehakova, Tereza Souralova, Irena Koutna
2020 International Journal of Molecular Sciences  
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
more » ... rmation only′ characterization methods with release criteria for the establishment of clinical-grade hPSC lines.
doi:10.3390/ijms21072435 pmid:32244538 pmcid:PMC7177280 fatcat:ygl4pmrtobgilnd2e5ja5bmkfm