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


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.

Authors Rehakova D, Souralova T, Koutna I
Journal International journal of molecular sciences
Publication Date 2020 Mar 31;21(7)
PubMed 32244538
PubMed Central PMC7177280
DOI 10.3390/ijms21072435

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