Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy
Daniela Řeháková, Tereza Souralová, Irena Koutná
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.
Topics & Concepts
Induced pluripotent stem cellCell therapyStem cellComputational biologyStem-cell therapyCellHuman Induced Pluripotent Stem CellsBiologyCell biologyMedicineEmbryonic stem cellGeneticsGenePluripotent Stem Cells ResearchCRISPR and Genetic Engineering3D Printing in Biomedical Research