HESI’s Cell Therapy-TRAcking, Circulation & Safety Technical Committee completed an international, multisite study to evaluate the sensitivity and reproducibility of the highly efficient culture (HEC) assay, an in vitro assay to detect residual undifferentiated human pluripotent stem cells (hPSCs) in cell therapy products. The results indicate that the HEC assay is highly sensitive and robust and can be generally applicable for tumorigenicity evaluation of hPSC-derived cell therapy products. Read the full article below.
International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies. Watanabe et al. Regenerative Medicine. (27 February 2023) https://doi.org/10.2217/rme-2022-0207.