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  3. International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies

International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies

  • Regen Med. 2023 Mar;18(3):219-227. doi: 10.2217/rme-2022-0207.
Takeshi Watanabe 1,  Satoshi Yasuda 2,  Connie L Chen 3,  Louise Delsing 4,  Mick D Fellows 5,  Gabor Foldes 6 7,  Shinji Kusakawa 2,  Lucilia Pereira Mouriès 3,  Yoji Sato 2
Affiliations

Affiliations

  • 1 Drug Safety Research & Evaluation, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-Chome, Fujisawa, Kanagawa, 251-8555, Japan.
  • 2 Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan.
  • 3 Health & Environmental Sciences Institute, 740 Fifteenth Street NW, Suite 600, Washington, DC 20005, USA.
  • 4 CVRM Safety, Clinical Pharmacology & Safety Science, R&D, AstraZeneca, Pepparedsleden 1, Mölndal, 43150, Sweden.
  • 5 CVRM Safety, Clinical Pharmacology & Safety Science, R&D, AstraZeneca, Darwin Building 310, Milton Science Park, Cambridge, CB4 OWG, UK.
  • 6 National Heart & Lung Institute, Imperial College London, London, W120NN, UK.
  • 7 Current address, BioPharmaceuticals R&D, AstraZeneca, Milstein Building, Granta Park, Cambridge, CB21 6GH, UK.
PMID: 36852420 DOI: 10.2217/rme-2022-0207
Abstract

Aim & methods: The Health and Environmental Sciences Institute Cell Therapy-TRAcking, Circulation & Safety Technical Committee launched 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. Results: All facilities detected colonies of human induced pluripotent stem cells (hiPSCs) when five hiPSCs were spiked into 1 million hiPSC-derived cardiomyocytes. Spiking with a trace amount of hiPSCs revealed that repeatability accounts for the majority of reproducibility while the true positive rate was high. Conclusion: 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.

Keywords

cell therapy products; in vitro assay; multisite study; pluripotent stem cells; tumorigenicity.

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