MEASURE: In vivo study for detection of tumorigenic cells contained in cell therapy products

Abstract

Detection of residual tumorigenic cells is important in the development of human cell-based therapeutic products. MEASURE evaluated a method using NOG mice in multiple facilities. iPS cells were transplanted in the abdominal region of mice by single subcutaneous injection and then observed for 20 weeks. As a result of the multisite main studies, calculated 50% Tumor Producing Dose (TPD₅₀) values were between 15 and 100 in both males and females. In conclusion, the results of the multisite studies suggest that the method is useful for detection of undifferentiated iPSCs.