Introduction of MEASURE (Multisite Evaluation study on Analytical methods for non-clinical Safety assessment of hUman-derived REgenerative Medical Products）and its collaboration with global stakeholders

Abstract

Since 2016, NIHS has been working with the Committee for Non-Clinical safety Evaluation of Pluripotent stem cell-derived producT, the Forum for Innovative Regenerative Medicine (FIRM-CoNCEPT) on MEASURE (Multisite Evaluation study on Analytical method for non-clinical Safety assessment of hUman-derived REgenerative medical products). In MEASURE project, we conducted multisite validation of test methods for the assessment of tumorigenicity and biodistribution of CTPs. We have also been discussing the global consensus of tumorigenicity assessment of CTPs with international stakeholders.