Evaluation of genome instability and safety of cell therapy products

Abstract

A risk of tumor formation due to emergence of transformed cells is one of the safety risks specific to cell therapy products. Increased genetic instability is a potential hazard for the tumor formation risk. However, there is no global consensus on the clinical safety of cells with genetic mutations. Although a couple of MHLW guidance documents raise several test methods for the evaluation of genetic instability, these tests are generally intended to be carried out to obtain reference information about the characteristics of cells rather than shipping criteria.