Donor Recruitment and Eligibility Criteria for HLA-Homozygous iPS Cell Bank in Japan

Human induced pluripotent stem (iPS) cells are pluripotent cells that can be established from somatic cells of any donor if they are made in accordance with a certain procedure. Therefore, iPSC-based cell/tissue transplantation has been regarded as one of the most attractive applications for these cells. Although autologous iPS cell-based cell therapy is preferable to avoid graft rejection, it would be financially prohibitive to generate iPS cells for each individual. Therefore, it is necessary to consider allogeneic transplantation from human leukocyte antigen (HLA)-matched donors. In Japan, we have aimed to establish multiple clinical grade iPS cell lines from donors that are homozygous for three HLA loci: HLA-A, -B, and -DR, in order to establish an iPS cell bank for medical use. These HLA-homozygous iPS cells will be able to be transplanted into recipients heterozygous for the same haplotypes with a reduced risk of rejection. We are currently establishing the general design of the Japanese iPS cell bank for regenerative medicine in Kyoto University. In this chapter, we focus on the donor eligibility criteria and contents of the informed consent for the Clinical iPS Cell Bank of Kyoto (CiBK) project, while discussing the current state of the regulatory framework for iPS cell-based cell therapy and future perspectives on iPS cell banking in Japan.