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.
KeywordsHuman Leukocyte Antigen Human Stem Cell Human Leukocyte Antigen Type Cord Blood Bank Human Leukocyte Antigen Locus
We thank Tomoko Kosaka for donor coordination, Kentaro Azuma, Shinji Asonuma, Naoki Nagata, Rie Kato and Toshihiko Hoshino for the administrative assistance; Shinji Uemoto and Toshio Heike for their work at Kyoto University Hospital; Keisuke Okita, Kazutoshi Takahashi, Masato Nakagawa, Shin Kaneko, and Shin Kawamata for the management of cell processing units and scientific discussions; Shimon Tashiro, Ayako Kamisato, and Kaori Muto for discussions and comments regarding potential ethical and regulatory issues.
Funding for the CiBK is provided by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and the Funding Program for World-Leading Innovative Research and Development on Science and Technology (FIRST Program) of the Japan Society for the Promotion of Science (JSPS).
Shinya Yamanaka is a member without salary of the scientific advisory boards of iPierian, iPS Academia Japan, Megakaryon Corporation, and HEALIOS K. K. Japan.
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