[Present and Future of an iPS Cell Stock for Regenerative Medicine].

Tadaaki Hanatani, Naoko Takasu
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Abstract

A haplobank of induced pluripotent stem cell (iPSC) lines derived from healthy donors with homozygous human leukocyte antigen(HLA), which is called "an iPSC stock", has been under construction in Japan. The iPSC stock is expected to enable HLA matching of a majority of recipients and reduce the risk of trans- plant rejection. Full-scale operations began in FY2013, with the aim of covering 30-50% of the Japanese population by FY2017 and most of the population by FY2022 with the iPSC stock. A novel feeder-free and xeno-free culture system for iPSCs was developed to comply with regulatory safety standards. In 2015, a clinical-grade iPSC line with homozygous HLA of the highest-frequency haplotype was released as a first in the world. Other clinical-grade lines are being generated successively. If all goes to plan, the first clinical research using the iPSC stock will start in 2017. However, many challenges remain to ensuring the future of iPSC stock. In accordance with the progress of the latest research, safety issues regarding iPSC-based cell therapy are being monitored with much interest, and one of the major concerns is tumorigenicity. We have to continue to discuss the extent of genomic abnormalities that would or would not be acceptable in not only iPSC-derived products but also iPSC stock, taking into account the risks and benefits of cell therapy. It is also necessary to demonstrate the clinical efficacy of HLA matching, which is indicated to promote graft survival and reduce immunosuppressive drug use.

[用于再生医学的iPS细胞库的现在和未来]。
日本正在建设一个从具有纯合子人类白细胞抗原(HLA)的健康供体获得的诱导多能干细胞(iPSC)系单倍库,称为“iPSC库”。iPSC库存有望实现大多数受体的HLA匹配,并降低移植排斥的风险。全面运营始于2013财年,目标是到2017财年覆盖30-50%的日本人口,到2022财年覆盖大部分人口。开发了一种新型的无进料和无异种培养系统,用于iPSCs,符合法规安全标准。2015年,世界上首次发布了具有最高频率单倍型纯合子HLA的临床级iPSC系。其他临床级别的产品线也在陆续产生。如果一切按计划进行,首个使用iPSC库存的临床研究将于2017年开始。然而,在确保iPSC种群的未来方面仍然存在许多挑战。根据最新的研究进展,基于ipsc的细胞治疗的安全性问题备受关注,其中一个主要问题是致瘤性。考虑到细胞治疗的风险和益处,我们必须继续讨论在iPSC衍生产品和iPSC库存中可接受或不可接受的基因组异常程度。HLA配型在促进移植物存活、减少免疫抑制药物使用等方面的临床疗效也有待进一步研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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