Comparison of the 2021 International Society for Stem Cell Research (ISSCR) guidelines for "laboratory-based human stem cell research, embryo research, and related research activities" and the corresponding Japanese regulations

Hideki Yui; Kaori Muto; Yoshimi Yashiro; Saori Watanabe; Yukitaka Kiya; Ayako Kamisato; Yusuke Inoue; Zentaro Yamagata

doi:10.1016/j.reth.2022.05.002

Comparison of the 2021 International Society for Stem Cell Research (ISSCR) guidelines for "laboratory-based human stem cell research, embryo research, and related research activities" and the corresponding Japanese regulations

Regen Ther. 2022 Jun 3:21:46-51. doi: 10.1016/j.reth.2022.05.002. eCollection 2022 Dec.

Authors

Hideki Yui¹, Kaori Muto², Yoshimi Yashiro³, Saori Watanabe², Yukitaka Kiya², Ayako Kamisato², Yusuke Inoue², Zentaro Yamagata¹

Affiliations

¹ University of Yamanashi, Japan.
² University of Tokyo, Japan.
³ Tokyo Metropolitan Geriatric Medical Center, Japan.

Abstract

This paper presents a comparison of the 2021 guidelines for stem cell research and clinical translation outlined by the International Society for Stem Cell Research (ISSCR) with the current regulations in Japan regarding the performance of such research. This paper provides a convenient English-language summary of the Japanese regulations, and illustrates the difference between the ISSCR guidelines and Japanese regulations regarding the conditions of implementation of study activities using human embryos or stem cells, for researchers outside Japan. The regulations governing the performance of research activities using human embryos or stem cells in Japan are relatively complex and comprise a range of laws and guidelines; the specific rules applied depend on the characteristics of each study. Therefore, even similar research activities may differ in terms of not only the guidelines or laws implemented, but also the procedures required. Such situations may confuse researchers.

Keywords: ESCs, embryonic stem cells; Ethical guidelines; Human embryos; Human stem cells; ISSCR, International Society for Stem Cell Research; International society for stem cell research; Japan; iPSCs, induced pluripotent stem cells.