@article{oai:tsukuba.repo.nii.ac.jp:02001263, author = {Yamaguchi, Teruhide and Uchida Eriko and Okada, Takashi and Ozawa, Keiya and Onodera, Masafumi and Kume, Akihiro and Shimada, Takashi and 高橋, 智 and TAKAHASHI, Satoru and Tani, Kenzaburo and Nasu, Yasutomo and Mashimo, Tomoji and Mizuguchi, Hiroyuki and Mitani, Kohnosuke and Maki, Kazushige}, issue = {19-20}, journal = {Human Gene Therapy}, month = {Oct}, note = {The development of genome-editing technology could lead to breakthrough gene therapy. Genome editing has made it possible to easily knock out or modify a target gene, while current gene therapy using a virus vector or plasmid hampering modification with respect to gene replacement therapies. Clinical development using these genome-editing tools is progressing rapidly. However, it is also becoming clear that there is a possibility of unintended gene sequence modification or deletion, or the insertion of undesired genes, or the selection of cells with abnormalities in the cancer suppressor gene p53; these unwanted actions are not possible with current gene therapy. The Science Board of the Pharmaceuticals and Medical Devices Agency of Japan has compiled a report on the expected aspects of such genome-editing technology and the risks associated with it. This article summarizes the history of that discussion and compares the key concepts with information provided by other regulatory authorities.}, pages = {1043--1053}, title = {Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan}, volume = {31}, year = {2020}, yomi = {タカハシ, サトル} }