@article{43328ec679c34b15ad324792107d8b97,
title = "Concise Review: Laying the Groundwork for a First-In-Human Study of an Induced Pluripotent Stem Cell-Based Intervention for Spinal Cord Injury",
abstract = "There have been numerous attempts to develop stem cell transplantation approaches to promote the regeneration of spinal cord injury (SCI). Our multicenter team is currently planning to launch a first-in-human clinical study of an induced pluripotent stem cell (iPSC)-based cell transplant intervention for subacute SCI. This trial was conducted as class I regenerative medicine protocol as provided for under Japan's Act on the Safety of Regenerative Medicine, using neural stem/progenitor cells derived from a clinical-grade, integration-free human “iPSC stock” generated by the Kyoto University Center for iPS Cell Research and Application. In the present article, we describe how we are preparing to initiate this clinical study, including addressing the issues of safety and tumorigenesis as well as practical problems that must be overcome to enable the development of therapeutic interventions for patients with chronic SCI. Stem Cells 2019;37:6–13.",
keywords = "Cell transplantation, Clinical trials, Induced pluripotent stem cells, Spinal cord injury",
author = "Osahiko Tsuji and Keiko Sugai and Ryo Yamaguchi and Syoichi Tashiro and Narihito Nagoshi and Jun Kohyama and Tsuyoshi Iida and Toshiki Ohkubo and Go Itakura and Miho Isoda and Munehisa Shinozaki and Kanehiro Fujiyoshi and Yonehiro Kanemura and Shinya Yamanaka and Masaya Nakamura and Hideyuki Okano",
note = "Funding Information: We thank all of the members of 5S7, Dr. Hideyuki Okano's, Dr. Masaya Nakamura's, and Dr. Shinya Yamanaka's laboratories for their encouragement and generous support. We are grateful to Drs. Akio Iwanami, Satoshi Nori, Yoshiomi Kobayashi, Soraya Nishimura, Tsunehiko Konomi, Morito Takano, Akimasa Yasuda, Masahiro Ozaki, Yuichiro Nishiyama, Soya Kawabata, Kohei Matsubayashi, Shinjiro Kaneko, and Kyoko Miura for their significant contributions to the series of our studies, and to Drs. Francois Renault-Mihara and Shinsuke Shibata for their invaluable scientific and technical advice. We also thank the Center for iPS Cell Research and Application, Kyoto University, for the human iPSC clones, and Osaka National Hospital, National Hospital Organization for the human iPSC-NSPC clones, described in the original works cited in the present paper. This study was supported by the Research Center Network for Realization of Regenerative Medicine (Centers for Clinical Application Research on Specific Disease/Organ); Grant No. [18bm0204001h0006]) and Grant No. [18bk01045h003] from Research Project for Practical Applications of Regenerative Medicine, Japan Agency for Medical Research and Development (AMED). Publisher Copyright: {\textcopyright} 2018 The Authors Stem Cells published by Wiley Periodicals, Inc. on behalf of AlphaMed Press",
year = "2019",
month = jan,
doi = "10.1002/stem.2926",
language = "English",
volume = "37",
pages = "6--13",
journal = "Stem Cells",
issn = "1066-5099",
publisher = "Wiley-Blackwell",
number = "1",
}
