Open AccessConcise Review: Laying the Groundwork for a First‐In‐Human Study of an Induced Pluripotent Stem Cell‐Based Intervention for Spinal Cord Injury
Author(s) -
Tsuji Osahiko,
Sugai Keiko,
Yamaguchi Ryo,
Tashiro Syoichi,
Nagoshi Narihito,
Kohyama Jun,
Iida Tsuyoshi,
Ohkubo Toshiki,
Itakura Go,
Isoda Miho,
Shinozaki Munehisa,
Fujiyoshi Kanehiro,
Kanemura Yonehiro,
Yamanaka Shinya,
Nakamura Masaya,
Okano Hideyuki
Publication year - 2019
Publication title -
stem cells
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.159
H-Index - 229
eISSN - 1549-4918
pISSN - 1066-5099
DOI - 10.1002/stem.2926
Subject(s) - induced pluripotent stem cell , spinal cord injury , regenerative medicine , stem cell , biology , transplantation , regeneration (biology) , neuroscience , bioinformatics , spinal cord , embryonic stem cell , medicine , surgery , microbiology and biotechnology , biochemistry , gene
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