Concise Review: Laying the Groundwork for a First-In-Human Study of an Induced Pluripotent Stem Cell-Based Intervention for Spinal Cord Injury

Osahiko Tsuji, Keiko Sugai, Ryo Yamaguchi, Syoichi Tashiro, Narihito Nagoshi, Jun Kohyama, Tsuyoshi Iida, Toshiki Ohkubo, Go Itakura, Miho Isoda, Munehisa Shinozaki, Kanehiro Fujiyoshi, Yonehiro Kanemura, Shinya Yamanaka, Masaya Nakamura, Hideyuki Okano

Research output: Contribution to journalReview articlepeer-review

27 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)6-13
Number of pages8
JournalStem Cells
Volume37
Issue number1
DOIs
Publication statusPublished - 2019 Jan

Keywords

  • Cell transplantation
  • Clinical trials
  • Induced pluripotent stem cells
  • Spinal cord injury

ASJC Scopus subject areas

  • Molecular Medicine
  • Developmental Biology
  • Cell Biology

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