Concise Review: Laying the Groundwork for a First-In-Human Study of an Induced Pluripotent Stem Cell-Based Intervention for Spinal Cord Injury-Reference-Cited by-同舟云学术

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

Published:2018-11-12 Issue:1 Volume:37 Page:6-13
ISSN:1066-5099
Container-title:Stem Cells
language:en
Short-container-title:

Author:

Tsuji Osahiko¹^ORCID,Sugai Keiko¹^ORCID,Yamaguchi Ryo¹²³,Tashiro Syoichi⁴,Nagoshi Narihito¹,Kohyama Jun²,Iida Tsuyoshi¹²,Ohkubo Toshiki¹²,Itakura Go¹²,Isoda Miho²³,Shinozaki Munehisa²,Fujiyoshi Kanehiro¹⁵,Kanemura Yonehiro⁶,Yamanaka Shinya⁷,Nakamura Masaya¹,Okano Hideyuki²^ORCID

Affiliation:

1. Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan

2. Department of Physiology, Keio University School of Medicine, Tokyo, Japan

3. Regenerative & Cellular Medicine Office, Sumitomo Dainippon Pharma Co., Ltd., Kobe, Japan

4. Department of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, Japan

5. Department of Orthopaedic Surgery, National Hospital Organization Murayama Medical Center, Tokyo, Japan

6. Department of Biomedical Research and Innovation, Institute for Clinical Research and Department of Neurosurgery, Osaka National Hospital, National Hospital Organization, Osaka, Japan

7. Center for iPS Cell Research and Application (CiRA), Kyoto University, Kyoto, Japan

Abstract

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

Funder

Research Center Network for Realization of Regenerative Medicine

Centers for Clinical Application Research on Specific Disease/Organ

Research Project for Practical Applications of Regenerative Medicine

Japan Agency for Medical Research and Development

Publisher

Oxford University Press (OUP)

Subject

Cell Biology,Developmental Biology,Molecular Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/stem.2926

Reference69 articles.