期刊
STEM CELLS
卷 37, 期 1, 页码 6-13出版社
WILEY
DOI: 10.1002/stem.2926
关键词
Cell transplantation; Clinical trials; Induced pluripotent stem cells; Spinal cord injury
资金
- 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 (AMED) [18bm0204001h0006, 18bk01045h003]
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
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