Concise Review: Laying the Groundwork for a First-In-Human Study of an Induced Pluripotent Stem Cell-Based Intervention for Spinal Cord Injury.
Osahiko TsujiKeiko SugaiRyo YamaguchiSyoichi TashiroNarihito NagoshiJun KohyamaTsuyoshi IidaToshiki OhkuboGo ItakuraMiho IsodaMunehisa ShinozakiKanehiro FujiyoshiYonehiro KanemuraShinya YamanakaMasaya NakamuraHideyuki OkanoPublished in: Stem cells (Dayton, Ohio) (2018)
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.
Keyphrases
- stem cells
- spinal cord injury
- endothelial cells
- induced pluripotent stem cells
- stem cell transplantation
- cell therapy
- randomized controlled trial
- high glucose
- spinal cord
- single cell
- neuropathic pain
- high dose
- pluripotent stem cells
- mental health
- clinical trial
- physical activity
- drug induced
- low dose
- oxidative stress
- phase iii
- quality improvement
- bone marrow