Keio University, Keio University Hospital
Clinical research on "regenerative medicine using iPS cell-derived neural progenitor cells for subacute stage spinal cord injury" (Start of Research and development approved)
In December 2018 Keio University Hospital submitted its provision plan for research on type-one regenerative medicine to the Minister of Health, Labor and Welfare on the clinical study implementation of "regenerative medicine using iPS cell-derived neural progenitor cells for subacute stage spinal cord injury" that is being conducted by Professor Hideyuki Okano of Keio University School of Medicine, Professor Masaya Nakamura of Orthopedic Surgery School and colleagues at Keio University Hospital.
Regarding this plan, at the Regenerative Medical Evaluation Subcommittee of the Health, Labor and Welfare Ministry of Health, Labor and Welfare, held today (February 18, 2019), approved the start of clinical trials according to provisions of the law on the safety of regenerative medicine conformity regenerative medicine.
In the future, Keio University School of Medicine and Keio University Hospital will proceed with this clinical study with maximum consideration for safety, and as a future plan, will investigate the effectiveness by increasing the number of transplanted cells and as a target disease will consider safety and effectiveness in spinal cord injuries in the "chronic phase" as well as "subacute" phase.
Outline of clinical research
· Subject: Patients with kinesthesia complete paralysis due to subacute stage spinal cord injury (14 to 28 days after injury at the time of transplant)
· Number of target case cases: 4 cases
· Number of transplanted cells: 2 million
· Observation period: 1 year
· Main evaluation issues: safety
Secondary evaluation issue: Efficacy, improvement of motor function and sensory function