2019/03/08

Approval of Clinical Research into Regenerative Medicine Using iPS Cell-Derived Neural Stem / Progenitor Cells to Treat Subacute Spinal Cord Injuries

In December 2018, Keio University Hospital submitted a provisional plan for class I regenerative medicine to the Minister of Health, Labour and Welfare detailing the application of clinical research for regenerative medicine using human iPS cell-derived neural stem / progenitor cells (hiPSC-NS/PCs) to treat subacute spinal cord injuries, which is to be led by Keio University professors Hideyuki Okano, of the Department of Physiology, and Masaya Nakamura, of the Department of Orthopedic Surgery.

At the Ministry of Health, Labour and Welfare’s Subcommittee for Regenerative Medicine of the Health Sciences Council, held on February 18, 2019, this clinical research received approval that this plan meets conformity assessment criteria for the provision of regenerative medicine as stipulated in the Act on the Safety of Regenerative Medicine.

Keio University School of Medicine and Keio University Hospital can now proceed with this clinical research while giving the utmost consideration to safety, and in the future, we hope to propose a plan that will allow us to study how to effectively increase the number of transplantable cells as well as the safety and efficacy of treatments for not just subacute but also chronic spinal cord injuries.

Summary of Research Plan （Status: Not yet recruiting）
< Objectives >
Primary objective : Safety
Secondary objective : Effectiveness

< Cell processing facilities >
Kyoto University, Keio University, Osaka National Hospital

< Location >
Keio University Hospital (Tokyo, Japan)


< Estimated Enrollment >
4 participants

< Criteria >
Inclusion criteria (summary):

  • Complete spinal cord injury (AIS Impairment scale A)

  • Less than 24 days within injury

  • 18 years or older

Exclusion criteria (summary):

  • Multiple injury, or transection injury, or rupture of dura mater is apparent on MRI of spinal cord.

  • History of previous spinal cord injury, or diseases related to spinal cord or subarachnoid space.

  • Severe respiratory failure, or damage to other organs which make it difficult to comply with rehabilitation or assessment of the neurological function.


< Observation period >
1 year