Clinical trial using iPS cells for spinal injuries approved

The Health, Labor and Welfare Ministry’s assessment committee on regenerative medicine approved Feb. 18 a clinical trial by Keio University’s team to transplant human induced pluripotent stem (iPS) cells into patients with spinal cord injuries.

The team, which is led by professors Hideyuki Okano and Masaya Nakamura, plans to conduct the first transplant as early as this autumn. It would be the first time iPS cells are used to treat spinal cord injuries.

Spinal cord injuries occur when spinal nerves connecting the brain and the rest of the body are damaged, causing limb numbness.

The research will be conducted on four patients aged 18 or older who have suffered serious spinal cord injuries within two to four weeks of the trial and whose motor and sensory functions are completely paralyzed.

The cells to be transplanted will be developed from donor iPS cells stored at Kyoto University. The transplant is expected to regenerate damaged nerves and improve paralyzed functions.

Immunosuppressors will be used after the transplants to prevent cell rejection. Patients will undergo rehabilitation and receive medication while researchers spend about a year examining the safety and effectiveness of the treatment.

In the field of regenerative medicine using iPS cells, transplants on humans have been conducted in Japan for the treatment of intractable diseases, including age-related macular degeneration, which affects the eyes, and Parkinson’s disease. Clinical application of iPS cell transplants in the treatment of heart disease and cancer is being planned.

At the meeting, the committee discussed research being planned by Osaka University to create corneal cells from human iPS cells to be transplanted into patients with eye diseases. However, discussions are expected to continue before a decision is made.

About 5,000 patients suffer spinal cord injuries every year due to traffic accidents, falls or sports injuries, and more than 100,000 patients suffer chronically for more than six months after being injured.