TOKYO -- Japan's health ministry on Monday approved the use of induced pluripotent stem (iPS) cells to treat spinal cord injuries, in what will be the world's first research of its kind.
The special committee of the Ministry of Health, Labor and Welfare approved a clinical research program at Keio University in Tokyo, in which iPS cells will be used to treat spinal cord injuries. The study is expected to start as early as this summer.
Previously, the transplantation of iPS cells was only allowed in treating eyes, hearts, cranial nerves and blood platelets of patients as part of regenerative medicine research.
If the spinal cord is damaged due to injury or accident, it becomes impossible to transmit signals between the brain and the nerves that move the body. As a result, spinal cord injury victims suffer symptoms including paralyzed arms and legs.
In Japan, about 5,000 people sustain such spinal injuries each year, and the cumulative number of victims is more than 100,000. There is no treatment to restore the injured parts completely.
Keio University's treatment plan is reportedly the most important among the regenerative medicine techniques using iPS cells.
Research into the spinal cord is not easy because it is difficult to reproduce the conditions of nerves. Therefore, progress in the development of drugs for the spinal cord has been slow, as has that for brain drugs.
With the advent of iPS cells, there are growing expectations that regenerative medicine techniques complimenting nerve cells might be able to improve motor function in paralyzed patients.
Experimental transplants into monkeys by Keio University professor Hideyuki Okano and others succeeded in restoring motor function so that the animals could walk.
Plans call for the study to be conducted on four patients aged 18 and older who have suffered injuries to their spinal cord and whose sensation and bodily mobility have been completely lost.
The researchers will develop cells that can grow into nerves from iPS cells stored at Kyoto University's Center for iPS Cell Research and Application. Two million of these cells will be transplanted into the injured area of each of the subjects via injection. The research team will be led by Okano and Keio University professor Masaya Nakamura.
The safety and efficacy of the procedure will be checked one year after the procedure, and the patients will undergo rehabilitation to help them regain motor control of their limbs. Immunosuppressant drugs will be used to control transplant rejection.