There could a new form of treatment in Japan for spinal cord injuries if a newly-approved clinical trial hits the mark.
On Monday, a special committee of the Ministry of Health, Labor and Welfare in Japan approved a clinical research program at Tokyo’s Keio University to use induced pluripotent stem (iPS) cells to treat spinal cord injuries. According to the Nikkei Asian Review, this is a groundbreaking first-of-its-kind study. The clinical trial is expected to begin this summer.
Until this particular trial, the use of induced pluripotent stem cells had only been allowed in treating, eyes, hearts, cranial nerves and blood platelets of patients as part of regenerative medicine research, the Nikkei Asian Review, reported.
According to the report, four patients over the age of 18 will receive the experimental treatment. Each of these patients has suffered an injury to the spinal cord. As a result of those injuries, each of the four patients has lost sensation and mobility in their bodies. The trial will attempt to take the induced pluripotent stem cells and grow them into nerve cells. The Japanese research team will transplant two million of these new nerve cells into the injured areas of each patient via injection in hopes of inducing a response. The patients will also be given immunosuppressant drugs to prevent rejection of the transplanted cells.
If the trial is a success, it could provide significant hope for individuals who have lost mobility and sensation following an injury to the spinal cord. In Japan, the Nikkei Asian Review reported that there are about 5,000 such injuries each year. The total number of people in that country with these kinds of injuries is more than 100,000.
The process to use iPS has been slow. As the Nikkei Asian Review reported, it is difficult for researchers to reproduce the conditions of the nerves in the spine. But, with iPS, there are “growing expectations” that this kind of treatment will prove successful and improve motor functions in these patients. When the experimental treatment was used in primates, researchers were successful in restoring motor function.
Following the procedure, the Nikkei Asian Review said the safety and efficacy of the experiment will be checked within a year, particularly as there is a risk that the transplanted cells could become cancerous. Patients will undergo physical rehabilitation to assist them in regaining the use and control of their limbs. The physical rehabilitation process is expected to last about six months.
By Alex Keown, BioSpace