SAPPORO – Sapporo Medical University said Friday that it will launch the nation’s first clinical trial for using stem cells to regenerate nerves in people with spinal cord injuries.
A team including professors Toshihiko Yamashita and Osamu Honmo will solicit about 30 examinees for the trial, which will last until October 2016.
The team will collect bone marrow fluid from patients who have sustained spinal cord injuries within the past two weeks, extract mesenchymal stem cells that develop into nerves from the fluid, and cultivate them in large quantities to make a preparation that will be intravenously injected into the patients.
The chances of rejection are low, because the patients’ own cells will be used and the physical strain from intravenous injection is limited, the team said.
The examinees must be between 20 and 64 years old and meet other conditions to participate in the trial, including having their main injury in the cervical cord.
In Japan, there are about 5,000 spinal cord injuries each year, causing loss of motor function or sensory paralysis, but no effective therapy has been developed yet, Yamashita said.
If the experimental stem cell therapy successfully regenerates damaged nerves, the examinees might regain the use of their hands or legs again.
Yamashita and Honmo told a press conference that lasting effects from the method have been confirmed in basic research using mice.
In the coming trial, the cell preparation made from the mesenchymal stem cells will be injected into patients within 54 days of their spinal injury, they said.
Yamashita said the team hopes to finish the clinical trial as early as possible but added that there is no timeline for putting the therapy into practical use.
Last year, Sapporo Medical University launched a similar trial aimed at reducing the suffering of stroke patients.
Another approach to treating spinal cord injuries is to use induced pluripotent stem (iPS) cells for nerve regeneration.
A team including Keio University and Dainippon Sumitomo Pharma Co. plans to start an iPS cell-based clinical research project in 2017 as part of a science ministry program for promoting regenerative medicine.