A team of Japanese researchers will carry out an unprecedented trial using a kind of stem cell to try to treat debilitating spinal cord injuries, the specialists said yesterday.
The team at Tokyo’s Keio University has received government approval for a trial using induced pluripotent stem (iPS) cells — which have the potential to develop into any cell in the body — to treat people with serious spinal cord injuries.
The trial, expected to begin later this year, will initially focus on four patients who were injured just 14 to 28 days beforehand, the university said.
The team would transplant 2 million iPS cells into the spines of the patients, who would then go through rehabilitation and be monitored for a year.
The strict limitations on the number of participants is necessary because the process is an “unprecedented, world first clinical trial,” the university added.
“It’s been 20 years since I started researching cell treatment. Finally we can start a clinical trial,” physiology professor Hideyuki Okano told a news conference.
“We want to do our best to establish safety and provide the treatment to patients,” he added.
The study is to be carried out on patients aged 18 or older who have completely lost their motor and sensory functions.
There are more than 100,000 patients in Japan who are paralyzed due to spinal cord injuries, but there is no effective treatment.
The primary purpose of the trial is to confirm the safety of the transplanted cells and the method of the transplant, the researchers said.
If they could confirm the safety of the technique through the clinical trial, the researchers hope to test the efficacy and safety of the treatment for chronic injuries as well.
The announcement comes after researchers in Kyoto said in November last year that they had transplanted iPS cells into the brain of a patient in a bid to cure Parkinson’s disease.
The man was stable after the operation and is to be monitored for two years.
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