July 30 (UPI) -- The first human trial using a form of stem cells to treat Parkinson's disease will begin this week, a university in Japan announced Monday.
Koyoto University's Center for iPS Cell Research and Application received approval from the Pharmaceutical and Medical Devices Agency, which is the Japanese equivalent of the U.S. Federal Drug Administration, on June 4. The trial was announced in a press release and news conference.
Starting Wednesday, researchers plan to inject 5 million induced pluripotent stem cells into patients' mid-brains at Koyoto Hospital in Tokyo. A 12-milimeter diameter hole will be drilled on the patient's skull and cells will be injected using a specialized device with a needle.
The iPS cells, which will come from healthy donors, will be developed into dopamine-producing brain cells, which are no longer present in people with Parkinson's disease. They also will be evaluated for the use of Tacrolimus, an immunosuppressant commonly used in organ transplation.
Seven participants aged between 50 and 69 will participate in the trial and their progress will be monitored for two years.
Last August, a lab run by Jun Takahashi found that monkeys with Parkinson's disease symptoms had significant improvement over two years after being transplanted neurons prepared from human iPS cells.
"Our research has shown that DA neurons made from iPS cells are just as good as DA neurons made from fetal midbrain," he said last year in a press release. "Because iPS cells are easy to obtain, we can standardize them to only use the best iPS cells for therapy."
They found the quality of the cells was more important than the quantity.
In Parkinson's disease, the dopaminergic neurons cells degenerate, resulting in decreased dopamine production. Animal studies had shown that "transplanted progenitor cells will differentiate into mature dopaminergic neurons, resulting in efficient engraftment in the brain," according to the release.
Parkinson's disease, a chronic, degenerative neurological disorder, affects the body's motor system, causing people to shake and have difficulty with movements.
About 10 million people have the illness, including 1 million in the United States, according to the Parkinson's Disease Foundation.