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The Ministry of Health on Monday approved the first clinical trial in the world in which artificially derived stem cells will be used to treat patients with spinal cord injuries.
A team of researchers from Keio University, who requested the test from the ministry, will inject neuronal cells produced from so-called induced pluripotent stem cells – called iPS cells – to four injured people during their sports activities. or traffic. accidents.
This is the fifth time that the government allows clinical studies using iPS cells. Patients, aged 18 years and older, will undergo the treatment test under the guidance of a team led by Hideyuki Okano, a professor at the Keio University School of Medicine.
"It's been 20 years since I started research on cell treatment. Finally, we can start a clinical trial, "Okano said at a press conference in Tokyo. "We want to do our best to establish safety and provide treatment to patients."
Okano and his team have already managed to allow a paralyzed monkey to follow the same approach.
Patients will have lost their mobility and sensations. The cells will be injected within two to four weeks of the patient's accident, during which time the treatment is considered effective.
The team will observe the effectiveness and safety of the cells for about a year during the patient rehab period.
The cells to be transplanted will be created from iPS cells stored at Kyoto University and will be kept in the freezer.
Shinya Yamanaka, of Kyoto University, won the Nobel Prize in Physiology or Medicine in 2012 for the development of iPS cells, which can be transformed into any type of body tissue and are considered a tool promising for regenerative medicine and drug development.
The main goal of the Keio study is to confirm the safety of neural cells to create. The team will limit to 2 million the number of cells it will transplant, but plans to increase this number to 10 million in the future.
Every year in Japan, about 5,000 people suffer from spinal cord injuries, and the number of people living with some kind of spinal cord injury is estimated at more than 100,000.
People who have already had spinal cord injuries are usually in a chronic phase and will not be eligible for the upcoming clinical trial.
Masaya Nakamura, a professor of orthopedics at Keio and responsible for procedures, said the team wanted to confirm "within two to three years" the safety of treating patients with chronic spinal cord injuries.
On Monday, a panel at the ministry also examined another plan for a clinical trial in which corneas produced from iPS cells will be transplanted to treat eye diseases. The trial was proposed by a research team from the University of Osaka. The committee has not yet made a decision regarding the cornea test, which has allowed for further consideration of future discussions.
Among other clinical tests on iPS cells, the government-funded Riken Institute has conducted the world's first transplant of retinal cells developed from iPS cells on a subject suffering from a disease of the iPS cells. eyes, in 2014.
Kyoto University also began last year a clinical trial using iPS cells to treat Parkinson's disease.
In this test, which took place in October, nerve cells created from iPS cells were transplanted into the brain of a patient some 50 years or so ago.
Parkinson's disease reduces the number of dopamine-producing neurons in the brain and causes hand and foot tremors and stiffness of the body. Although there are treatments to relieve the symptoms, there is currently no cure for the disease.
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