The health ministry on Monday approved the world’s first clinical test in which artificially derived stem cells will be used to treat patients with spinal cord injuries.
A team of researchers from Keio University, which filed a request for the test with the ministry, will inject neural cells produced from so-called induced pluripotent stem cells — known as iPS cells — into four people who are injured while playing sports or in traffic accidents.
It is the fifth time the government has authorized clinical studies using iPS cells. The patients, aged 18 or older, will undergo the test treatment under the care of a team led by Hideyuki Okano, a professor at the Keio University School of Medicine.
“It’s been 20 years since I started researching cell treatment. Finally we can start a clinical trial,” Okano said at a news conference in Tokyo. “We want to do our best to establish safety and provide the treatment to patients.”
Okano and his team have already succeeded in enabling a paralyzed monkey to walk again through the same approach.
The patients will have suffered lost mobility and sensation. The cells will be injected within two to four weeks of the patients’ accidents — the period in which the treatment is believed to be effective.
The team will observe the efficacy and safety of the cells for about a year while the patients undergo rehabilitation.
The cells to be transplanted will be created from iPS cells in storage at Kyoto University and will be kept frozen.
Kyoto University’s Shinya Yamanaka won the Nobel Prize in physiology or medicine in 2012 for developing iPS cells, which can grow into any type of body tissue and are seen as a promising tool for regenerative medicine and drug development.
The main purpose of Keio’s study is to confirm the safety of the neural cells to be created. The team will limit the number of cells they will transplant to 2 million but plan to increase that to up to 10 million in the future.
Every year in Japan, around 5,000 people sustain spinal cord damage, and the number of people living with some sort of spinal cord-related injury is estimated to total over 100,000.
People with existing spinal cord injuries are mostly in the chronic phase and, therefore, will not be eligible to the upcoming clinical trial.
But Masaya Nakamura, a Keio professor of orthopedics who is in charge of the procedures, said the team wants to confirm “within two to three years” the safety of the treatment for patients with chronic spinal cord injuries.
On Monday, a panel at the ministry also reviewed another plan for a clinical test in which corneas produced from iPS cells will be transplanted to treat eye diseases. The trial was proposed by an Osaka University research team. The panel did not reach a decision on the cornea trial, leaving further consideration to future discussions.
Among other clinical tests with iPS cells, the government-backed Riken institute conducted the world’s first transplant of retina cells grown from iPS cells to an individual with an eye disease in 2014.
Kyoto University also began a clinical test using iPS cells to treat Parkinson’s disease last year.
In that test, which took place in October, nerve cells created from iPS cells were transplanted into the brain of a patient in his 50s.
Parkinson’s disease reduces dopamine-producing neurons in the brain, and results in tremors in the hands and feet and stiffness in the body. While there are treatments to relieve the symptoms, there is currently no cure for the disease.
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