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Japan trial to treat spinal cord injuries with stem cells

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Japan has approved a stem-cell treatment for spinal-cord injuries. The event marks the first such therapy for this kind of injury to receive government approval for sale to patients.

AFP, Tokyo :
The health ministry approved Monday 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 sustained injuries 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 School of Medicine.
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 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 some 5,000 people sustain spinal cord damage in Japan, and the number of people living with some sort of spinal cord-related injury is estimated to total over 100,000.
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.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 on Monday.
The team at Tokyo's Keio University has received government approval for a trial using so-called induced Pluripotent Stem (iPS) cells - which have the potential to develop into any cell in the body - to treat patients with serious spinal cord injuries.
The trial, expected to begin later this year, will initially focus on four patients who suffered their injuries just 14 to 28 days beforehand, the university said.
The team will transplant two million iPS cells into the spines of the patients, who will 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," Hideyuki Okano, a professor of physiology, said at a press conference.
"We want to do our best to establish safety and provide the treatment to patients," he added.
The study will 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 paralysed 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.
The research team hopes to test the efficacy and safety of the treatment for chronic injuries as well in the future if they can confirm the safety of the technique through the clinical trial.
The announcement comes after researchers in Kyoto said in November 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 he will be monitored for two years.
The researchers injected 2.4 million iPS cells into the left side of the patient's brain in an operation that took about three hours.
Parkinson's disease is a chronic, degenerative neurological disorder that affects the body's motor system, often causing shaking and other difficulties in movement.
iPS cells are created by stimulating mature, already specialised, cells back into a juvenile state - basically cloning without the need for an embryo.
The cells can be transformed into a range of different types of cells, and their use is a key sector of medical research.

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