Japan OKs test using iPS cells to treat spinal cord injuries
With the approval, a team of researchers from Keio University, which filed a request for the test with the ministry, will start recruiting patients from fall to next winter, Kyodo News reports.
The team will inject neural stem cells produced from so-called induced pluripotent stem cells into four people who sustained injuries while playing sports or in traffic accidents.
"Finally, we are able to carry out a clinical study 20 years after the research began," Hideyuki Okano, a professor who is leading the project at Keio's School of Medicine, said in a press conference in Tokyo. "I'd like to offer a safe treatment to patients as early as possible."
Okano and his team have already succeeded in enabling a paralyzed monkey to walk again through the same approach.
It is the fifth time that the government has authorized clinical studies using iPS cells. The patients, aged 18 or older and to undergo the test treatment administered by the Keio team, will have suffered lost mobility and sensation in their limbs.
The cells will be injected within two to four weeks of the patients' accidents -- a period in which the treatment is believed to be effective.
Then for about one year, while the patients undergo rehabilitation, the team will observe the efficacy and safety of the cells, which will be created from iPS cells in storage at Kyoto University and 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 stem cells. The team will initially limit the number of cells they will transplant to 2 million per patient but plan to increase that to up to 10 million in the future.
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