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Science

iPS clinical research to tackle time, cost hurdles

TOKYO -- The collaboration on clinical research announced Monday by Kyoto University and three other Japanese institutions is aimed at establishing a faster and cheaper method of using induced pluripotent stem cells for transplants while ensuring the safety of one of the most promising medical treatments.

One major advantage of using iPS cells, which can be taken from the patient and grown into necessary tissue, was originally seen as their low risk of rejection. But it takes about a year to develop iPS cells into needed tissues, which may frustrate timely treatment. The process also costs nearly 100 million yen ($931,000).

Many in the field are thus pursuing a practical solution: Storing tissues grown beforehand using iPS cells resistant to immunological rejection.

Kyoto University's Center for iPS Cell Research and Application has been stockpiling such cells, which will be used in the new clinical research.

Last year, Sumitomo Dainippon Pharma received iPS cells from Kyoto University. The company is working to multiply and cryopreserve them for use in clinical trials for Parkinson's disease. The company will also supply the iPS cells to other research projects, including one by Keio University on developing therapies for spinal cord injuries.

Osaka University, another partner in the just announced collaboration, hopes to gain expertise that can be applied to remedies for diseases of the heart and cornea.

Public-private efforts are ongoing in the U.S. and the U.K. for freezing iPS cells and supplying them for regenerative medical treatment. At the same time, many researchers remain cautious about using iPS cells, which can turn cancerous when tissue created from them is transplanted.

Kyoto University professor Shinya Yamanaka, who first succeeded in creating iPS cells about a decade ago, has been steadfast in advocating for yardsticks determining whether a tissue is safe for transplant. Last month, a study team at the Japanese health ministry compiled guidelines on iPS cell safety screenings.

One part of the screening will check for mutations in over 600 genes connected to cancer, which will require equipment that analyzes entire genomes, a process that will cost millions of yen.  

"We will take all possible measures to look into the safety in each case, and we'll give the green light once we've determined they are sound scientifically," said Yamanaka in Monday's news conference. "If there is any concern at all, we will put a stop to it," he added.

In the U.S., there is no binding obligation to run iPS cells through thorough genomic analysis, but labs do provide data for reference. There is also an international movement to create safety standards, which may use Japan as a model.

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