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iPS cell research and the drive for cures(3) -All 4 episodes-

Prof. Shinya Yamanaka

Disease-specific iPS cells are stored in tubes in a liquid-nitrogen tank

Disease-specific iPS cells are stored
in tubes in a liquid-nitrogen tank

iPS cell banking

Interviewer :
In order for clinical applications to be achieved, it's going to be necessary to have an iPS cells bank, isn't it?

Yamanaka :
Yes. In the U.S., an FDA-approved clinical trial using oligodendrocytes derived from human ES cells in the treatment of spinal cord injury is about to begin. It's thought that in order for this therapy to have a chance of being effective, treatment should be delivered 7 to 10 days after the injury. But it takes one to two months to make autologous iPS cells, and about the same amount of time to complete differentiation, so they clearly wouldn't be ready in time in this case. As an alternative, we think it would make sense to create iPS cells from healthy people and keep them in storage in a cell bank.

One problem is that if a transplant is derived from another person's cells, there's the risk of rejection by the immune system. This risk can be minimized by matching donors and recipients by their HLA(human leukocyte antigen) types. It would be a major undertaking to try to bank cells with every possible type, but fortunately there are HLA types that are something equivalent to type O in human blood. If we generate 50 types of iPS cells derived from individuals homozygous for the HLA types most common in the Japanese population , we should be able to cover 90% of the population. Thinking about it in those terms, we will be able to design an iPS cell bank at a reasonable scale.

One advantage of an iPS cell bank is that safety of the cells can be carefully examined in advance. It would take much time and costs to take tissues from patients, culture them and generate iPS cells. There would be little time to check if the patient-specific iPS cells are safe. So in addition to doing R&D into using patients' own cells therapeutically, I think it makes sense to develop a bank of allogeneic iPS cells as well.

Developing guidelines for the benefit of patients

Prof. Shinya Yamanaka

Interviewer :
It seems that in the guidelines on the clinical research using human stem cells to be revised by the Ministry of Health, Labor and Welfare (MHLW) that allogeneic transplants are not authorized.

Yamanaka :
The MHLW guidelines were open to public comment until June 4, 2010. I submitted a comment indicating my strong opposition to the guidelines in their current version, and explaining the usefulness of allogeneic transplantation. This doesn't mean that I am recommending the allogeneic approach alone, only that we have to prepare for the use of both autologous and allogeneic transplantations, comparing the merits of each for patients.

ES cells are generated by destroying a fertilized human embryo, which means that they are non-autologous by definition. So transplants using cells derived from ES cells must be considered allogeneic, which poses ethical issues.
I suppose that the MHLW had an expectation that if the clinical research using iPS cells was confined to work with autologous cells, it would be able to avoid the ethical issues that have beset ES cell research. And they wanted to separate "autologous" and "allogeneic" iPS cells in the same terms as were used for distinguishing iPS cells and ES cells.
But the ethics of allogeneic iPS cells are completely different from those of ES cells. I can't emphasize that enough.

Interview by Miwako Homma, supervisor of iPS Trend website, and Katsuaki Sato and Bisei Watanabe from the Japan Science and Technology Agency.

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Shinya Yamanaka, M.D., Ph.D.

Director, Center for iPS cell Research and Application (CiRA), Kyoto University Senior Investigator, Gladstone Institute of Cardiovascular Disease

After graduating from the Kobe University School of Medicine in 1987, and doing his residency at National Osaka Hospital, Yamanaka received his Ph.D. in medical science from Osaka City University Graduate School of Medicine in 1993. He moved to the Gladstone Institute of Cardiovascular Disease in San Francisco that same year as a postdoctoral fellow. He became a Japan Society for the Promotion of Science special postdoctoral fellow in 1996, and an assistant professor in the department of pharmacology at Osaka City University the same year. He moved to the Nara Institute of Science and Technology as associate professor in 1999 and was appointed professor in 2003. He took a professorship at the Institute for Frontier Medical Sciences, Kyoto University in 2004, moving to the Institute for Integrated Cell-Material Sciences (iCeMS) at the same university in 2007, and named director of CiRA,iCeMS Kyoto University in 2008. He is the director of CiRA, Kyoto University since April 2010.

Major Awards

2004 Tokyo Techno Forum 21 Gold Medal (Japan)
2008 Robert-Koch Prize (Germany)
2008 Shaw Prize in Life Science and Medicine (Hong Kong)
2008 Medal of Honor with Purple Ribbon 2008 (Japan)
2009 Canada Gairdner Foundation International Award (Canada)
2009 Albert Lasker Basic Medical Research Award (U.S.)
2010 Imperial Prize of the Japan Academy (Japan)
2012 The Nobel Prize in Physiology or Medicine


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