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Riken to apply for approval to conduct iPS clinical research

Kyodo

The government-backed Riken scientific research institute said Thursday it has applied for government permission to conduct clinical research using induced pluripotent stem cells, known as iPS cells, to regenerate retinas.

If the ministry accepts Riken’s plan, it would be the world’s first clinical research using iPS cells, which grow into different kinds of human body tissue.

Riken, whose formal name is the Institute of Physical and Chemical Research, plans to carry out the research at the Foundation for Biomedical Research and Innovation Hospital in Kobe.

Riken, based in Wako, Saitama Prefecture, filed the application with the Health, Labor and Welfare Ministry, which is expected to spend several months examining it, officials said.

Masayo Takahashi, an ophthalmologist who heads the research team on retinal regeneration at the Riken Center for Development Biology, will serve as head of the clinical study, the officials said.

Takahashi’s team will try to develop treatment techniques to cure age-related macular degeneration in the exudative form, a condition that may cause a sudden loss of vision due to retinal damage.

The team plans to extract skin cells from a few patients, create iPS cells from them, develop them into pigment epithelium of the retina, and transplant them to the patients.

A separate team of ophthalmologists at the hospital will extract skin cells from the patients and conduct the transplants.

Riken will cultivate the iPS cells at its facility.

Takahashi told a news conference in Kobe that Riken’s application for government permission is the first step in developing treatment techniques.

Kyoto University professor Shinya Yamanaka has developed iPS cells that can grow into any type of human body tissue. He won the 2012 Nobel Prize in physiology or medicine for his advanced research on iPS cells, which are expected to be applied for regenerative medicine and drug development.

In Kyoto, Yamanaka said he is very happy to know that Riken’s research team filed the application only five years after his own team announced the development of human iPS cells.

Kyoto University’s Center for iPS Cell Research and Application headed by Yamanaka will continue helping Takahashi’s team conduct clinical research.

Through the research, the team will first check whether the transplant of iPS cells can cause problems for patients, the officials said. The iPS cell transplants will be the first in the world involving humans.

Since the clinical research would cover patients on whom existing medicine does not work and who have almost lost their eyesight due to the progress of their disease, the iPS cell transplants will not dramatically improve their eyesight, the officials said.

The next stage of clinical research would be full-fledged tests on patients in the early stages of disease with a view to restoring their eyesight, they said.

Riken plans to commercialize the iPS cell transplant around 2020, they said.