TOKYO -- Riken, Japan's major natural sciences research institute, will begin this year the first-ever clinical study using induced pluripotent stem cells, known as iPS cells, to treat intractable eye disease. The Nikkei interviewed Tadahisa Kagimoto, president of pharmaceutical venture firm Healios, which is working on retinal regeneration together with Riken, about the future outlook for iPS cell-based regenerative medicine.
Q: What is the advantage of medical treatment using iPS cells?
A: Aging is triggered by the death of cells. But iPS technology can switch the age of cells back to zero. Embryonic stem cells do the same. But ES cells are created from fertilized human eggs, which raises moral questions. There are no such dilemmas with iPS.
Q: Do iPS cells have no weak points?
A: They are brand-new, so not much progress has been made in research and practical application. The risks they carry are still unclear. This is the biggest problem. Presumably, the biggest risk is the possibility of their transformation into tumors.
Healios and Riken are jointly developing cell sheets using iPS to cure "age-related macular degeneration," an intractable eye illness. Healthy pigment epithelium cells we made from iPS in the joint study with Riken is a stable substance. It is highly safe as the cell itself secretes a substance that prevents its transformation into a tumor, we think.
Q: How do you plan to push ahead with the development of the iPS cells going forward?
A: Healios obtained from Riken the right to exclusively develop the iPS cells. After the outcome of the clinical research Riken plans to start this summer is made available, a joint venture between our company and Dainippon Sumitomo Pharma will carry out clinical trials. Then, we will apply to the Ministry of Health, Labor and Welfare for approval of production and sale of the iPS cells. We hope that the ministry will grant us the approval by around 2018, so we would be ahead of global rivals in regenerative medicine using iPS.
Q: How will this change the regenerative medicine landscape?
A: Japan is more than 10 years behind the rest of the world in the practical use of regenerative medicine. But if the country can lead the world in the development of iPS cells, which have a wide range of applications in the area of regenerative medicine, the landscape could dramatically change.
Japan's pharmaceutical affairs law was revised in November to allow authorities to give approval for regenerative medicine products at the world's fastest speed. Given the legal support, it's more likely that Japan will catch up with and overtake other countries in the regenerative medicine field.
Q: Do you plan to commercialize other iPS cells than those for use to cure AMD?
A: Of course. We intend to help people by remedying many diseases in the future.
Q: Could you tell us your company's plan for overseas expansion?
A: Once Japan issues approval for our iPS products, I expect that the U.S. and European countries will also relax regulations on regenerative medicine. Our company plans to start clinical trials in the U.S. before we secure approval in Japan.
-- Interviewed by Daisaku Yamasaki, Nikkei staff writer