The very first human trials of a treatment using induced pluripotent stem cells (iPS cells) in Japan will begin as early as next year, the government-backed Riken research institute announced on June 12.
Speaking at a meeting of the Japanese Society for Regenerative Medicine in Yokohama, research team leader Masayo Takahashi of the Riken Center for Developmental Biology detailed plans to begin using iPS treatments on patients with a degenerative eye condition. Transplanted iPS cells have not developed into cancer in animal testing, and the clinical trial will go ahead now that it’s confirmed that similar procedures do not pose a threat to human health.
According to the human trials plan, iPS cells will be cultivated to transform into retinal pigment epithelium — pigment-rich cells that nourish the retinal visual cells. The new tissue will then be transplanted into the opposite site of the retina of eyes of patients suffering from age-related macular degeneration (ARMD), a condition striking primarily middle-aged and elderly individuals that can lead to complete loss of vision. ARMD cases in Japan are estimated in the hundreds of thousands. If all goes well, the iPS treatments are expected to slow down the progress of the ARMD, and even partially restore the patients’ sight.
Takahashi and her team have already succeeded in transforming iPS cells made from patients’ skin cells into retinal pigment epithelium and transplanted the tissue into mice. None of the animal subjects developed cancer in the wake of the treatments — a major hurdle in clinical tests using iPS cells, though tissue in eye cells are widely believed highly unlikely to develop into cancer.
Plans for the clinical trial will now go before the ethics board at the Foundation for Biomedical Research and Innovation hospital, right next to the Riken developmental biology center in Kobe. If the trial plan gets the OK from the board and the government, the treatments will be carried out on five ARMD patients at the hospital as early as 2013.