First clinical trial using iPS cells cleared in Japan

A key panel of the Japanese Ministry of Health, Labor and Welfare has given a conditional green light to clinical research involving induced pluripotent stem (iPS) cells. The research, to be conducted by Masayo Takahashi of the RIKEN Center for Developmental Biology in Kobe, will investigate the use of iPS cells in patients suffering from age-related macular degeneration, a common disease in elderly people that can ultimately lead to loss of vision.

The group plans to create autologous iPS cells using skin cells taken from a small number of patients, and then induce retinal pigment epithelium cells, or RPE cells, from each patient’s iPS cells. The RPE cells will be transplanted into the patients’ retinas in the form of a cell sheet, initially to gauge the safety of the therapy.

The plan will now go two more panels and then to the Minister of Health, Labor and Welfare, who is expected to give his official endorsement. The transplantation, which may begin next year at the earliest, promises to be the first clinical application of iPS cells.