Japanese and U.S. drug regulators have broadly agreed to unify standards for the approval of induced pluripotent stem cells to treat a retinal disease, sources said.
The agreement was reached by the health ministry and the U.S. Food and Drug Administration late last month when a ministry panel approved clinical research using iPS cells for retinal regeneration to cure age-related macular degeneration.
The standards to be applied to clinical tests of cultivated iPS retinal cells cover animal testing data required prior to transplantation of iPS retinal cells in humans, patient qualifications for clinical testing and how to confirm that transplantation would not cause tumors, the sources said Tuesday.
The Japanese and U.S. regulators will work out the standards by 2015, when clinical tests are expected to commence.
Japan’s state-backed Riken research institute will launch clinical research using iPS cells for retinal regeneration this year.