Stem Cell Trial Nearly Approved

The first human trial of a treatment using induced pluripotent stem cells has received conditional approval from an institutional review board in Japan.

By | February 15, 2013

WIKIMEDIA, GTANNERMasayo Takahashi of the Center for Developmental Biology in Kobe, Japan, and colleagues are nearly ready to start using their experimental induced pluripotent stem (iPS) cell treatment in a human clinical trial, after receiving conditional approval from the institutional review board (IRB) at the Institute for Biomedical Research and Innovation (IBRI) on Wednesday (February 13)—the condition being the final results of ongoing preclinical safety studies. It will be the first human trial using an iPS cell treatment, Nature reported.

The therapy aims to treat age-related macular degeneration, a degenerative retinal condition that can cause blindness, by removing damaged epithelium and replacing it with new iPS cell-derived epithelium. Having already received IRB approval at her home institution, Takahashi is waiting for one of the last stages of approval—the final  by the health ministry—before the trial can begin. Takahashi and her colleagues hope to begin the trial, which will enroll 6 patients at least 50 years old, by March 2014.


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