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Japanese pluripotent stem cell trial receives ethical approval

18 February 2013
Appeared in BioNews 693

What would be the first clinical trial to use induced pluripotent stem (iPS) cells has been granted ethical approval in Japan.

Researchers hope to use iPS cells to treat a common eye condition called age-related macular degeneration (AMD). The study aims to demonstrate the safety of a procedure using the cells. If the trial is approved by the Japanese Health Ministry, it could be underway before March 2014, reports the Nature News blog.

The damage to the eyes that occurs in AMD causes reduced vision, which can lead to blindness if left untreated. Currently there is no cure, although drugs exist that can halt the progression of the disease in a minority of cases.

Dr Masayo Takahashi of the Centre for Developmental Biology in Kobe, Japan, has now received conditional approval for the trial from the review board of the Institute for Biomedical Research and Innovation (IBRI). According to Nature News, the IBRI will also sponsor the trial.

Should the final round of preclinical experiments be successful, six patients over the age of 50 who are not responding to existing drugs would be enrolled.

In the procedure, scientists propose to first generate iPS cells from each patient's cells. They would then use these iPS cells to form epithelial cells, the type of cell that is damaged in AMD. The damaged epithelial layer would then be removed from the patients' eyes and replaced with a sheet made from these new cells.

As the first trial would be to test the safety of the procedure, it is not expected to reverse the eye damage in AMD. Although the researchers would hope for some signs that the treatment is working.
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