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PETBioNewsNewsJapanese pluripotent stem cell trial receives ethical approval

BioNews

Japanese pluripotent stem cell trial receives ethical approval

Published 15 February 2013 posted in News and appears in BioNews 693

Author

Rueben Harwood

Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false colour).
CC BY 4.0
Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false-coloured cryogenic scanning electron micrograph).

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

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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