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Japan's health ministry approves pluripotent stem cell research

28 June 2013
Appeared in BioNews 711

A Japanese Health Ministry panel has approved the first use of induced pluripotent stem cells (iPS cells) in human trials.

The Riken Center for Developmental Biology hopes to use iPS cells to treat age-related macular degeneration (AMD), a common cause of blindness in older people. Its small-scale pilot study would test the safety of iPS cells transplanted into patients' eyes.

The trial still requires final approval from Japan's minister of health, labour and welfare but this is likely later this month. Should approval be granted, the study could start before the end of the year.

'No one on Earth has established basic standards for iPS cell treatments', lead researcher Dr Masayo Takahashi told The Mainichi. 'What we're doing will strongly influence world standards for the technology; we'll be making the rules'.

AMD damages pigment epithelium cells in the eye, causing reduced vision leading to blindness. The pilot study will recruit six patients, all at least 50 years old, who have not responded to conventional treatment.

Researchers will reprogram the patient's own skin cells to become iPS cells and then direct them to become pigment epithelium. Damaged epithelium will be removed from the patients' eyes and replaced with a sheet of these new cells. The research team will closely monitor the patients for any complications for four years after the operation.

As the pilot study will focus on safety, it is unlikely the patients will experience significant improvements in their vision. Kanji Takahashi, chief ophthalmologist at Kansai Medical University Hirokata hospital, told AFP: 'The trial is a hope for AMD patients, but it will probably take years before the new treatment will actually contribute to improving the vision of many people'.

Dr Masayo Takahashi also expects a very modest improvement in sight for the initial trial. 'I'd really like people to temper their expectations', she told The Mainichi.

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