UK scientists to seek approval for human trials of stem-cell blindness therapy

January 24th, 2009 - 1:16 pm ICT by ANI  

London, January 24 (ANI): British scientists will seek the approval of concerned authorities for beginning human trials of an embryonic stem-cell therapy for the commonest cause of blindness this year.
If they get the green light, their project will be the second of its kind in the world, for American regulators have already cleared the first human trial of the powerful master cells.
Pete Coffey, of University College London, said that that the US decision to approve the trial of a paralysis treatment was bloody good news, as it would open the way for his team to test a similar therapy for age-related macular degeneration (AMD) on patients.
It clearly gives a lot of direction to our regulators. It is a precedent of sorts. Our therapy is now very advanced. We are now into the final stages of preclinical work-up. Were already in discussions with the regulatory authorities in the UK, and the fact that Gerons trial is going forward makes the process, I hope, more achievable. We will be making an application later this year, and I would hope well go into patient trials some time in 2010 or 2011, Times Online quoted him as saying.
Professor Coffey has already used embryonic stem cells to grow a type of eye tissue known as retinal pigment epithelium cells, which are destroyed in AMD, leading ultimately to blindness.
According to him, these have thus far shown promise to reverse the eye damage caused by AMD in animal models.
He and his colleagues are presently finalising the safety data they need before starting human trials.
The trials would also require approval from three bodies, namely, the Human Tissue Authority, the Medicines and Healthcare products Regulatory Agency and the Gene
Therapy Advisory Committee.
The researcher will initially be testing the therapy on patients with the dry form of AMD, which affects 90 per cent of sufferers and is incurable.
It is expected ultimately to be suitable for the less common wet form as well, they say.
However, there are scientists who believe that it is not right to place too much hope in the technology at the moment.
It isnt clear that the mechanism they are targeting is the main cause of paralysis after spinal injury. There is nothing wrong with doing trials, but it is important not to build up expectations too much, Geoff Raisman, of UCL, who is researching an adult stem-cell therapy for spinal cord injuries, and who is unsure whether Gerons approach would work. (ANI)

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