First trial of embryonic stem cell treatment in Europe gets green light

jackalope

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Jan 2010
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First trial of embryonic stem cell treatment in Europe gets green light
Patients in Britain with an eye disease that leads to blindness will take part in Europe's first human embryonic stem cell trial


British surgeons are to take part in the first trial in patients of a human embryonic stem cell therapy to gain approval from regulators in Europe.

Surgeons at Moorfields Eye Hospital in London will inject cells into the eyes of 12 patients with an incurable eye disease called Stargardt's macular dystrophy, one of the main causes of blindness in young people.


The clinical trial, designed to investigate the safety and tolerance of the groundbreaking therapy, is due to begin in December having received approval from the UK's Medicines and Healthcare products Regulatory Agency on Thursday. It is the first trial in people of a stem cell therapy to receive the go ahead from regulators in any European country.


Medical teams hope to slow, halt or even reverse the effects of the disease by injecting healthy retinal cells into the eye. The trial is controversial because the replacement retinal cells – known as RPE, or retinal pigment epithelial cells – are derived from human embryonic stem cells.


The Massachusetts-based company Advanced Cell Technology (ACT)announced the trial on Thursday. It will run alongside a similar study that began in July at the Jules Stein Eye Institute at the University of California, Los Angeles.


Only one patient has been treated so far in the US trial for Stargardt's disease. The results from both studies are expected next year.

(snip ... )

If the treatment works, the replacement RPE cells will grow and eventually restore the retina to a healthy state that can support light-sensitive cells required for sight.

"This is a safety and tolerability study, so we are dealing with patients with advanced stage disease. Where we expect to get the most significant results is in earlier patients, before they have lost their photoreceptors. We're hoping to prevent the onset of blindness altogether in those patients," Robert Lanza, ACT's chief scientific officer, told the Guardian.

(snip ... )

Last year, the US company Geron began a long-awaited trial of a stem-cell therapy to repair spinal cord injuries. Doctors hope that injecting stem cells directly into the spine will repair damaged nerve cells enough for paralysed people to regain some movement.

First trial of embryonic stem cell treatment in Europe gets green light | Science | The Guardian



I wish them the best of luck, hope there's good news from the trial.


 

Djinn

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I wish them the best of luck, hope there's good news from the trial. [/FONT]
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Agreed, but it saddens me that one day, the U.S. will have to pay other countries for this sort of technology, when we should be developing it ourselves, and having them pay us.
 
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Nov 2010
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Agreed, but it saddens me that one day, the U.S. will have to pay other countries for this sort of technology, when we should be developing it ourselves, and having them pay us.
it is a US company who's doing the trials. What's sad is that they have to send the millions of dollars in money that goes into clinical trials overseas. Instead of conducting trials here because of political pressure on FDA (usually based on ignorance of the process of the general public) they have gotten overly burdensome, its hard to get approval of new drugs and approval times are taking too long. THis is causing companies to do the trials overseas, where they are less restrictive. Especially with stem cells and gene therapy. Those have the promises to actually "cure" diseases for life, by replacing defective cells or defective genes or proteins