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5 December 2013 11:26 am ,
Vol. 342 ,
Researchers have been hot on the trail of the elusive Denisovans, a type of ancient human known only by their DNA and...
Thousands of scientists in the Russian Academy of Sciences (RAS) are about to lose their jobs as a result of the...
Dyslexia, a learning disability that hinders reading, hasn't been associated with deficits in vision, hearing, or...
Exotic, elusive, and dangerous, snakes have fascinated humankind for millennia. They can be hard to find, yet their...
Researchers have sequenced and analyzed the first two snake genomes, which represent two evolutionary extremes. The...
Snake venoms are remarkably complex mixtures that can stun or kill prey within minutes. But more and more researchers...
At age 30, Dutch biologist Freek Vonk has built up a respectable career as a snake scientist. But in his home country,...
Since arriving on the island of Guam in the 1940s, the brown tree snake ( Boiga irregularis ) has extirpated native...
- 5 December 2013 11:26 am , Vol. 342 , #6163
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U.K. Approves Europe's First Embryonic Stem Cell Clinical Trial
22 September 2011 11:25 am
A U.S.-based company has received permission to start Europe's first clinical trial involving human embryonic stem (hES) cells. Advanced Cell Technology (ACT), based in Marlborough, Massachusetts, received approval today from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to begin a trial that will treat 12 patients with Stargardt's macular dystrophy. The disease strikes people between the ages of 10 and 20, causing progressive vision loss. There is currently no treatment.
Eye surgeon James Bainbridge of Moorfields Eye Hospital and University College London will lead the U.K. trial. He and his colleagues will inject into patients' eyes retinal pigment epithelial cells that ACT derived from hES cells. In animal models, the cells have been able to stave off or even reverse disease progression. The phase I/II trial will primarily examine the treatment's safety, however.
Robert Lanza, ACT's chief scientific officer, says the trial has essentially the same design as the company's U.S. trial with Stargardt's patients, which received approval last year. The fact that the U.S. Food and Drug Administration had approved the trial, however, did not make it a shoo-in with U.K. authorities, Lanza says. "I thought it was going to sail right through. I was wrong; they were very rigorous."
The new trial is the first one using hES cells to receive approval outside the United States, Lanza says. The company plans to apply for approval for a second U.K. trial for age-related macular degeneration, he adds, which would complement its U.S.-based trial for the same condition. They then plan to wait until the first results are in before starting any additional trials, he says. The first two U.S. patients received the company's cells in July—one patient with Stargardt's disease and one with age-related macular degeneration. The first indications are positive, Lanza says. "We're very pleased with what we see so far."