Monday, November 22, 2010

Another clinical trial using embryonic stem cells is approved by the FDA

According to a press release by Advanced Cell Technology, the Food and Drug Administration has approved another clinical trial using cells which were created from human embryonic stem cells. The company plans to enroll 12 patients with Stargardt's Macular Dystrophy in a early phase clinical trial to test the safety of injecting retinal cells created from human embryonic stem cells into their eyes.

In a LifeNews.com article, Dr. David Prentice comments on the experiment.
"Few details are available at this point, although Robert Lanza, ACT's chief scientist, has said that this series of experiments could begin after the first of the year," he said. "[The study] will include up to 12 patients and will test the safety of injecting cells into one of the patient's eyes, with increasing doses of cells on successive patients. He also hopes to see some results within six weeks of injecting a patient's eye."

Prentice said the embryonic stem cell derivatives are not necessarily safe for patients.

"Of course, one big concern regarding safety is the distinct possibility of tumor formation by embryonic stem cells, since that is their real forte," he said. "No details are available on whether ACT did large animal studies, purity of their experimental cell preparation, or how well the cells retain differentiation versus growing."


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