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FDA clears clinical trial to use embryonic stem cells to treat dry AMD

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MARLBOROUGH, Mass. — The U.S. Food and Drug Administration has cleared Advanced Cell Technology's investigational new drug application to initiate a phase 1/2 clinical trial using retinal pigment epithelial cells derived from human embryonic stem cells to treat dry age-related macular degeneration, the company announced in a press release.

The multicenter, open-label, prospective phase 1/2 trial will assess the safety and tolerability of retinal pigment epithelial cells after subretinal transplantation among 12 patients with dry AMD. The patients will be enrolled in the study at multiple clinical sites. Advanced Cell Technology is considering the Jules Stein Eye Institute at UCLA and the Ophthalmology Department at Stanford University School of Medicine, as well as other undisclosed locations, as possible sites for the trial, according to the release.

While the preliminary portion of the trial will address safety, subsequent clinical trials will attempt to demonstrate that retinal pigment epithelial cells injected into the retinal space can slow or halt the progression of AMD while potentially restoring some visual acuity, the release said.

This follows Advanced Cell Technology's November 2010 announcement that the FDA had cleared a phase 1/2 clinical trial employing retinal cells derived from human embryonic stem cells for treating Stargardt's macular dystrophy.

"[Advanced Cell Technology] is now the first company to receive FDA clearance for two [human embryonic stem cell] trials and is now a true translational leader in the field of regenerative medicine," Gary Rabin, interim chairman and CEO of Advanced Cell Technology, said in the release. "It marks a major step forward, not just within the stem cell sector, but potentially for modern health care techniques. We plan to proceed into the clinic with both of our [human embryonic stem cell]-based programs as quickly as possible."

Advanced Cell Technology also plans to seek regulatory approval from the European Medicines Agency to begin a clinical program using human embryonic stem cells in Europe.