Tuesday, November 30, 2010

ACT seeks human trials of its stem cell-linked eye treatment

By Michelle Lang

Advanced Cell Technology Inc. has filed an Investigational New Drug application with the U.S. Food and Drug Administration for its treatment of Dry Age-Related Macular Degeneration (Dry AMD).

The IND specifically refers to ACT’s efforts to begin a Phase 1/2 study of human embryonic stem cell (hESC) derived retinal pigment epithelial (RPE) cells for treating Dry AMD. According to an ACT report, no treatments for Dry AMD are currently available to treat up to 15 million Americans afflicted with it.

The study will enroll 12 patients total at sites that may include the Jules Stein Eye Institute at UCLA, the Ophthalmology Department at Stanford University School of Medicine and the Edward S. Harness Eye Institute at Columbia University College of Physicians and Surgeons.

ACT received FDA clearance last week to launch a Phase 1/2 clinical trial using hESC to treat Stargardt’s Macular Dystrophy, one of the more common forms of juvenile macular degeneration.

“The hope that stem cell therapies may one day repair and regenerate diseased organs and tissue goes far beyond what can be accomplished with traditional medicine,” said Robert Lanza, chief scientific officer of ACT. “This approval shows an apparent readiness by the FDA to work with researchers to move exciting new stem cell based therapies out of the lab and into the clinic.”