FDA Clears Stem Cell Trial for Macular Degeneration

(Photos8.com)

Advanced Cell Technology Inc. (ACT), a biotechnology company in Marlborough, Massachusetts, said today that the U.S. Food and Drug Administration (FDA) has cleared its application to test-treat dry age-related macular degeneration using human embryonic stem cells.  Dry age-related macular degeneration (AMD) is the leading cause of vision loss and blindness among Americans who are age 65 and older, with no known cure.

The progress of dry AMD includes a breakdown or thinning of the layer of retinal pigment epithelial (RPE) cells in the patient’s macula, the region at the center of the retina responsible for high acuity vision. Over time, the progressive loss of RPE cells and accompanying loss of photoreceptors can cause severe vision loss and even blindness. The company’s Investigational New Drug application to treat AMD that FDA cleared calls for using RPE cells derived from human embryonic stem cells to replace the lost RPE cells in the patient’s eyes.

ACT plans a phase 1-2 prospective, open-label clinical study to determine the safety and tolerability of RPE cells following sub-retinal transplantation into patients with dry AMD. ACT hopes in subsequent clinical trials to demonstrate that RPE cells injected into the retinal space will be capable of slowing or halting progression of the disease, and potentially even restoring some visual acuity to patients.

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