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FDA Approves Stem Cell Treatment Trial for AMD-Related Vision Loss


The US Food and Drug Administration (FDA) has approved a clinical trial of human embryonic stem-cell treatments on patients who have suffered vision loss related to dry age-related macular degeneration (AMD). Advanced Cell Technology of Massachusetts will begin a Phase I/II open-label study on twelve patients at multiple clinical sites to determine the safety and tolerability of the treatment.

Dry AMD is a Leading Cause of Blindness in Older Adults

Dry age-related macular degeneration is one of two forms of an eye disease that breaks down retinal pigment epithelial (RPE) cells in the macula of the retina, a layer of light-sensitive tissue at the back of the eye. Progressive loss of RPE cells and the accompanying loss of photoreceptors can cause severe vision loss. There are no current treatments available for AMD.

Dry AMD is the leading cause of blindness in individuals over the age of 55, afflicting approximately 10 million people in the US. And as the population ages, states Robert Lanza MD, ACT’s Chief Scientific Officer, “the incidence of AMD is expected to double over the next 20 years.”

Read: Vitamin Drug Could Stop Dry Macular Degeneration

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In the approved experiments, patients will receive 50,000 to 2,000,000 RPE cells derived from human embryonic stem cells to replace those lost due to AMD. While human embryonic stem cell use is controversial, ACT maintains that their cells are derived from a single-cell extraction technology that “does not destroy the embryo.”

The company has already performed experiments of stem cell transplants in animal subjects and “we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects,” says Lanza in an ACT press release.

Read: Smoking Raises Risk of Macular Degeneration

Another ACT trial to test RPE stem cells was approved by the FDA for patients with Stargardt’s Disease in November. Stargardt’s is a form of juvenile macular degeneration.

Sites currently under consideration for the trials include the Jules Stein Eye Institute at UCLA and the Ophthalmology Department at Stanford University. Other information about the trials will be publishes shortly at http://clinicaltrials.gov.