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FDA approves clinical trial for AMD treatment

The Food and Drug Administration (FDA) has approved a clinial trial which will involve replacing retinal cells with human embryonic stem cell-derived tissues in patients suffering from the dry form of age-related macular degeneration (AMD). Twelve people will receive 50,000 to 200,000 retinal pigment epithelial cells which were taken from human emryonic stem cells. These will replace those that were lost to AMD. The safety of the? cells is what's to be determined in the Phase I/II trial. With the aging of the current population, the incidence of AMD is expected to double over the next 20 years and dry AMD is the leading cause of blindness in people over the age of 55. Dry AMD blurs the vision in the center of the eye and attacks retinal cells. Approximately 10 million Americans are affected.* This treatment is not yet available. Even if it passes Phase I and II trials, it must pass a Phase III trial before being made available to the public.

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