Second human embryonic stem cell trial cleared by FDA

[JBeukema]

An embryonic stem cell treatment for a rare inherited form of blindness was approved Monday for clinical trials. This is only the second human embryonic stem cell-based trial to be approved by the U.S. Food and Drug Administration (FDA)—the first started last month with a Geron Corp. trial that is assessing the use of such cells to treat spinal cord injuries. The latest trials will examine the effectiveness of embryonic stem cells to treat Stargardt's macular dystrophy, which causes the death of photoreceptor cells in the retinal pigment epithelium, often in early adolescence. Some 30,000 to 50,000 people in the U.S. have the disease, for which there is currently no treatment, according to the American Macular Degeneration Foundation.

Observations: Second human embryonic stem cell trial cleared by FDA