The U.S. Food and Drug Administration cleared Advanced Cell Technology to start clinical trials to see if embryonic stem cells can treat the most common form of macular degeneration.
According to Advanced Cell Technology, it can initiate a Phase I/II clinical trial to treat patients with dry age related macular degeneration (dry AMD), the most common form of the eye problem. No treatments are available today. Dry AMD is a leading cause of blindness in people over 55 and affects 10 million to 15 million Americans.
In a nutshell, doctors will inject retinal cells---created from stem cells---into 12 people participating in the study. Macular degeneration occurs when retinal pigment epithelial (RPE) cells thin. Over time the loss of RPE cells cause vision loss and blindness. Only 50,000 to 200,000 RPE cells are needed to treat each patient.
Advanced Cell Technology said that its study will be designed to determine safety and tolerability of the injected RPE cells. The company said it is considering a few sites for its study including UCLA, Stanford and the Jules Stein Eye Institute.
Advanced Cell Technology is the second company to get the FDA node to start human trials with embryonic stem cells. The FDA in October gave Geron the go-ahead to use embryonic stem cells to treat 10 patients with spinal-cord injuries.