Third hESC Trial Gets FDA Nod
And now there are 3 FDA-approved clinical trials for human embryonic stem cells (hESCs).
Yesterday Advanced Cell Technology announced that it received the agency's nod to begin an hESC trial in 12 patients with dry age-related macular degeneration (AMD), the most common form of the eye disease. The company's hESC-derived retinal pigment epithelial cells (RPE), which will be injected into the retinal space of affected patients, will be assessed for safety first and efficacy second in the initial phase 1/2 study.
In November, a similar trial was approved by the FDA for Advanced Cell Technology's RPEs in an inherited form of macular degeneration, Stardgardt's disease, which affects about 30,000 Americans. (Dry AMD, however, is much more prevalent—affecting 10-15 million Americans.) Since the announcement of the company's hESC trial in November, its penny-stock value has more than quadrupled.
Last July, the FDA lifted its regulatory hold on Geron's clinical trial program for hESC-derived oligodendrocytes in subacute spinal-cord injury.
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
