FDA Clears the Way for New Embryonic Stem Cell Trial

Jan 06, 2011   

In what may be a sign that the FDA is loosening its grip on human embryonic stem cell (hESC) research, Advanced Cell Technology (ACT) announced that it has been cleared by the FDA to begin a new round of human clinical trials. The clinical trial will focus on developing a method to treat dry age-related macular degeneration, a condition that largely afflicts people over the age of sixty. According to ACT, previous trials using the therapy on animals have proven promising, showing “. . . a remarkable improvement in visual performance over untreated animals, without any adverse effects.”

With this recent FDA clearance, ACT is now the only company to have multiple hESC trials cleared by the FDA. As we previously reported, the FDA cleared the companys Investigational New Drug (IND) application in November, allowing ACT to begin a related clinical trial to treat a type of juvenile vision loss. In addition to these recently-cleared INDs, the FDA has cleared just one other hESC trial to date. In January 2009, Geron announced that the FDA had given initial clearance to allow the Company to proceed with clinical trials to treat patients with acute spinal cord injuries. While there are currently only three approved hESC clinical trials, these recent clearances may be an indication that the FDA is opening the door for further human embryonic stem cell research.

For more information on the FDA regulatory framework regarding stem cells or the Investigational New Drug process, please contact us at contact@fidjlaw.com.