From snip, snip to step, step in only a few months.
Advanced BioHealing Inc. launched a Phase III clinical trial of its Dermagraft bio-engineered skin substitute in patients with venous leg ulcers.
The Westport, Conn.-based tissue regeneration company said the Dermagraft is designed to help restore damaged tissue and support the body’s natural healing process. The Food & Drug Administration already cleared the product to treat diabetic foot ulcers; ABH said more than 1,000 wound care and outpatient clinics in the U.S. use it.
U.S. regulators earlier this week gave their go-ahead to the 16-week study, expected to be the largest randomized, controlled clinical study of bioengineered skin replacement yet. The trial aims to enroll more than 400 patients in eight countries. One group of patients will receive weekly Dermagraft applications and four-layer compression dressings, while a control group receives weekly applications of four-layer compression dressings only.
Ulcers are a frequent symptom of diabetes. Poor circulation causes blood to pool in the veins of the legs and feet where it eventually seeps out to damage surrounding tissue. Dermagraft is made with specialty cells harvested from infant foreskins removed during circumcisions. The fibroblast cells, which bind proteins between muscles and connective tissue, are seeded onto bioabsorbable mesh, where they grow to fill in the gaps of the mesh, speeding up the body’s normal healing process.
Participating facilities include Boston Medical Center and Beth Isreael Deaconesss medical center in Massachusetts, as well as five sites in Florida and three each in California and Arizona. Trials also will be conducted in seven other states. The study is scheduled to conclude by May 2010. Funding likely is coming from a $23 million private placement of debt by ABH ealier this year. Overall, the company has raised more than $36 million in equity from investors, including $25.5-million, Series C round nearly three years ago led by Safeguard Scientific Inc., a publicly traded holding company that invests in emerging technology and life-science companies.