Advanced BioHealing, Inc. (ABH) announced today that it has enrolled the first patient in its initial Celaderm(TM) pilot study. The study, whose primary purpose is to evaluate the safety of Celaderm in humans, will also assess the potential for Celaderm to accelerate healing of venous leg ulcers compared with optimal standard therapy. The study is designed to enroll 55 patients who will be evaluated throughout a 12-week healing period and then be observed for an additional three months to assess the safety of the product. Separately, ABH announced that it has requested permission from the U.S. Food and Drug Administration (FDA) to add two more clinical sites to facilitate enrollment, bringing the number of clinical sites to eight.
“We are very pleased to officially begin evaluating the safety of Celaderm, our next-generation bioengineered tissue product, in humans,” said David Eisenbud, M.D., Executive Vice President and Chief Medical Officers of Advanced BioHealing. “This marks the first clinical trial with our own internally-developed product, allowing us to expand on our existing product portfolio that currently includes two FDA approved wound healing products. Celaderm utilizes a proprietary cryopreservation technology which we believe will provide doctors and patients with advancement over earlier bioengineered products.”
“When first-generation bioengineered tissue products were introduced, physicians who treat wounds were provided a tremendous option that changed our approach to wound care,” said William Marston, MD, Associate Professor of Surgery, Division of Vascular Surgery at the University of North Carolina at Chapel Hill. “As an investigator in the Celaderm study, I am thrilled to test this next-generation product that could significantly expand the market for advanced wound therapy by being both highly effective and immediately available at the point-of-care.”
Success in this clinical study would allow Celaderm, which is regulated as a medical device, to move directly into a pivotal trial of clinical efficacy and this would culminate in a subsequent PreMarket Approval (PMA) submission. If approved for sale, Celaderm would complement ABH’s current portfolio of approved products: Dermagraft(R) which is approved for diabetic foot ulcers and TransCyte(R) for the treatment of full and partial- thickness burns.