April 27, 2012
Stratatech Reports Positive Interim Clinical Results for StrataGraft® Skin Substitute
MADISON, Wis., April 27, 2012 – Stratatech Corp., a leader in regenerative medicine, today announced positive preliminary results from its ongoing clinical trial of StrataGraft®, a universal human skin substitute being developed for the treatment of severe burns. All patients enrolled to date have avoided the need for painful autografting, the standard of care which involves transplanting skin from one part of a patient’s body to the wound site. All seven patients assessed at three months achieved complete wound closure with a single application of StrataGraft®.
The sites treated with StrataGraft also were smoother, more supple and less raised compared to the autograft control sites. StrataGraft is the first skin substitute to achieve this level of potency, efficacy and consistency in the treatment of severe burns. These data were presented today at the American Burn Association 44th Annual Meeting in Seattle WA.
“These remarkable results highlight the great potential of our StrataGraft skin substitute and its promise of making a difference in the lives of severely burned patients,” said Lynn Allen-Hoffmann, Ph.D., Stratatech’s chief executive and chief scientific officer. “The need for new therapeutic options to treat severe second and third degree burns is acute and long standing. We are working diligently to move StrataGraft through the clinical trial process and closer to approval and commercialization.”
The multicenter clinical study is assessing the safety and utility of StrataGraft® skin substitute in the treatment of patients with second degree, deep partial-thickness burns. Each patient received a single treatment of StrataGraft on one burn site and a control autograft on a comparable burn site. This enabled the comparison of StrataGraft® to the standard of care for this type of wound. The study’s first group of 10 patients has been enrolled. None of the burns treated with StrataGraft tissue required autografting by day 28, the study’s primary efficacy endpoint.
Analysis of the healed StrataGraft® sites at three months showed no evidence of residual DNA from the StrataGraft tissue. This indicates that StrataGraft® skin tissue was gradually replaced by the patients’ own cells during the natural wound healing process, an important long-term safety consideration. The study is being conducted in collaboration with the U.S. Department of Defense, Armed Forces Institute of Regenerative Medicine.
There is an urgent need for new treatment options for burns. Severe burns and other major skin trauma are life-threatening injuries that require immediate surgical intervention. Frequently, this involves temporary coverage of the wound site with cadaver skin or synthetic dressings to prevent infection and dehydration because there are no full-thickness skin substitutes commercially available for the treatment of burns. Permanent closure of the wound is generally accomplished through split-thickness skin autografting after the wound bed is sufficiently stable that it will accept the transplanted tissue. Although this regimen is the standard of care for severe burns, the limited availability of and potential for pathogen transmission from cadaver skin, as well as the painful surgery associated with autografting, are serious drawbacks to this approach. The American Burn Association estimates that 1.1 million people suffer burns annually in the United States. Approximately 45,000 patients require hospitalization.
About Stratatech Corporation
Stratatech Corp. is a privately-held regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products for therapeutic and research applications. These products are made using the company’s proprietary NIKS® cells – a human keratinocyte progenitor cell line that faithfully reproduces normal epidermal skin architecture and barrier function. The company is using this progenitor cell line to create a portfolio of therapeutic products to treat severe burns, non-healing ulcers, and other complex skin defects. The company’s flagship product, StrataGraft® tissue, is in human clinical testing for the treatment of severe burns and other traumatic skin loss. The company’s second therapeutic product, ExpressGraft™ antimicrobial tissue, is expected to enter clinical testing in 2013 to treat non-healing diabetic foot ulcers.