MADISON, Wis.--()--Stratatech Corp., a leader in regenerative medicine, today announced top-line results from its proof-of-concept clinical trial of StrataGraft®, a universal human skin substitute being developed for the treatment of severe burns. Enrollment of all 20 subjects is now complete and 19 of 20 patients avoided the need for painful autograft surgery and regrafting at their StrataGraft-treated sites. The one subject regrafted by day 28, a primary endpoint, also experienced graft failure at the control autograft site and other non-study sites. Seventeen of the remaining 19 evaluable subjects progressed to complete wound closure by 3 months, the trial’s second primary endpoint; one subject achieved closure after 3 months due to a wound dressing error that temporarily reopened her closed wound which had been 95% closed at 2 months; and wound healing in another subject continues to progress slowly but has not yet reached closure.
“Achieving complete wound closure with a single application of StrataGraft® tissue is truly remarkable. This is the first skin substitute to ever achieve this level of efficacy, potency, and consistency in severe burns”
“Achieving complete wound closure with a single application of StrataGraft® tissue is truly remarkable. This is the first skin substitute to ever achieve this level of efficacy, potency, and consistency in severe burns,” said Lynn Allen-Hoffmann, Ph.D., Stratatech’s chief executive and chief scientific officer. “This product offers burn victims the opportunity to avoid painful and potentially disfiguring autografts. These compelling results validate our technology’s unique potential to treat acute wounds, and we believe increases the probability of also achieving positive clinical outcomes in patients suffering from chronic non-healing ulcers.”
This multicenter clinical study was designed to assess the safety and utility of StrataGraft® skin tissue in the treatment of patients with second degree, deep partial-thickness burns. The study was a direct comparison of StrataGraft® to the standard of care which currently requires the harvest of an autograft from the patient’s uninjured skin for transplantation. Each patient received a single treatment of StrataGraft® on one burn site and a control autograft (skin transplant) on a comparable burn site. Need for autografting was formally evaluated at day 28 and wound closure was formally assessed at 3 months. Subjects will continue to be monitored for a full year. The study was fully enrolled in August 2012. Complete study outcomes will be available in late 2013 and submitted for publication.
In addition to assessing closure, analysis of the StrataGraft® sites at 3 months showed no evidence of residual DNA from the StrataGraft tissue in any of the 20 patients. 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 wounds 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 donor site wounds created during autograft surgery coupled with scarring in many instances, 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 Corp.
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® cell line – a consistent and well-characterized source of human keratinocyte progenitor cells that faithfully reproduces normal epidermal skin architecture and barrier function. The company is using these progenitor cells 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 on track to enter clinical testing in 2013 to treat non-healing diabetic foot ulcers.
For more information about Stratatech, its technology and product pipeline, please visit the company’s website at www.stratatechcorp.com.