Stratatech Corporation, a regenerative medicine company, has announced 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.
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 US Department of Defense, Armed Forces Institute of Regenerative Medicine.
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.
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 US. Approximately 45,000 patients require hospitalization.
"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, 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."