Stratatech completes clinical trial of skin substitute

Madison, Wis. - Stratatech Corp. has announced the successful completion of a clinical trial of its StrataGraft human skin substitute.

The company, a regenerative medicine company focused on the commercialization of tissue-engineered skin substitutes, said it achieved its primary clinical endpoint for the trial, which is engraftment that is comparable to the standard of care.

The goal of the clinical trial was to evaluate the safety and effectiveness of StrataGraft in patients with major skin trauma that required temporary skin replacement before autografting - the transplantation of skin tissue from one part of a patient's body to another.

During the multi-center, 15-patient trial, Stratatech said no adverse or serious adverse events were associated with exposure to StrataGraft.

The clinical trial data was presented during the annual meeting of the American Association for the Surgery of Trauma. The University of Wisconsin-Madison's Michael J. Schurr was the trial's principal clinical investigator. StrataGraft tissue is a second-generation human skin substitute that exhibits normal human skin structure and function. It is manufactured using the company's human keratinocytes cell technology, which reproduces normal human skin tissue structure and barrier function.

The technology was developed in the UW-Madison laboratory of Lynn Allen-Hoffmann, Stratatech's founder, chief scientific officer, and chief executive.

In a statement released by the company, Allen-Hoffmann said the clinical trial data provides strong support for ongoing product development and commercialization. This includes efforts designed to enhance antimicrobial activity and blood vessel growth at the wound site. “We look forward to discussing these and other product commercialization milestones as we move through the balance of 2008 and into 2009,” she said.