Stratatech Successfully Completes Clinical Trial Of StrataGraft® Skin Substitute - Trial's Primary Clinical Endpoint Achieved

Main Category: Dermatology
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 01 Oct 2008 - 4:00 PST

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Stratatech Corp. , a regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products, today announced that it has successfully completed the multi-center, 15-patient clinical trial of its StrataGraft® living human skin substitute. The company achieved its primary clinical endpoint for the trial, autograft engraftment comparable to the standard of care. No adverse or serious adverse events were deemed to be associated with exposure to StrataGraft® skin substitute. The clinical trial data was presented Saturday at the annual meeting of the American Association for the Surgery of Trauma by the University of Wisconsin's Michael J. Schurr, M.D., 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 proprietary NIKS® human keratinocytes, which were discovered in the University of Wisconsin laboratory of Lynn Allen-Hoffmann, Ph.D., the company's founder, chief scientific officer and chief executive. Keratinocytes are the cells that make up approximately 90 percent of the epidermis, the outer layer of human skin. NIKS® cells are a consistent source of pathogen-free, non-tumor-producing, long-lived adult progenitor cells. These cells faithfully reproduce normal human skin tissue architecture and barrier function when cultured appropriately.

The goal of the clinical trial was to evaluate the safety and effectiveness of StrataGraft® skin substitute, compared to cadaver skin, the standard of care, in patients with major skin trauma that required temporary skin replacement before autografting. Autografting is the transplantation of skin tissue from one part of a patient's body to another.

The primary clinical endpoint was autograft engraftment or "take" two weeks after autograft placement. Each half of a patient's wound site was pre-treated with StrataGraft® skin substitute or the standard of care prior to autografting. There was no difference in autograft take between wound sites pre-treated with StrataGraft® skin substitute or the standard of care. Overall, StrataGraft® skin substitute maintained physical integrity following placement, appeared healthy at periodic visual inspections and provided a wound bed suitable for autografting.

The wound sites were evaluated for infection during the trial. There was no difference between the StrataGraft® skin substitute and the standard of care, either in clinical or quantitative assessment of infection. Additional data has been collected from a more detailed laboratory study that specifically measured the StrataGraft® tissue's anti-infective capability. These data, submitted with the clinical trial results for publication in the Journal of Trauma, demonstrate a significant difference in the expression of naturally-occurring antimicrobial agents called host defense peptides in StrataGraft® skin substitute compared to tissue generated from conventional sources.

"We are very pleased with the strength of the data generated by our StrataGraft® skin- substitute clinical trial," Dr. Allen-Hoffmann said. "The clinical trial was a significant undertaking for Stratatech and the company executed it with discipline, efficiency and great dedication. Our clinical trial data provides strong support for Stratatech's ongoing product development and commercialization efforts, including those aimed at providing enhanced antimicrobial activity and blood vessel growth at the wound site through our pipeline of skin substitute products. We look forward to discussing these and other product commercialization milestones as we move through the balance of 2008 and into 2009."

The open-label, randomized, dose-escalation trial was conducted by Dr. Schurr and Dr. Lee Faucher of the Department of Surgery at the University of Wisconsin Hospital and Clinics, and by Dr. Kevin Foster at the Arizona Burn Center, Phoenix. Patient enrollment commenced in January 2007 and the trial was completed in April 2008. It was supported in part by a grant to Stratatech from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and was one of only two such trials in the country supported by the institute.

About Stratatech Corp.

Stratatech Corp. is a Madison, Wis.-based a regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products. The company's valuable product pipeline, based on its patented NIKS® human keratinocytes, is comprised of the next generation of skin substitute products that have numerous advantages over tissue derived by conventional means. NIKS® cells are a consistent source of pathogen-free, non-tumor-producing, long-lived human epidermal progenitor cells that faithfully reproduce normal human skin structure and function. For more information about Stratatech, its technology and product pipeline, please visit the company's website at http://www.stratatechcorp.com.

Stratatech Corp.