Posted April 11, 2016
B. Lynn Allen-Hoffman, Ph.D.; Stratatech Corporation, Madison, WI.

Combat-related trauma and blast injuries frequently result in skin loss and infection caused by contaminating foreign material in exposed wounds. The Military has an interest in providing effective, readily available treatments to enhance wound healing, replace skin, and decrease infection and contamination by multidrug-resistant (MDR) wound pathogens. Current skin substitutes on the market are designed to replace or compensate for nonfunctioning skin; however, none have been optimized to address the other major challenges in the management of traumatic wounds: direct reduction of microbial infection and enhancement of the immune response to combat the infection. In 2011, Dr. B. Lynn Allen-Hoffmann of Stratatech Corporation (Madison, WI) received a Defense Medical Research and Development Program/Military Infectious Diseases Research Program (DMRDP/MIDRP) award for preclinical studies to test the ability of a novel antimicrobial skin tissue, ExpressGraft-C9T1, to promote wound healing and prevent infection in combat-related wounds. ExpressGraft-C9T1 tissue is composed of a biodegradable matrix and human skin cells expressing the antimicrobial host defense peptide cathelicidin.

As we learn more about bacteria that are increasingly evolving into MDR organisms, there is a rising need for alternative approaches to combat these organisms. Oral or systemic antibiotics that can be used to treat these infections are often times accompanied by undesirable side effects. Dr. Allen-Hoffmann’s group used animal models to show that their anti-infective skin replacement product was effective in the reduction of bacterial infection in wounds while otherwise non-toxic to the host animal. ExpressGraft-C9T1 tissue is considered a regenerative medicine product because of its ability to replace lost skin tissue, immediately restoring key functions such as water loss prevention, while simultaneously promoting healing and tissue restoration by the patient’s own skin. Data generated from this project supported an Investigational New Drug (IND) application to the Food and Drug Administration in April 2015, enabling initiation of a Phase I clinical safety trial of the antimicrobial tissue in the treatment of skin wounds in humans that is anticipated to begin later this year. The DMRDP-funded project will now focus on optimizing the anti-infective skin substitute for increased production and optimal shelf life for use in the aforementioned clinical trial and, potentially, for future commercialization.

Other government organizations have shown interest in Stratatech’s efforts for development of novel skin replacement products. The company has recently received a large multi-million dollar contract with the Biomedical Advanced Research and Development Authority (BARDA; under the U.S. Department of Health and Human Services) to further develop their first skin replacement product, called StrataGraft® tissue, and supply it to the government in preparation for potential future radiological or nuclear threats to the public that could cause extensive skin damage. The Armed Forces Institute of Regenerative Medicine (AFIRM) has also funded further development of StrataGraft, with a now successfully completed Phase II clinical trial of StrataGraft supporting use of this product to treat deep partial-thickness skin wounds. StrataGraft has been determined to be Phase III ready by the FDA. If proven safe and effective, StrataGraft skin tissue and ExpressGraft-C9T1 tissue could have a transformational effect on combat casualty care by advancing treatment of US military service members and veterans recovering from combat-related wounds.

Links:

Public and Technical Abstracts: Biologically Active Advanced Antimicrobial Human Skin Substitute for the Treatment of Combat Wounds

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