STTR Phase I: A novel wound dressing for infection control and tissue regeneration

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to overcome limitations that prevent effective treatment of major wound infections. The U.S. spends over $50 billion per year on wound care; thus there is a large potential market for this product. Current wound care products have a high risk of rejection, scarring, and antibiotic resistance. This will be a novel wound care product to reduce the costs to treat infected wounds and limit the number of operations required to restore tissue function. The product consists of a patented human ECM, loaded with a novel anti-infective protein. The main innovation of the proposed product compared to current treatments is that it is designed to be toxic to infective bacteria and other pathogens, without harming human tissue. Furthermore, the human cell-produced material has regenerative and anti-inflammatory activity, may enhance wound healing and improve treatment outcomes. In addition to creating a transformative product in a global market, achievement and assessment of AMP extracellular matrix tethering will lead to a broader understanding of AMP activity and unlock their commercial utility. The product can be used as a temporary wound dressing, a tissue restoring implant, or an implant coating. The proposed project will utilize a patented recombinant protein with an antimicrobial peptide (cathelicidin-LL37) and a collagen binding domain, combined with a human extracellular matrix (ECM) material. The patented protein is designed to bind collagen in the ECM, and tether the antimicrobial peptide to the material. The research objectives are to improve yield, scalability and purification of antimicrobial protein production, validate the antimicrobial and collagen binding activities of the protein in vitro, measure antimicrobial peptide binding within the ECM material in vitro, and, importantly, to test the efficacy of the antimicrobial peptide-ECM product in vivo. Two in vivo models are proposed; 1) a chick chorioallantoic membrane contaminated with bacteria will be used to test antimicrobial activity, and 2) the material will be implanted in mice to assess its pro-regenerative and anti-inflammatory activity. We anticipate that the antimicrobial peptide will bind to the ECM material, and materials with antimicrobial peptide will exhibit decreased bacterial contamination in vitro and in vivo. The Phase I project team will develop and validate systems for larger scale manufacturing and quality testing of the product in preparation for large animal and human clinical trials.