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

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is to overcome limitations that prevent effective treatment of wound infections. There is a large potential market for this product as the U.S. spends over $50 billion per year on wound care and current wound care products have a high risk of rejection, scarring, and antibiotic resistance. The proposed novel wound care product will reduce the costs to treat infected wounds and limit the number of medical procedures required to restore tissue function. The product consists of a patented human extracellular matrix (hECM) coupled to a novel antimicrobial peptide (AMP). 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. The hECM has regenerative and anti-inflammatory activity to enhance wound healing and improve treatment outcomes. In addition to creating a transformative product in a global market, achievement 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, combined with a human extracellular matrix (hECM) material. The patented antimicrobial protein (AMP) is designed to bind collagen in the hECM. The combination of hECM and AMP will result in an antimicrobial regenerative matrix that will reduce the incidence of infection and improve wound healing. The objectives of the project are to scale-up hECM and AMP manufacturing processes, establish methods for assessing product characteristics and performance for manufacturing quality assurance and release criteria, and evaluate the shelf-life and in vivo performance of the scaled-up manufactured AMP-hECM product in a clinically relevant infectious wound healing model. The AMP-hECM will be evaluated using biochemical, antimicrobial, mechanical and cell growth performance assays. Scale-up of the bioengineered AMP and hECM will be achieved by optimizing the in vitro manufacturing bioreactor growth parameters and processing methods to improve overall product yield. The anticipated outcome of the project is to have defined the large-scale manufacturing protocols and release criteria for the AMP-hECM product. This milestone will enable the execution of validation production runs, and advance the regulatory and commercialization pathways for the product.