Chronic wounds contribute to lower extremity amputations and in the diabetic population, have a 25% incidence rate. These wounds cost the US ~$25 B per year. Current treatment strategies are implemented after a wound has persisted over 4 weeks and usually rely on some type of skin substitute composed of extracellular matrix components. These efforts produce marginal results (12% increase in closure rates compared with saline dressings alone) and more effective products are needed in the clinic. SOLUTION: ECM Technologies, LLC is a start-up company that seeks to commercialize technology garnered from the study of bacterial-host interactions from the laboratory of Dr. Hook in the Texas A&M Health Science Center. The mission of ECM Technologies is to utilize bacterial proteins to augment current biomaterials. Our licensed technology and the science behind our product development is described below. ?1 and ?1 contribute to wound healing by increasing fibroblast proliferation and adhesion, increasing angiogenesis and migration of endothelial cells, and increasing keratinocyte adhesion and migration all through binding a collagen ligand. To increase the potential for integrin mediated wound closure, we have discovered and characterized a bacterial collagen mimetic protein that allows for the introduction of ?1 and ?1 integrin binding sites and is more thermally stable than collagen type I, termed Designer Collagen. Incorporation of Designer Collagen into poly-ethylene glycol (PEG) hydrogels has provided a network with three dimensional (3D) properties that maintains the cell instructive cues of Designer Collagen, where cells adhere, migrate and proliferate on the otherwise inert PEG material. We seek to commercialize Designer Collagen microspheres for use in chronic wounds. Designer Collagen enables recombinant purification, which offers batch-to-batch consistency and eliminates the need for animal derived materials and PEG-PAE offers a highly tunable system for desired degradation, absorption and mechanical properties. Designer Collagen microspheres constitute a gel-like dressing that will conform to atypical wound shapes and depths while offering immediate protection from potential infection.
Aim 1 : Fabricate a topical bioactive microsphere hydrogel dressing based on Designer Collagen.
Aim 2 : Evaluate the Designer Collagen microspheres in a diabetic mouse model of impaired wound healing. After achieving these aims, we will have established proof-of-concept data for Designer Collagen microspheres for use as a chronic wound dressing. Continuation of this project in a Phase II project is desired to achieve additional animal work, approach the FDA, and to devise a GMP production plan.
Since chronic wounds are common to individuals with diabetes (8.3% of the US population) and costs the US billions each year, effective, inexpensive treatment options are needed. Currently, a 'wait and see' approach is used by clinicians since expensive therapies do not have high wound closure rates offering a 12% increase in comparison to moist dressings alone. ECM Technologies development of a Designer Collagen microsphere dressing, which offers advantages in optimization of wound healing mechanisms, tunable mechanical properties, deposition into amorphous wounds, and immediate barrier protection, is greatly needed in the clinic.
