SBIR Phase I: Cure-in-Place Extracellular Matrix Replacement Scaffolds for Wound Healing

Gemstone Biotherapeutics, Llc, Baltimore MD

Investigators

Abstract

This Phase I SBIR project will investigate cure-in-place materials for filling and stabilizing open wounds to promote healing. Chronic wounds represent a significant and debilitating burden to patients, affecting more than 6.5 million people in the US alone. The incidence of chronic wounds is expected to rise with increasing rates of obesity and diabetes, but current treatment options show limited clinical efficacy. To address this unmet need, new materials that stimulate the body's healing mechanisms must be developed. This project will evaluate a promising new material that can be applied to a wound as a liquid and cured to a solid in contact with the wound. This cure-in-place process is expected to promote healing by ensuring intimate contact between the pro-healing material and the wound bed, mechanically stabilizing the wound area, and stimulating the body's healing responses. There are few cure-in-place materials in clinical use, so this project will also generate new fundamental engineering knowledge about these materials and their potential applications in human health. The advanced wound care market is currently valued at more than $8 billion, and it is growing. Therefore, innovative technologies in this space represent significant business opportunities that create economic growth. This project will investigate a novel cure-in-place process for generating a polysaccharide biomaterial that mimics the mechanical and structural properties of native extracellular matrix to stimulate wound healing. The material is generated by curing two aqueous precursor solutions to form a biodegradable, solid, and hydrated polymer matrix. This project will investigate a cure-in-place process by which the precursor solutions will be applied to the wound as liquids and cured in contact with the wound bed. If the extracellular matrix replacement biomaterial can be cured inside of a wound bed, then its pro-healing effects may be amplified due to its ability to fill an irregularly-shaped wound with complete contact with tissue and its capacity to mechanically stabilize the wound bed and stimulate pro-healing biochemistry. The scope of this effort will include developing an optimized formulation for the cure-in-place precursor solution, determining curing conditions for the biomaterial in contact with tissue, evaluating the material properties of the cure-in-place product, and evaluating cure-in-place application and wound healing efficacy in a porcine excisional wound model. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.