SBIR Phase I: Improving the healing of problematic skin wounds with topical application of growth factors derived from choroid plexus.

This Small Business Innovation Research (SBIR) Phase I project will focus on the development of a therapeutic gel containing the full complement of naturally occurring growth factors secreted by the choroid plexus (CP) for use in the active wound care market, including problematic superficial skin wounds such as diabetic ulcers. High doses of single recombinant factors have shown limited value in treating these wounds, with long-term side effects manifesting after cumulative exposure to milligram quantities. The unique technology that CytoSolv has developed employs multiple CP proteins to elicit a synergistic ?cocktail? effect that reduces the cumulative exposure to any one protein, while enhancing the pharmacologic impact by involving multiple regenerative pathways. The broader/commercial impacts of this research extend to tissue regeneration, and CytoSolv has initiated preclinical development to treat diabetic ulcers. These wounds are responsible for the majority of lower extremity amputations in the world, and are among the principal reasons for hospitalization of diabetic patients, accounting for 25% of all admissions in the US. Recently developed biologic therapies have not been widely accepted clinically due to inconsistent evidence of useful efficacy. As a result, the problem of managing complications of diabetic ulcers remains a major source of disability and cost to our health care system, with an active wound care market estimated at $20 billion in the US alone, and more than 115 companies delivering products for 5.7M patients. The goal of the current project is to develop an inexpensive, efficacious therapy based on the CP factor technology.