GEL4MED, INC. — Department of Health and Human Services SBIR Phase I: 200

Description

The goal of this Phase I SBIR proposal is to demonstrate feasibility of a flowable antimicrobial cell delivery vehicle for improving tissue regeneration in clean and pathogen contaminated diabetic wounds Diabetic ulcers are a major burden on public health and the economy as they represent least of the annual $ billion in direct diabetic health care cost in the United States This burden is projected to increase in the near future since it is estimated that the prevalence of diabetes in the US which is currently at could reach up to in adults by Delayed diabetic wound healing complicated by infection is the primary cause of non traumatic lower limb amputations representing cases annually The proposed product will deliver therapeutic cells into diabetic wounds that are at risk for infection by i allowing simple point of care cell encapsulation and application to wound beds ii providing an extracellular cell scaffolding matrix that promotes retention and viability of transplanted cells iii preventing pathogenic contamination through intrinsic broad spectrum antimicrobial activity The proposed product is intended for use by healthcare professionals following surgical wound debridement procedures To establish feasibility for this product we propose the following two specific aims Specific Aim Evaluate gel formulations for their ability to effectively encapsulate therapeutic cells and support cell viability in vivo Milestones Show high viability of therapeutic cells following encapsulation in gels both in vitro and in vivo Specific Aim Demonstrate in vivo efficacy of gels delivering therapeutic cells for promoting improved healing of full thickness clean and pathogen contaminated wounds in diabetic mice Milestones Show accelerated wound healing and improved quality of regenerated tissue at days and In Phase II SBIR studies we will validate the product in a diabetic swine model of wound healing establish GMP manufacturing and execute GLP studies in preparation for an FDA pre submission discussion The proposed product is a flowable antimicrobial cell scaffolding matrix that will deliver therapeutic cells into chronic diabetic wounds which are challenging to treat and prone to infections in order to promote regrowth of patient tissue and wound closure The product is designed to incorporate three beneficial features in one material simple point of care cell encapsulation and wound application support for transplanted cells and resistance to pathogenic colonization This product is intended for intra operative use following surgical wound debridement procedures and it has the potential to mitigate the amputations million infections and deaths associated with poor wound closure and antibiotic resistance annually