NANOFIBER SOLUTIONS LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Project SummaryIn this Phase I SBIR projectSynthetic Resorbable AV Graftwe propose a new paradigm in vascular grafts and patient treatment with the development of a novelfully syntheticAV graft with off the shelf availabilityThis unique interdisciplinary project combines the tissue engineering and surgical experience of DrNarutoshi Hibino in the Cardiac Surgery Department at Johns Hopkins University HospitalBaltimoreMDand the clinically proven expertise of synthetic nanofiber scaffolds from DrJed Johnson at Nanofiber SolutionsHilliardOHThrough this innovative product development collaborationwe hypothesize that our fully resorbablesynthetic nanofibervascular graft will result in dramatically improved patient care by eliminating risk of immune rejectiongraft infectionand providing a graft that remodels into a fully functional neovessel with no foreign material remaining in the bodyAccording to the American Society of Nephrologymore thanAmericans have end stage renal diseaseESRDand are dependent on artificial dialysis to stay aliveArteriovenousAVfistulae are commonly constructed to create vascular access for hemodialysisHoweveraccess failure is currently one of the leading causes of hospitalization for patients with ESRDInfection and early thrombosis of non resorbable synthetic grafts such as those made from expanded polytetrafluoroethyleneePTFEand polyethylene terephthalateDacronprevent these procedures from having better success ratesA solution for vascular access and other vascular diseases may be provided by biodegradablenanofiber tissue engineered vascular graftsTEVGsA carotid artery to jugular vein AV graft implantation in a sheep modelNat amonth time pointwill be used in this study since we already have extensive mouseratand low pressurei e venous circulationsheep dataWith this projectwe will accomplish our proposed specific aimsInvestigate key mechanical properties of our AV scaffold throughout complete degradation using an in vitro degradation chamber per ASTMandEvaluate the safety and efficacy of our AV scaffold in a sheep model formonths NarrativeIn this workwe will develop fully syntheticbioresorbablearteriovenous grafts utilizing electrospun nanofibers for vascular access in patients undergoing hemodialysisThese tissue engineered vascular grafts will address limitations with currently available commercial products such as high infection risk and high rate of thrombosis