IND-enablingEpicardial Biopharmaceutical in the Diabetic Heart

ABSTRACT Diabetes mellitusDMis caused by inadequate insulin secretion or an inability to respond appropriately to secreted insulinwhich leads to chronic elevated blood sugar levelshyperglycemiaAn estimatedmillion people worldwide have DMand the prevalence of DM will more than double over the nextdecadesDiabetic patients have increased ratesseverityand complexity of atherosclerotic Coronary Artery Disease and increased likelihood of undergoing surgical revascularization proceduresNone of the current coronary revascularization procedures regenerate the myocardiumThis project will test the efficacy of a bioabsorbable rhFSTLcontaining collagen matrixEpicaPatchapplied to the epicardium overlying the damaged myocardium in infarcted diabetic pigsPhaseis designed to obtain proof of feasibility andif successfulPhasedescribes IND enabling studies that would form part of a pre IND submission to FDA to support a First in Man clinical trialThe benefits of this therapyif successful are the addition of regenerative capacity to current revascularization procedurestherefore protecting diabetic patients from heart failureNARRATIVE Diabetic patients have increased ratesseverityand complexity of atherosclerotic Coronary Artery DiseaseCADandof diabetic patients die as a result of a cardiovascular causeThese patients undergo revascularization by coronary artery bypass graftsCABGrather than percutaneous coronary interventionHoweverCABG does not regenerate the myocardiumThis proposal will generate feasibilityPhaseand proof of conceptPhasefor cardiac regeneration in the diabeticinfarcted animal using a bioresorbable collagen matrix containing bacterial made human Follistatin likeThis matrixwhen applied to the epicardial surface overlying the infarct in non diabetic animalsregenerates the myocardiumNatureSeptemberThe goal is to add myocardial regeneration to the established revascularization benefits of CABG in the diabetic patient with ischemic heart diseaseSuch a demonstrationif confirmed in subsequent clinical trialsmight very greatly improve the treatment of ischemic heat disease in diabetes