IND-enabling Epicardial Biopharmaceutical in the Diabetic Heart

NIH RePORTER · NIH · R44 · $1,997,399 · view on reporter.nih.gov ↗

Abstract

ABSTRACT Diabetes mellitus (DM) is caused by inadequate insulin secretion or an inability to respond appropriately to secreted insulin, which leads to chronic elevated blood sugar levels (hyperglycemia). An estimated 171 million people worldwide have DM, and the prevalence of DM will more than double over the next 2 decades. Diabetic patients have increased rates, severity, and complexity of atherosclerotic Coronary Artery Disease and increased likelihood of undergoing surgical revascularization procedures. None of the current coronary revascularization procedures regenerate the myocardium. This project will test the efficacy of a bioabsorbable rhFSTL1*-containing collagen matrix (EpicaPatch), applied to the epicardium overlying the damaged myocardium in infarcted diabetic pigs. Phase 1 is designed to obtain proof of feasibility and, if successful, Phase 2 describes IND enabling studies that would form part of a pre-IND submission to FDA to support a First in Man clinical trial. The benefits of this therapy, if successful are the addition of regenerative capacity to current revascularization procedures, therefore protecting diabetic patients from heart failure.

Key facts

NIH application ID
9789449
Project number
4R44HL140649-02
Recipient
REGENCOR, INC.
Principal Investigator
PILAR RUIZ-LOZANO
Activity code
R44
Funding institute
NIH
Fiscal year
2020
Award amount
$1,997,399
Award type
4N
Project period
2018-08-15 → 2022-01-31