# IND-enabling  Epicardial Biopharmaceutical in the Diabetic Heart

> **NIH NIH R44** · REGENCOR, INC. · 2020 · $1,997,399

## 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 organization:** REGENCOR, INC.
- **Principal Investigator:** PILAR RUIZ-LOZANO
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,997,399
- **Award type:** 4N
- **Project period:** 2018-08-15 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9789449

## Citation

> US National Institutes of Health, RePORTER application 9789449, IND-enabling  Epicardial Biopharmaceutical in the Diabetic Heart (4R44HL140649-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9789449. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*