Minneapolis Heart Institute Foundation and UC-San Diego Receive FDA Approval of Investigational New Drug Application to Continue Research of Novel Hydrogel for Cardiac Tissue Repair

June 2, 2020 

The Minneapolis Heart Institute Foundation® (MHIF) announced that it is conducting additional research on a novel hydrogel that is designed to repair cardiac tissue. In April 2020, the FDA approved an Investigational New Drug (IND) application to investigate the safety and feasibility of delivering VentriGel via catheter into areas of the heart of patients that cannot be completely revascularized at the time of coronary artery bypass grafting (CABG).

The novel hydrogel is made from the natural scaffolding of porcine cardiac muscle tissue, also known as extracellular matrix, or ECM. Once injected into damaged cardiac muscle, it forms a scaffold that acts as a reparative environment where healthy cells migrate, leading to increases in cardiac muscle, less scar tissue, and improvements in heart function.

Dr. Jay Traverse, cardiologist, and Dr. Benjamin Sun, cardiac surgeon, are both MHIF researchers and co-primary investigators for this study, which will be conducted in partnership with Dr. Anthony DeMaria of the University of California – San Diego, where the hydrogel was invented by Dr. Karen Christman. The trial is sponsored by Ventrix, Inc. (San Diego, CA) with additional funding from Sanford Consortium for Regenerative Medicine and the Frank J. and Eleanor A. Maslowski Charitable Trust.

“In our previous Phase I study of VentriGel, we evaluated the safety and feasibility of the hydrogel in repairing damage and restoring cardiac function in heart failure patients who previously suffered a heart attack,” said Dr. Traverse. “We found that the porcine-derived ECM was safe, with no sign of it being rejected by the patient’s hearts. Through this new research study, we will explore injecting the hydrogel into select CABG patients in the hope it will allow for new cardiac muscle and blood vessel growth in areas where surgeons cannot perform a bypass.”

MHIF was the leading enroller and clinical site for the Phase I VentriGel trial, which was the first-in-human study for the product (https://mplsheart.org/2019/09/11/traverse-publishes-first-in-human-porcine-ecm-study-results/). The findings from that study were published in the September 11, 2019, issue of the Journal of the American College of Cardiology (http://basictranslational.onlinejacc.org/content/4/6/659).