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

MINNEAPOLIS – 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).

 

About Minneapolis Heart Institute Foundation®

The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education. 

 

Scientific Innovation and Research – MHIF is a recognized leader across all specialties of heart and vascular research. Each year, MHIF leads more than 200 research studies with more than 2,200 patients and publishes more than 200 articles to share learnings from research. MHIF research has improved the standard of care for patients around the world, including through the development of protocols like Level One, which continues to significantly improve outcomes and survival for heart attack patients. 

 

Education and Outreach – MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes among health care providers. This commitment extends to patients and caregivers through a number of community health and education events to raise awareness of heart care and research, engaging individuals in their own health. 

 

The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and engages in cutting-edge research initiatives with its physician partners from the Minneapolis Heart Institute® at Abbott Northwestern Hospital and at 38 community sites across Minnesota and western Wisconsin. For more information, please visit mplsheart.org.