July 9, 2020 – The Minneapolis Heart Institute Foundation (MHIF) 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 or infarct 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. The therapy might be able to help reverse heart failure in patients with infarct tissue.
Jay Traverse, M.D., FACC, FAHA, director of research, and Benjamin Sun, M.D., cardiac surgeon, are both MHIF researchers and co-primary investigators for this study. They will be conducted in partnership with Anthony DeMaria, M.D., the Judith and Jack White Chair in Cardiology and founding director of the Sulpizio Cardiovascular Center at UC San Diego, where the hydrogel was invented by Karen Christman, Ph.D., professor of bioengineering, UC San Diego. The trial is sponsored by Ventrix Inc. 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 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.[1,2]
For more information: mplsheart.org
1. Traverse Publishes First-in-Human Porcine ECM Study Results. Minneapolis Heart Institute Foundation. https://mplsheart.org/2019/09/11/traverse-publishes-first-in-human-porcine-ecm-study-results/. Accessed July 8, 2020.
2. Jay H. Traverse, Timothy D. Henry, Nabil Dib, Amit N. Patel, Carl Pepine, Gary L. Schaer, Jessica A. DeQuach, Adam M. Kinsey, Paul Chamberlin and Karen L. Christman. First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients. JACC: Basic to Translational Science. Volume 4, Issue 6, October 2019.DOI: 10.1016/j.jacbts.2019.07.012.