MHIF is proud to have been the leading enroller and clinical site in the first-in-human, FDA-approved Phase 1 clinical trial of an injectable hydrogel that was evaluated for safety and feasibility in repairing damage and restoring cardiac function in heart failure patients who previously suffered a heart attack, sponsored by Ventrix, Inc. (San Diego, CA).
The trial is the first-of-its-kind to test this novel hydrogel derived from pig hearts designed to repair cardiac tissue. It is also the first hydrogel made from the natural scaffolding of cardiac muscle tissue, also known as extracellular matrix, or ECM. This is significant because ECM hydrogels have been shown in preclinical studies to potentially be effective for other conditions, such as poor blood circulation due to peripheral artery disease. The trial showed that the hydrogel, known as VentriGel, can be safely injected via catheter into patients who had suffered a heart attack in the past 3 years. VentriGel, invented by Dr. Karen Christman at University of California San Diego, is made from porcine cardiac connective tissue.
“We have learned that your heart requires an intact ECM to act as a scaffold to support cardiac muscle cells and blood vessels. Following a heart attack the ECM is destroyed along with the cardiac muscle cells. Implanting the ECM back in the heart will potentially allow for new cardiac muscle and blood vessel growth,” said Jay Traverse, MD, cardiologist at Minneapolis Heart Institute® and Director of Research at Minneapolis Heart Institute Foundation who was the lead investigator in the trial. “Importantly, the porcine-derived ECM was safe with no sign of it being rejected by the patient’s hearts
MHIF enrolled one-third of the total patients of the study. Dr. Traverse is also the lead author of the published findings from the study in the September 11 issue of the Journal of the American College of Cardiology.
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