Ventrix, a University of California San Diego spin-off company, has successfully conducted a first-in-human, FDA-approved Phase 1 clinical trial of an injectable hydrogel that aims to repair damage and restore cardiac function in heart failure patients who previously suffered a heart attack.
The trial is the first to test a hydrogel designed to repair cardiac tissue. It is also the first to test a 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 2 to 36 months.
“Although the study was designed to evaluate safety and feasibility and not designed to show whether VentriGel effectively helps improve heart function, we observed some improvements in patients,” said Karen Christman, the paper’s senior author and a professor of bioengineering in the Jacobs School of Engineering and the Institute of Engineering in Medicine at UC San Diego. “For example, patients could walk longer distances. We also observed signs of improving heart function in patients who experienced a heart attack more than one year prior to treatment.”