Bio-scaffold startup Ventrix said today it has safely conducted a first-in-human trial of an injectable hydrogel to repair cardiac tissue in patients who have suffered a heart attack.
The FDA-approved, Phase 1 trial is the first to test a hydrogel made from the natural scaffolding of cardiac muscle tissue, also known as extracellular matrix, or ECM, according to the San Diego-based company.
ECM hydrogels have shown some effectiveness in preclinical studies 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 humans who had suffered a heart attack in the past two to 36 months, Ventrix said.
“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 the University of California 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.”
Researchers from Ventrix, a UCSD spinoff company, reported their findings in today’s issue of the Journal of the American College of Cardiology: Basic to Translational Science. Dr. Jay Traverse at Minneapolis Heart Institute was the lead clinical investigator.
Scar tissue that develops after a heart attack, diminishing muscle function and leading to heart failure. Once injected in damaged cardiac muscle, VentriGel 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, according to the company.
VentriGel is made from porcine cardiac connective tissue, which is stripped of heart muscle cells through a cleansing process. It is then freeze-dried and milled into powder form, and then liquefied into a fluid that can be easily injected into heart muscle in a minimally invasive procedure that does not require surgery. Once it hits body temperature, the liquid turns into a semi-solid, porous gel, according to Ventrix.
The Phase 1 trial evaluated the gel in 15 patients who sustained moderate damage in the left ventricle chamber of the heart following a heart attack. Each patient received up to 18 injections of VentriGel into the damaged region via catheter. Researchers followed the patients for six months after treatment. All patients completed the full follow-up.
Twelve of the 15 patients were men. All 15 were experiencing mild to moderate heart failure following a heart attack. Half had suffered a heart attack within the past year.
Ventrix said it is gearing up for a larger, randomized clinical trial to evaluate how effectively VentriGel can improve cardiac function and quality of life for patients experiencing heart failure.
