Ventrix, a spin-off from the University of California at San Diego, has successfully completed an FDA-approved, Phase 1 clinical trial of an injectable hydrogel to repair lesions and restore heart function in patients with heart failure patients who have already suffered a heart attack.
The test is the first to test a hydrogel designed to repair heart tissue. It is also the first to test a hydrogel made from a natural scaffold of cardiac muscle tissue, also known as extracellular matrix, or ECM. This is significant because preclinical studies have demonstrated that ECM hydrogels are potentially effective against 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 a catheter to patients who have had a heart attack in the last 2 to 36 months.
"Although the study was designed to assess safety and feasibility, and not to show whether VentriGel is effective in improving cardiac function, we have seen some improvements in patients," said Karen Christman, lead author of the study. journal and professor of bioengineering at the Jacobs School of Engineering and the San Diego UC Medical Engineering Institute. "For example, patients could travel longer distances, we also observed signs of improvement in heart function in patients who had a heart attack more than a year before treatment."
Ventrix researchers, led by Christman, report their findings in the September 11 issue of Journal of the American College of Cardiology: From Basic Science to Translation. Dr. Jay Traverse of the Minneapolis Heart Institute was the lead clinical investigator.
An estimated 785,000 new cases of heart attack in the United States each year, with no treatment established to repair damage to heart tissue. After a heart attack, scar tissue develops, decreasing muscle function and leading to heart failure. It is here that VentriGel intervenes. Once injected into a damaged heart muscle, VentriGel forms a scaffold that acts as a restorative environment in which healthy cells migrate, resulting in increased heart muscle, decreased scar tissue and improved cardiac function.
VentriGel was invented by Christman and his team, then licensed by UC San Diego and developed by Ventrix, Inc., co-founded by CEOs Adam Kinsey and Christman.
VentriGel is made from cardiac connective tissue derived from pigs, rid of its cardiac muscle cells during a cleansing process. It is then lyophilized and milled as a powder, and then liquefied in a fluid that can be easily injected into the heart muscle during a minimally invasive procedure that does not require surgery. Once the body temperature is reached, the liquid turns into a semi-solid and porous gel.
The Phase 1 trial evaluated the gel in 15 patients who experienced moderate lesions of the left ventricular cavity of the heart as a result of a heart attack. Each patient received up to 18 injections of VentriGel in the damaged area via a catheter. The researchers followed patients for six months after treatment. All patients completed the full follow-up.
Twelve of the 15 patients were men. All 15 had mild to moderate heart failure as a result of a heart attack. Half had a heart attack in the past year.
Patients underwent a six-minute walk test as well as an evaluation of cardiac function and a cardiac health questionnaire prior to injections. They retested the tests three and six months later. In addition, patients underwent MRI three and six months after the procedures.
Ventrix is now preparing for a Phase 2 clinical trial that will develop this first successful study on humans. They predict a larger randomized trial that will evaluate how effectively VentriGel can improve heart function and quality of life for patients with heart failure.
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Material provided by University of California – San Diego. Original written by Ioana Patringenaru. Note: Content can be changed for style and length.