A First-in-human trial shows hydrogel to repair heart is safe to inject.

There are a staggering estimated 785,000 new heart attack cases in the United States each year, with no gold standard treatment for repairing the resulting damage to cardiac tissue. There has been much interest in using regenerative medicine to treat heart attack sufferers, with the vast majority of trials involving stem cells. Yet the majority of these trials fail as these regenerative tissues also include a scaffolding framework called extracellular matrixes (ECM).

Injectable heart-repair system

Now, a study from researchers at the University of California San Diego successfully conducts a first-in-human, FDA-approved Phase 1 clinical trial of an injectable ECM hydrogel. The aim of their investigation is to repair damage and restore cardiac function in heart failure patients. The team states their trial is the first to test an ECM hydrogel made from the natural scaffolding of cardiac muscle tissue and designed to repair cardiac tissue. The opensource study is published in the Journal of the American College of Cardiology: Basic to Translational Science.

Previous studies show after a heart attack, scar tissue develops, which lessens muscle function and leads to heart failure. The natural ECM influences all aspects of cell behavior necessary for proper tissue function as well as repair. Synthetic ECM hydrogels have been shown in preclinical studies to be effective for other conditions, such as poor blood circulation due to peripheral artery disease.

Still, when used to treat a heart attack they have been shown not to lessen scar tissue development due to numerous factors, including injection placement and cell/ECM mix. The current study shows an ECM hydrogel, known as VentriGel, can be safely injected via into patients who have suffered a heart attack in the past 2 to 36 months.

The current study develops an ECM hydrogel, dubbed VentriGel, made from cardiac connective tissue taken from pigs. Firstly, the connective tissue is stripped of heart muscle cells through a cleansing process. Next, it is then freeze-dried and milled into powder form. Finally, it is liquefied into a fluid to enable it to be injected into the heart where it turns into a semi-solid, porous gel.

The Phase 1 trial evaluates the gel in 15 patients with moderate damage to the left ventricle of the heart sustained after a heart attack. Each patient received up to 18 injections of VentriGel into the damaged region via a catheter and followed for six months after treatment.

A gel matrix instead of a scaffold

Results show once injected in damaged cardiac muscle, VentriGel forms a reparative scaffold where healthy cells migrate. This, in turn, leads to increases in cardiac muscle, less scar tissue, and improvements in heart function. Data findings show increases in a 6-minute walk test distance and decrease in the New York Heart Association class across the entire cohort of patients.

The team surmises they have successfully completed the first-in-man study of a cardiac ECM hydrogel in early and late-stage heart attack patients. For the future, the researchers state they’re now gearing up for a Phase 2 clinical trial which will expand on this successful first-in-human study.

Source: University of California – San Diego

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