First-in-human trial shows hydrogel to repair heart is safe to inject.
There are an 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. However, tissues also include a scaffolding framework, the extracellular matrix (ECM), not just cells, meaning the majority of these trials fail. Now, a study from researchers at University of California San Diego successfully conducts a first-in-human, FDA-approved Phase 1 clinical trial of an injectable ECM hydrogel which aims to repair damage and restore cardiac function in heart failure patients who previously suffered a heart attack. The team state 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 that 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. However, when used to treat a heart attack they have been shown not to lessen scar tissue development due numerous factors, including injection placement and cell/ECM mix. The current study shows that 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, VentriGel, made from cardiac connective tissue taken from pigs, 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 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 catheter, and were followed for six months after treatment.
Results show once injected in damaged cardiac muscle, VentriGel forms a scaffold which acts as a reparative scaffold where healthy cells migrate, leading 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 decreases in New York Heart Association class across the entire cohort of patients.
The team surmise 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.