VentriGel for the heart
Hydrogel for the treatment of heart attacks has successfully passed the first phase of clinical trials
Ekaterina Rusakova, N+1
Doctors have successfully conducted the first phase of clinical studies of VentriGel biomaterial, which improves heart function after myocardial infarction, according to the Journal of the American College of Cardiology: Basic to Translational Science. 15 patients who have had a heart attack over the past three years have successfully undergone injections of the drug. In addition, their well-being improved and they began to tolerate physical exertion better.
In recent decades, doctors have been developing methods of treating myocardial infarction and coronary heart disease using regenerative medicine. Basically, scientists are testing the action of various types of stem cells. Preparations based on the extracellular matrix – a three-dimensional structure consisting of macromolecules, in particular, proteins and glycoproteins, which is necessary for the normal functioning of cells, are also being investigated. However, so far the extracellular matrix is used mainly in reconstructive surgery to restore tissues after injury or illness. There are no drugs for the treatment of cardiovascular diseases containing extracellular matrix on the market yet.
It is worth noting that myocardial infarction leads not only to cell death. After it, inflammation develops, which leads to the destruction of the extracellular matrix, and a scar forms in the damaged tissue. In order to restore the natural extracellular matrix after myocardial infarction, researchers from Ventrix, a subsidiary of the University of California at San Diego, have created VentriGel hydrogel based on the extracellular matrix of the myocardium of pigs purified from cells. In vitro studies of the biomaterial have shown that it promoted the growth of endothelial cells forming blood vessels and the differentiation of stem cells in rat myocardial tissue. In animals that had suffered a myocardial infarction, the hydrogel helped to reduce the growth of connective tissue and improve heart function.
In 2014, the U.S. Food and Drug Administration approved the first phase of VentriGel clinical trials to ensure that the drug is safe for humans. For the tests, the creators of the drug selected 15 people 45-69 years old, 12 of them men. All of them had suffered a myocardial infarction from two months to three years before the start of the studies and they had moderate left ventricular dysfunction. The doctors administered up to 18 injections of VentriGel to the participants of the experiment and then monitored them for a year. Before the injection, as well as three and six months after them, the subjects underwent an MRI of the heart to assess the condition of the heart tissue, and checked how far they would travel during the test time. The participants also filled out a questionnaire assessing the quality of life, and doctors examined them and assigned them the level of heart failure according to the gradation of the New York Cardiological Association.
All patients underwent injections of the drug, and none of them interrupted the experimental treatment. The physical condition of the subjects improved, they began to carry loads better and walked a longer distance in the same time, on average 35.6 meters further (p=0.03) after three months, and 44.4 meters further (p=0.007) after six months. Also, according to the questionnaire, the patients' quality of life improved after a month (p=0.045). It continued to rise after three months and six months, but only slightly. In addition, the subjects' symptoms of heart failure decreased (p=0.04), which allowed doctors to assign the volunteers a higher level according to the New York Cardiology Association gradation - that is, the patients got better.
Ventrix is currently preparing to conduct the second phase of clinical trials, which will take place on a randomized sample with a large number of participants. The goal of the second phase is to find out how effectively hydrogel improves heart function in people with heart failure.
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