Open-label phase 1 study to evaluate off-the-shelf, biomaterial scaffold

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Ventrix has initiated a phase 1, open-label study of its off-the-shelf, biomaterial scaffold (VentriGel). The scaffold is designed to facilitate the repair of cardiac tissue following myocardial infarction. The open-label trial will enrol patients who have experienced a first myocardial infarction within the past three years and have evidence of left ventricular dysfunction.

A press release reports that the phase 1 clinical trial will enrol patients at three centres in the USA. It adds that the study will evaluate the safety and feasibility of the off-the-shelf, biomaterial scaffold for treating damaged cardiac tissue in patients who have had a myocardial infarction. Secondary endpoints of the study include efficacy variables for halting the progression of heart failure, including the heart’s stroke volume, ejection fraction and scar mass. According to the press release, VentriGel is a biomaterial scaffold designed specifically for the repair of damaged myocardium. It is injected via catheter in a minimally-invasive procedure that does not require surgery or general anaesthesia.

Paul Chamberlin, chief medical officer of Ventrix, says: “We have demonstrated statistically significant efficacy for VentriGel in our preclinical studies and are hopeful to see the benefits translated to patients.For people who have survived heart attacks, congestive heart failure is a common, costly and potentially fatal condition, and treatment options are severely limited. With our approach, we hope to alter the negative remodelling post-myocardial infarction that leads to heart failure.”