DCM Support: cell therapy and circulatory support for dilated cardiomyopathy patients with severe ventricular impairment.

Abstract

The DCM Support trial (NCT03572660) uses a percutaneous circulatory support device (Impella CP, Abiomed, Danvers, MA, USA) to improve the safety of an intracoronary cell infusion procedure in patients with dilated cardiomyopathy (DCM) and a severely reduced left ventricular ejection fraction (LVEF). DCM Support is a single-site, single-arm Phase II trial enrolling 20 symptomatic DCM patients with an LVEF≤35% despite optimal medical and device therapy. After 5days of granulocyte colony-stimulating factor therapy and a subsequent bone marrow aspiration, patients undergo an intracoronary infusion of autologous bone-marrow-derived mononuclear cells. The Impella CP device is used to provide haemodynamic support during the infusion procedure. The trial's primary endpoint is change in LVEF from baseline at 3months. Secondary efficacy endpoints are change in LVEF from baseline at 12months, and change in exercise capacity, New York Heart Association class, quality of life, and N-terminal pro-B-type natriuretic peptide levels from baseline at 3 and 12months. Safety endpoints include procedural safety and major adverse cardiac events at 3 and 12months. This is the first trial to assess the safety and efficacy of cytokine and autologous intracoronary cell therapy with a procedural circulatory support device for patients with severe left ventricular impairment. This novel combination may allow us to target a patient population most at need of this therapy.