ESC heart failure · 2023
DCM Support: cell therapy and circulatory support for dilated cardiomyopathy patients with severe ventricular impairment.
СтатьяResearch Support, N.I.H., IntramuralНазвание и аннотация: Перевод пока не подготовлен
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Reid Alice, Hussain Mohsin, Veerapen Jessry, Ramaseshan Rohini, Hall Russell, Bowles Ruth, Jones Daniel A, Mathur Anthony
Аннотация
AIMS: 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).
METHODS AND RESULTS: 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 5 days 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 3 months. Secondary efficacy endpoints are change in LVEF from baseline at 12 months, 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 12 months. Safety endpoints include procedural safety and major adverse cardiac events at 3 and 12 months.
CONCLUSIONS: 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.
METHODS AND RESULTS: 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 5 days 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 3 months. Secondary efficacy endpoints are change in LVEF from baseline at 12 months, 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 12 months. Safety endpoints include procedural safety and major adverse cardiac events at 3 and 12 months.
CONCLUSIONS: 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.