Cell Therapy in Chagas Cardiomyopathy (Chagas Arm of the Multicenter Randomized Trial of Cell Therapy in Cardiopathies Study)

Abstract

Background-Previous studies suggested that transplantation of autologous bone marrow-derived mononuclear cells (BMNCs) improves heart function in chronic chagasic cardiomyopathy. We report the results of the first randomized trial of BMNC therapy in chronic chagasic cardiomyopathy. Methods and Results-Patients 18 to 75 years of age with chronic chagasic cardiomyopathy, New York HeartAssociation class II to IV heart failure, left ventricular ejection fraction (LVEF) Ͻ35%, and optimized therapy were randomized to intracoronary injection of autologous BMNCs or placebo. The primary end point was the difference in LVEF from baseline to 6 and 12 months after treatment between groups. Analysis was by intention to treat and powered to detect an absolute between-group difference of 5%.

2 nd Brazilian Consensus on Chagas Disease, 2015

“…The results did not show any benefit, even on surrogate outcomes such as the left ventricular ejection fraction (261) .…”

Developments in the management of Chagas cardiomyopathy

“…The success achieved with BMMC and MSC therapy in rodent model of Chagas cardiomyopathy led to clinical trials evaluating safety and efficacy of BMMC cell therapy in these patients. [144,146,147] Both trials involved patients with heart failure due to chronic Chagas cardiomyopathy, with severely compromised left ventricular ejection fraction (LVEF) and NYHA class III or IV. Bone marrow was aspirated and BMMCs enriched through gradient centrifugation were injected in coronary arteries.…”

The treatment of chronic heart failure secondary to Chagas cardiomyopathy in the contemporary era

“…8 Cell therapy is not of benefit for patients with Chagas cardiomyopathy with CHF. 61 Such patients, therefore, could be potentially considered for heart transplantation. Exceptionally, mechanical circulatory support can be offered to patients with this condition.…”