Abstract
The aim of this study was to determine if bone marrow mononuclear cell (BMMC) transplantation is safe for moderate to severe idiopathic dilated cardiomyopathy (IDC). Clinical trials have shown that this procedure is safe and effective for ischemic patients, but little information is available regarding non-ischemic patients. Twenty-four patients with IDC, optimized therapy, age 46 ± 11.6 years, 17 males, NYHA classes II-IV, and left ventricular ejection fraction <35% were enrolled in the study. Clinical evaluation at baseline and 6 months after stem cell therapy to assess heart function included echocardiogram, magnetic resonance imaging, cardiopulmonary test, Minnesota Quality of Life Questionnaire, and NYHA classification. After cell transplantation 1 patient showed a transient increase in enzyme levels and 2 patients presented arrhythmias that were reversed within 72 h. Four patients died during follow-up, between 6 and 12 weeks after therapy. Clinical evaluation showed improvement in most patients as reflected by statistically significant decreases in Minnesota Quality of Life Questionnaire (63 ± 17.9 baseline vs 28.8 ± 16.75 at 6 months) and in class III-IV NYHA patients (18/24 baseline vs 2/20 at 6 months). Cardiopulmonary exercise tests demonstrated increased peak oxygen consumption (12.2 ± 2.4 at baseline vs 15.8 ± 7.1 mL·kg⁻¹·min⁻¹ at 6 months) and walked distance (377.2 ± 85.4 vs 444.1 ± 77.9 m at 6 months) in the 6-min walk test, which was not accompanied by increased left ventricular ejection fraction. Our findings indicate that BMMC therapy in IDC patients with severe ventricular dysfunction is feasible and that larger, randomized and placebo-controlled trials are warranted.
Highlights
Dilated cardiomyopathy is the most common form of nonischemic cardiomyopathy, characterized by ventricular dilatation, cardiomyocyte death, thinning of chamber walls, and fibrosis [1,2,3]
Safety evaluation During the cell injection procedure one patient developed a transient right bundle branch blockage (RBBB), one patient had atrial fibrillation (AF) that was reversed with amiodarone within 8 h, and one patient showed an elevation in troponin I enzyme levels from 0.5 to 3.3 12 h after cell injection, without pain, ECG or hemodynamic instability that normalized within 72 h
No adverse events have been reported in a trial where mononuclear cells were delivered to the coronary arteries in 24 patients after coronary sinus occlusion [19]
Summary
Dilated cardiomyopathy is the most common form of nonischemic cardiomyopathy, characterized by ventricular dilatation, cardiomyocyte death, thinning of chamber walls, and fibrosis [1,2,3]. Patients with dilated cardiomyopathy frequently progress to end-stage heart failure. For these patients, the only available therapy is heart transplantation, which is limited to a very small number of patients. Cardiovascular stem cell therapy has been used successfully in a variety of cardiac diseases, including dilated cardiomyopathy [4,5,6,7,8,9]. Cell therapies have been previously used in patients with ischemic heart disease, both in the acute and chronic stages. Results have demonstrated excellent safety with encouraging signs of clinical improvement (1012,14-17)
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