Objectives To invest the effects and safety of autologous bone marrow–derived mononuclear cells (BMMNCs) transplantation in dilated cardiomyopathy. We report the results of the randomised trial of BMMNCs therapy in 20 patients with dilated cardiomyopathy
Methods Patients 18 to 67 years of age with dilated cardiomyopathy, New York Heart Association class III to IV heart failure, left ventricular ejection fraction (LVEF) <35%, were randomised to intracoronary injection of autologous BMMNCs or ordinary drugs treatment. The primary end point was the difference in the effectiveness and safety from baseline to 6 months after treatment between groups.
Results Between June 2008 and June 2012, 20 patients were enrolled. Among the 20 patients, 12 patients in the control group and 8 patients in the BMMNCs group. Median number of injected BMMNCs was 2.90 × 109 (range, 1.80∼5.90 × 109). Change in LVEF differ significantly between the two groups at 6 months, mean change in LVEF, 45.4 ± 5.2% for BMMNCs group and 39.2% ± 6.3% for control group (P < 0.05); change in LVEDd, 50.3 ± 4.2 for BMMNCs group and 55.4 ± 3.7 for placebo group (P < 0.05). and 6-minute walking test also differ between the two groups (P < 0.05).
Conclusions Intracoronary injection of autologous BMMNCs improve left ventricular function or quality of life in patients with cardiomyopathy. The Intracoronary injection of autologous BMMNCs was effects and safety at 6 months after treatment. But the longer effects and safety of the Intracoronary injection of autologous BMMNCs is under investigation.