Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study.

Intramyocardial transplantation of autologous bone marrow mononuclear cells (BMMC) is believed to be a promising method for the treatment of patients with chronic ischemic heart disease. The aim of this study was to evaluate long-term results of intramyocardial bone marrow cell transplantation in patients with severe ischemic heart failure. One hundred nine patients with chronic myocardial infarction and end-stage chronic heart failure were randomized into two groups: 55 patients received intramyocardial BMMC injection and 54 received optimal medical therapy. The NOGA system (Biosense-Webster) was used to administer 41 +/- 16 x 106 BMMC into the border zone of myocardial infarction. None of the patients developed periprocedural complications following BMMC injections. The injections led to improvement of CCS class (3.1 +/- 0.4 to 1.6 +/- 0.6 after 6 months and 1.6 +/- 0.4 after 12 months; p = 0.001) and NYHA functional class (3.3 +/- 0.2 to 2.3 +/- 0.2 after 6 months and 2.5 +/- 0.1 after 12 months; p = 0.006). Left ventricular ejection fraction increased significantly in the BMMC group (27.8 +/- 3.4% vs 32.3 +/- 4.1%; p = 0.04) while it tended to decrease in the control group (26.8 +/- 3.8% to 25.2 +/- 4.1%; p = 0.61). Summed rest score improved in the BMMC group after 12 months (30.2 +/- 5.6 to 27.8 +/- 5.1; p = 0.032). The improvement of stress score was more noticeable (34.5 +/- 5.4 to 28.1 +/- 5.2; p = 0.016). Neither stress nor rest score changed in patients numbers on medical therapy. In BMMC group 6 (10.9%) patients died at 12-month follow-up compared with 21 (38.9%) in control group (log-rank test, p = 0.0007). Intramyocardial bone marrow cell transplantation to patients with ischemic heart failure is safe and improved survival, clinical symptoms, and has beneficial effect on LV function.

RCT Entities:   Population Interventions Outcomes