TRANSTEM pilot study - design, safety and results 6 months after autologous bone marrow stem cell transplant in patients with acute myocardial infarction and impaired left ventricular function

Background: Despite advancement in medical and interventional treatments, cardiac remodeling may occur in almost 60% of patients who suffered a myocardial infarction. Stem cell therapy is specifically addressed to myocardial hypoperfusion and loss of myocardial mass, with the major goal in prevention and improvement of cardiac remodeling. Objectives: We aimed to investigate the feasibility, safety and effectiveness of autologous bone marrow stem cell therapy in patients with acute myocardial infarction having moderate to severe systolic dysfunction 6 months after transplantation. Methods: Eighteen patients with a first acute myocardial infarction with ST-segment elevation (STEMI) were included in the study; they were assigned either to intracoronary infusion of bone marrow cell suspension or to the control group. Results: At 6 months follow-up, there were no significant differences between groups regarding major adverse cardiac events. Furthermore, cell therapy led to smaller left ventricular volumes and significantly improved function. Conclusions: The autologous bone marrow stem cell therapy has proven to be a reliable method that can be used in clinical practice in well selected cases. The precise indications, the optimal timing for cell administration and the processing method are still to be determined, as well as the long term effects of cellular therapy.