Research in Cardiovascular Medicine (Jan 2018)
The Effect of Intracoronary Infusion of Bone Marrow-derived Mononuclear Cells on Clinical Outcome and Cardiac Function in Chronic Heart Failure Patients: An Uncontrolled Study
Abstract
Objective: To evaluate the effect of bone marrow-derived mononuclear cells (BM-MNCs) on clinical outcome and cardiac function in chronic heart failure (HF). Methods: An uncontrolled, open-label trial was performed on symptomatic patients (New York Heart Association [NYHA] Functional Classification II–IV) receiving maximal medical therapy for at least 2 months, with a left ventricular (LV) ejection fraction <25%. Patients were divided into ischemic and nonischemic subgroups. All patients underwent BM aspiration, isolation of BM-MNCs using a standardized system, and intracoronary infusion of BM-MNCs. Primary endpoints assessed in 36 months were changes in (1) LV systolic function and LV end-diastolic diameter by echocardiography and (2) clinical improvement. Secondary measures included other echocardiography measures and major adverse cardiac events and HF hospitalization. Phenotypic and functional analyses of the cell product were performed by the Royan Institute for stem Cell Biology and Technology laboratory. Results: We enrolled 58 patients in our study. There was a significant improvement to exercise and functional capacity (evaluated by NYHA classification and 6-min walking distance) with both groups (for all P < 0.001). A significant decline in serum N-terminal Prohormone of Brain Natriuretic Peptide(NT- ProBNP) was observed in ischemic group (P = 0.01), but it was not statistically significant in nonischemic group. No significant changes were found in LV systolic and diastolic function, right ventricular size and function, severity of Mitral and Tricuspid regurgitation and pulmonary arterial pressure. There was minimal decrease in LV end-diastolic diameter which was statistically significant in ischemic and nonischemic group (P = 0.008 and P = 0.01 accordingly). Our study revealed a remarkably safe profile for BM-MNC infusion. Conclusion: It seems that intracoronary infusion of bone marrow-derived mononuclear stem cells is a safe treatment for patients with advanced HF and further studies need to address the best type of cell, route of administration, and criteria for patient selection.
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