Objectiv: To assess the safety and efficacy of autologous bone marrow – derived mononuclear stem cell therapy in patients with severe chronic ischemic heart failure on short to medium-term (1-3 months).
Methods: The SAFE-HF study is a prospective, single center, two-arm, controlled trial with blind evaluation of endpoints. Twenty patients within 1 to 3 months af-ter a STEMI and residual left LVEF <35% will be enrol-led. Evolution of stem cell treated patients (n=10) will be compared with matched control–cases (n=10). Nei-ther bone marrow aspiration nor sham injection will be performed in the control group. Follow-up visits will be conducted at 1 month and respectively 3 months sin-ce inclusion time. In-depth outcome evaluation will be performed in terms of serum biomarkers (NT-proBNP, circulating endothelial progenitor cells and micropar-ticles of endothelial and platelet origin), cardiac struc-tural and physiological parameters, functional capacity and health-related quality of life.
Results: Results will be available starting with Decem-ber 2018 at http://www.urgentafloreasca.ro/fisiere/fon-duri_europene%20CARDIO.pdf.
Conclusions: Here in, we presented the methodology of a study designed to explore the safety and efficacy of stem cell therapy in patients with severe chronic ische-mic heart failure. Information gained will contribute to develop future trials to address this medical conditi-on. Acknowledgements: This work was supported by a grant of the Romanian National Authority for Scientific Research and Innovation, CNCS/CCCDI UEFISCDI, project number PN-III-P2-2.1-PED-2016-1333, within PNCDI III.