AIMS: To investigate the clinical outcome after intracoronary administration of autologous progenitor cells in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: Using a double-blind, placebo-controlled multicentre trial design, we randomized 204 patients with successfully reperfused AMI to receiveintracoronary infusion of bone-marrow-derived progenitor cells (BMCs) or placebo medium into the infarct artery 3-7 days after successful infarct reperfusion therapy. At 12 months, the pre-specified cumulative endpoint of death, myocardial infarction, or necessity for revascularization was significantly reduced in the BMC group compared with placebo (P=0.009). Likewise, the combined endpoint death, recurrence of myocardial infarction, and rehospitalization for heart failure was significantly (P=0.006) reduced in patients receiving intracoronary BMC administration. Intracoronary administration of BMC remained a significant predictor of a favourable clinical outcome by Cox regression analysis, adjusting for classical predictors of poor outcome after AMI. CONCLUSION: Intracoronary administration of BMCs is associated with a significant reduction of the occurrence of major adverse cardiovascular events after AMI. Large-scale studies are warranted to confirm the effects of BMC administration on mortality and morbidity in patients with AMIs.
RCT Entities:
AIMS: To investigate the clinical outcome after intracoronary administration of autologous progenitor cells in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: Using a double-blind, placebo-controlled multicentre trial design, we randomized 204 patients with successfully reperfused AMI to receive intracoronary infusion of bone-marrow-derived progenitor cells (BMCs) or placebo medium into the infarct artery 3-7 days after successful infarct reperfusion therapy. At 12 months, the pre-specified cumulative endpoint of death, myocardial infarction, or necessity for revascularization was significantly reduced in the BMC group compared with placebo (P=0.009). Likewise, the combined endpoint death, recurrence of myocardial infarction, and rehospitalization for heart failure was significantly (P=0.006) reduced in patients receiving intracoronary BMC administration. Intracoronary administration of BMC remained a significant predictor of a favourable clinical outcome by Cox regression analysis, adjusting for classical predictors of poor outcome after AMI. CONCLUSION: Intracoronary administration of BMCs is associated with a significant reduction of the occurrence of major adverse cardiovascular events after AMI. Large-scale studies are warranted to confirm the effects of BMC administration on mortality and morbidity in patients with AMIs.
Authors: Ramazan Gökmen Turan; Ilkay Bozdag-Turan; Jasmin Ortak; Ibrahim Akin; Stephan Kische; Henrik Schneider; Cem Hakan Turan; Tim Christopher Rehders; Mathias Rauchhaus; Tilo Kleinfeldt; Ester Adolph; Micheal Brehm; Sedat Yokus; Stephan Steiner; Kurtulus Sahin; Christoph A Nienaber; Hüseyin Ince Journal: Stem Cells Dev Date: 2010-12-29 Impact factor: 3.272
Authors: Robert D Simari; Carl J Pepine; Jay H Traverse; Timothy D Henry; Roberto Bolli; Daniel B Spoon; Ed Yeh; Joshua M Hare; Ivonne Hernandez Schulman; R David Anderson; Charles Lambert; Shelly L Sayre; Doris A Taylor; Ray F Ebert; Lemuel A Moyé Journal: Circ Res Date: 2014-05-09 Impact factor: 17.367