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INTRACORONARY STEM CELL THERAPY AFTER MYOCARDIAL INFARCTION - TWELVE MONTHS FOLLOW-UP OF A RANDOMIZED, RIGOROUS DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL
A100.E938 JACC March 9, 2010 Volume 55, issue 10A
MYOCARDIAL ISCHEMIA AND INFARCTION INTRACORONARY STEM CELL THERAPY AFTER MYOCARDIAL INFARCTION - TWELVE MONTHS FOLLOWUP OF A RANDOMIZED, RIGOROUS DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL ACC Poster Contributions Georgia World Congress Center, Hall B5 Sunday, March 14, 2010, 9:30 a.m.-10:30 a.m.
Session Title: Acute Myocardial Infarction--Cell Based Therapy and Cellular Manipulations Abstract Category: Acute Myocardial Infarction--Therapy Presentation Number: 1043-262 Authors: Jochen Wöhrle, Nico Merkle, Volker Mailänder, Thorsten Nusser, Peter Schauwecker, Fabian von Scheidt, Klaus Schwarz, Martin Bommer, Markus Wiesneth, Hubert Schrezenmeier, Vinzenz Hombach, Clinic of Internal Medicine II, University of Ulm, Ulm, Germany, Institute of Transfusion Medicine and Institute of Clinical Transfusion Medicine and Immunogenetics, Ulm, Germany Background: To assess the impact of autologous bone-marrow cell (BMC) therapy in patients with acute myocardial infarction (AMI) on left ventricular (LV) ejection fraction determined by cardiac magnetic resonance imaging (CMRI) in a rigorous double-blind, randomized, placebocontrolled trial. Methods: Patients with reperfusion >6 hours after symptom onset were randomly assigned in a 2:1 ratio to receive intracoronary BMC or placebo therapy 5-7 days after symptom onset. Patients were stratified according to age, AMI localization and LV function. Rigorous double-blinding was assured using autologous erythrocytes for placebo preparation visually indistinguishable from verum. Ficoll preparation was used for BMC therapy. Serial CMRI studies were performed: prior study therapy and after 1,3, 6 and 12 months.Primary endpoint was difference in LV ejection fraction between baseline and 6 months. Secondary endpoints included changes of LV enddiastolic and endsystolic volume indices and infarct size. Results: 42 patients were enrolled (29 BMC, 13 placebo) in the integrated pilot phase. A mean of 381(227-629)x10E6 mononuclear BMCs were administered. Viability of cells was 99%. Surface markers were analyzed by FACS. Baseline clinical and CMRI parameters did not differ between placebo and verum treated patients with 55.7±9.4% vs 53.5±9.3% for LV ejection fraction, and 28.1±10.3 vs 27.2±12.3% for infarct size as percent of LV muscle mass. As compared to baseline difference in LV ejection fraction for placebo versus BMC treatment at 1 month was 1.7±6.4% vs -0.9±5.5%, at 3 months 3.1±6.0% vs 1.9±4.3% and at 6 months (primary endpoint) 5.7±8.4% vs 1.8±5.3% (all ns). There was no difference in secondary endpoints between groups including changes of infarct size, LV enddiastolic and endsystolic volume indices (all ns). Twelve months followup including an additional CMRI study will be completed. Conclusions: In this rigorous double-blind, randomized, placebo-controlled trial we did not observe an evidence for a positive effect for intracoronary BMC as compared to placebo therapy with respect to LV ejection fraction, LV volume indices and infarct size with serial cardiac magnetic resonance imaging.
MYOCARDIAL ISCHEMIA AND INFARCTION INTRACORONARY STEM CELL THERAPY AFTER MYOCARDIAL INFARCTION - TWELVE MONTHS FOLLOWUP OF A RANDOMIZED, RIGOROUS DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL ACC Poster Contributions Georgia World Congress Center, Hall B5 Sunday, March 14, 2010, 9:30 a.m.-10:30 a.m.
Session Title: Acute Myocardial Infarction--Cell Based Therapy and Cellular Manipulations Abstract Category: Acute Myocardial Infarction--Therapy Presentation Number: 1043-262 Authors: Jochen Wöhrle, Nico Merkle, Volker Mailänder, Thorsten Nusser, Peter Schauwecker, Fabian von Scheidt, Klaus Schwarz, Martin Bommer, Markus Wiesneth, Hubert Schrezenmeier, Vinzenz Hombach, Clinic of Internal Medicine II, University of Ulm, Ulm, Germany, Institute of Transfusion Medicine and Institute of Clinical Transfusion Medicine and Immunogenetics, Ulm, Germany Background: To assess the impact of autologous bone-marrow cell (BMC) therapy in patients with acute myocardial infarction (AMI) on left ventricular (LV) ejection fraction determined by cardiac magnetic resonance imaging (CMRI) in a rigorous double-blind, randomized, placebocontrolled trial. Methods: Patients with reperfusion >6 hours after symptom onset were randomly assigned in a 2:1 ratio to receive intracoronary BMC or placebo therapy 5-7 days after symptom onset. Patients were stratified according to age, AMI localization and LV function. Rigorous double-blinding was assured using autologous erythrocytes for placebo preparation visually indistinguishable from verum. Ficoll preparation was used for BMC therapy. Serial CMRI studies were performed: prior study therapy and after 1,3, 6 and 12 months.Primary endpoint was difference in LV ejection fraction between baseline and 6 months. Secondary endpoints included changes of LV enddiastolic and endsystolic volume indices and infarct size. Results: 42 patients were enrolled (29 BMC, 13 placebo) in the integrated pilot phase. A mean of 381(227-629)x10E6 mononuclear BMCs were administered. Viability of cells was 99%. Surface markers were analyzed by FACS. Baseline clinical and CMRI parameters did not differ between placebo and verum treated patients with 55.7±9.4% vs 53.5±9.3% for LV ejection fraction, and 28.1±10.3 vs 27.2±12.3% for infarct size as percent of LV muscle mass. As compared to baseline difference in LV ejection fraction for placebo versus BMC treatment at 1 month was 1.7±6.4% vs -0.9±5.5%, at 3 months 3.1±6.0% vs 1.9±4.3% and at 6 months (primary endpoint) 5.7±8.4% vs 1.8±5.3% (all ns). There was no difference in secondary endpoints between groups including changes of infarct size, LV enddiastolic and endsystolic volume indices (all ns). Twelve months followup including an additional CMRI study will be completed. Conclusions: In this rigorous double-blind, randomized, placebo-controlled trial we did not observe an evidence for a positive effect for intracoronary BMC as compared to placebo therapy with respect to LV ejection fraction, LV volume indices and infarct size with serial cardiac magnetic resonance imaging.