Results of Intracoronary Stem Cell Therapy After Acute Myocardial Infarction
| Autor: | Volker Mailänder, Fabian von Scheidt, Nico Merkle, Martin Bommer, Markus Wiesneth, Thorsten Nusser, Jochen Wöhrle, Vinzenz Hombach, Peter Schauwecker, Klaus Schwarz, Hubert Schrezenmeier |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Myocardial Infarction Placebo Ventricular Function Left law.invention Double-Blind Method Randomized controlled trial law Cardiac magnetic resonance imaging Internal medicine Clinical endpoint medicine Humans Myocardial infarction Aged Bone Marrow Transplantation Ejection fraction medicine.diagnostic_test business.industry Stroke Volume Magnetic resonance imaging Stroke volume Middle Aged medicine.disease Magnetic Resonance Imaging Cardiology Female Cardiology and Cardiovascular Medicine business Stem Cell Transplantation |
| Zdroj: | The American Journal of Cardiology. 105:804-812 |
| ISSN: | 0002-9149 |
| DOI: | 10.1016/j.amjcard.2009.10.060 |
| Popis: | To assess the effect of autologous bone-marrow cell (BMC) therapy in patients with acute myocardial infarction in a rigorous double-blind, randomized, placebo-controlled trial. Patients with reperfusion6 hours after symptom onset were randomly assigned in a 2:1 ratio to receive intracoronary BMC or placebo therapy 5 to 7 days after symptom onset. The patients were stratified according to age, acute myocardial infarction localization, and left ventricular (LV) function. Rigorous double-blinding was ensured using autologous erythrocytes for the placebo preparation that was visually indistinguishable from the active treatment. Serial cardiac magnetic resonance imaging studies were performed before study therapy and after 1, 3, and 6 months. The primary end point was the difference in the LV ejection fraction from baseline to 6 months. The secondary end points included changes in the LV end-diastolic and end-systolic volume indexes and infarct size. A total of 42 patients were enrolled (29 in the BMC group and 13 in the placebo group) in the integrated pilot phase. A mean of 381 x 10(6) mononuclear BMCs were administered. The baseline clinical and cardiac magnetic resonance imaging parameters did not differ. Compared to baseline, the difference in LV ejection fraction for the placebo group versus BMC group was 1.7 +/- 6.4% versus -0.9 +/- 5.5% at 1 month, 3.1 +/- 6.0% versus 1.9 +/- 4.3% at 3 months, and 5.7 +/- 8.4% versus 1.8 +/- 5.3% at 6 months (primary end point; not significant). No difference was found in the secondary end points between the 2 groups, including changes in infarct size or LV end-diastolic and end-systolic volume indexes. In conclusion, in this rigorous double-blind, randomized, placebo-controlled trial, we did not observe an evidence for a positive effect for intracoronary BMC versus placebo therapy with respect to LV ejection fraction, LV volume indexes, or infarct size. |
| Databáze: | OpenAIRE |
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