Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction: the MYSTAR prospective, randomized study.
Mariann Gyöngyösi, Irene Lang, Markus Dettke, Gilbert Beran, Senta Graf, Heinz Sochor, Noémi Nyolczas, Silvia Charwat, Rayyan Hemetsberger, Günter Christ, István Edes, László Balogh, Korff Thomas Krause, Kai Jaquet, Karl-Heinz Kuck, Imre Benedek, Theodora Hintea, Róbert Kiss, István Préda, Vladimir Kotevski, Hristo Pejkov, Sholeh Zamini, Aliasghar Khorsand, Gottfried Sodeck, Alexandra Kaider, Gerald Maurer, Dietmar Glogar
Author Information
Mariann Gyöngyösi: Department of Cardiology, Medical University of Vienna, Austria. mariann.gyongyosi@meduniwien.ac.at
BACKGROUND: Combined intracoronary and intramyocardial administration might improve outcomes for bone-marrow-derived stem cell therapy for acute myocardial infarction (AMI). We compared the safety and feasibility of early and late delivery of stem cells with combined therapy approaches. METHODS: patients with left ventricular ejection fraction less than 45% after AMI were randomly assigned stem cell delivery via intramyocardial injection and intracoronary infusion 3-6 weeks or 3-4 months after AMI. Primary end points were changes in infarct size and left ventricular ejection fraction 3 months after therapy. RESULTS: A total of 60 patients were treated. The mean changes in infarct size at 3 months were -3.5 +/- 5.1% (95% CI -5.5% to -1.5%, P = 0.001) in the early group and -3.9 +/- 5.6% (95% CI -6.1% to -1.6%, P = 0.002) in the late group, and changes in ejection fraction were 3.5 +/- 5.6% (95% CI 1.3-5.6%, P = 0.003) and 3.4 +/- 7.0% (95% CI 0.7-6.1%, P = 0.017), respectively. At 9-12 months after AMI, ejection fraction remained significantly higher than at baseline in both groups. In the early and late groups, a mean of 200.3 +/- 68.7 x 10(6) and 194.8 +/- 60.4 x 10(6) stem cells, respectively, were delivered to the myocardium, and 1.30 +/- 0.68 x 10(9) and 1.29 +/- 0.41 x 10(9) cells, respectively, were delivered into the artery. A high number of cells was required for significant improvements in the primary end points. CONCLUSIONS: Combined cardiac stem cell delivery induces a moderate but significant improvement in myocardial infarct size and left ventricular function.
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