PMID- 15489105 OWN - NLM STAT- MEDLINE DCOM- 20041130 LR - 20071115 IS - 0735-1097 (Print) IS - 0735-1097 (Linking) VI - 44 IP - 8 DP - 2004 Oct 19 TI - Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final one-year results of the TOPCARE-AMI Trial. PG - 1690-9 AB - OBJECTIVES: The Transplantation of Progenitor Cells And Regeneration Enhancement in Acute Myocardial Infarction (TOPCARE-AMI) trial investigates both safety, feasibility, and potential effects on parameters of myocardial function of intracoronary infusion of either circulating progenitor cells (CPC) or bone marrow-derived progenitor cells (BMC) in patients with acute myocardial infarction (AMI). BACKGROUND: In animal experiments, therapy with adult progenitor cells was shown to improve vascularization, left ventricular (LV) remodeling, and contractility after AMI. METHODS: A total of 59 patients with AMI were randomly assigned to receive either CPC (n = 30) or BMC (n = 29) into the infarct artery at 4.9 +/- 1.5 days after AMI. RESULTS: Intracoronary progenitor cell application did not incur any measurable ischemic myocardial damage, but one patient experienced distal embolization before cell therapy. During hospital follow-up, one patient in each cell group developed myocardial infarction; one of these patients died of cardiogenic shock. No further cardiovascular events, including ventricular arrhythmias or syncope, occurred during one-year follow-up. By quantitative LV angiography at four months, LV ejection fraction (EF) significantly increased (50 +/- 10% to 58 +/- 10%; p < 0.001), and end-systolic volumes significantly decreased (54 +/- 19 ml to 44 +/- 20 ml; p < 0.001), without differences between the two cell groups. Contrast-enhanced magnetic resonance imaging after one year revealed an increased EF (p < 0.001), reduced infarct size (p < 0.001), and absence of reactive hypertrophy, suggesting functional regeneration of the infarcted ventricles. CONCLUSIONS: Intracoronary infusion of progenitor cells (either BMC or CPC) is safe and feasible in patients after AMI successfully revascularized by stent implantation. Both the excellent safety profile and the observed favorable effects on LV remodeling, provide the rationale for larger randomized double-blind trials. FAU - Schachinger, Volker AU - Schachinger V AD - Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany. FAU - Assmus, Birgit AU - Assmus B FAU - Britten, Martina B AU - Britten MB FAU - Honold, Jorg AU - Honold J FAU - Lehmann, Ralf AU - Lehmann R FAU - Teupe, Claudius AU - Teupe C FAU - Abolmaali, Nasreddin D AU - Abolmaali ND FAU - Vogl, Thomas J AU - Vogl TJ FAU - Hofmann, Wolf-Karsten AU - Hofmann WK FAU - Martin, Hans AU - Martin H FAU - Dimmeler, Stefanie AU - Dimmeler S FAU - Zeiher, Andreas M AU - Zeiher AM LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 SB - IM MH - Adolescent MH - Adult MH - Aged MH - *Bone Marrow Transplantation MH - Coronary Circulation/physiology MH - Feasibility Studies MH - Female MH - Follow-Up Studies MH - Heart Ventricles/physiopathology MH - *Hematopoietic Stem Cell Transplantation MH - Hemodynamics/physiology MH - Humans MH - Magnetic Resonance Imaging MH - Male MH - Middle Aged MH - Myocardial Contraction/physiology MH - Myocardial Infarction/mortality/physiopathology/*surgery MH - Pilot Projects MH - Postoperative Complications/mortality MH - Regeneration/physiology MH - Shock, Cardiogenic/mortality MH - Ventricular Remodeling/physiology EDAT- 2004/10/19 09:00 MHDA- 2004/12/16 09:00 CRDT- 2004/10/19 09:00 PHST- 2004/06/08 00:00 [received] PHST- 2004/06/24 00:00 [revised] PHST- 2004/08/02 00:00 [accepted] PHST- 2004/10/19 09:00 [pubmed] PHST- 2004/12/16 09:00 [medline] PHST- 2004/10/19 09:00 [entrez] AID - S0735-1097(04)01629-8 [pii] AID - 10.1016/j.jacc.2004.08.014 [doi] PST - ppublish SO - J Am Coll Cardiol. 2004 Oct 19;44(8):1690-9. doi: 10.1016/j.jacc.2004.08.014.