title: Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction (TOPCARE-AMI): final 5-year results suggest long-term safety and efficacy.
abstract: BACKGROUND
  Limited data is available for investigating the long-term safety and effects of intracoronary progenitor cell therapy in patients with acute myocardial infarction (AMI).
  
  
  OBJECTIVE
  To assess the clinical course, NT-proBNP and MRI data as objective markers of cardiac function of the TOPCARE-AMI patients at 5-year follow-up.
  
  
  METHODS
  The TOPCARE-AMI trial was the first randomized study investigating the effects of intracoronary infusion of circulating (CPC) or bone marrow-derived progenitor cells (BMC) in 59 patients with successfully reperfused AMI.
  
  
  RESULTS
  Five-year follow-up data were completed in 55 patients, 3 patients were lost to follow-up. None of the patients showed any signs of intramyocardial calcification or tumors at 5 years. One patient died during the initial hospitalization, no patient was rehospitalized for heart failure and 16 patients underwent target vessel revascularization (TVR). Only two TVRs occurred later than 1 year after cell administration making it very unlikely that the infused cells accelerate atherosclerotic disease progression. Serum levels of NT-proBNP remained significantly reduced at the 5-year follow-up indicating the absence of heart failure. MRI subgroup analysis in 31 patients documented a persistent improvement of LV ejection fraction (from 46 ± 10% at baseline to 57 ± 10% at 5 years, p < 0.001)). Simultaneously, there was a reduction (p < 0.001) in functional infarct size measured as late enhancement volume normalized to LV mass. However, whereas LV end-systolic volume remained stable, LV end-diastolic volume increased significantly.
  
  
  CONCLUSIONS
  The 5-year follow-up of the TOPCARE-AMI trial provides reassurance with respect to the long-term safety of intracoronary cell therapy and suggests favorable effects on LV function.
authors.affiliation: Division of Cardiology, Department of Medicine III, Goethe University Frankfurt, Germany.
authors.forename: David M
authors.initials: DM
authors.lastname: Leistner
authors.forename: Ulrich
authors.initials: U
authors.lastname: Fischer-Rasokat
authors.forename: Jörg
authors.initials: J
authors.lastname: Honold
authors.forename: Florian H
authors.initials: FH
authors.lastname: Seeger
authors.forename: Volker
authors.initials: V
authors.lastname: Schächinger
authors.forename: Ralf
authors.initials: R
authors.lastname: Lehmann
authors.forename: Hans
authors.initials: H
authors.lastname: Martin
authors.forename: Iris
authors.initials: I
authors.lastname: Burck
authors.forename: Carmen
authors.initials: C
authors.lastname: Urbich
authors.forename: Stefanie
authors.initials: S
authors.lastname: Dimmeler
authors.forename: Andreas M
authors.initials: AM
authors.lastname: Zeiher
authors.forename: Birgit
authors.initials: B
authors.lastname: Assmus
mesh_terms: D000328:Adult; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D015415:Biomarkers / Q000097:blood; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000401:mortality / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D009206:Myocardium / Q000473:pathology*; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D020127:Recovery of Function; D012038:Regeneration; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000401:mortality; D015607:Stents; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
chemical_list: D015415:Biomarkers; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain