title: Intracoronary infusion of mononuclear cells from bone marrow or peripheral blood compared with standard therapy in patients after acute myocardial infarction treated by primary percutaneous coronary intervention: results of the randomized controlled HEBE trial.
abstract: OBJECTIVE
  Previous trials that investigated cell therapy as an adjunctive therapy after acute myocardial infarction (AMI) have shown conflicting results. We designed a randomized controlled trial to determine the effect of intracoronary infusion of mononuclear cells from bone marrow (BM) or peripheral blood in patients with AMI.
  
  
  RESULTS
  In a multicentre trial, 200 patients with large first AMI treated with primary percutaneous coronary intervention were randomly assigned to either intracoronary infusion of mononuclear BM cells (n = 69), mononuclear peripheral blood cells (n = 66), or standard therapy (without placebo infusion) (n = 65). Mononuclear cells were delivered intracoronary between 3 and 8 days after AMI. Regional and global left ventricular myocardial function and volumes were assessed by magnetic resonance imaging before randomization and at 4 months, and clinical events were reported. The primary endpoint of the percentage of dysfunctional left ventricular segments that improved during follow-up did not differ significantly between either of the treatment groups and control: 38.6 ± 24.7% in the BM group, 36.8 ± 20.9% in the peripheral blood group, and 42.4 ± 18.7% in the control group (P = 0.33 and P = 0.14). Improvement of left ventricular ejection fraction was 3.8 ± 7.4% in the BM group, 4.2 ± 6.2% in the peripheral blood group when compared with 4.0 ± 5.8% in the control group (P = 0.94 and P = 0.90). Furthermore, the three groups did not differ significantly in changes in left ventricular volumes, mass, and infarct size and had similar rates of clinical events.
  
  
  CONCLUSIONS
  Intracoronary infusion of mononuclear cells from BM or peripheral blood following AMI does not improve regional or global systolic myocardial function in the HEBE trial.
  
  
  BACKGROUND
  The Netherlands Trial Register #NTR166 (www.trialregister.nl) and the International Standard Randomised Controlled Trial, #ISRCTN95796863 (http://isrctn.org).
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, PO Box 22660, 1100 DD Amsterdam, The Netherlands.
authors.forename: Alexander
authors.initials: A
authors.lastname: Hirsch
authors.forename: Robin
authors.initials: R
authors.lastname: Nijveldt
authors.forename: Pieter A
authors.initials: PA
authors.lastname: van der Vleuten
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: René A
authors.initials: RA
authors.lastname: Tio
authors.forename: Johannes
authors.initials: J
authors.lastname: Waltenberger
authors.forename: Jurrien M
authors.initials: JM
authors.lastname: ten Berg
authors.forename: Pieter A
authors.initials: PA
authors.lastname: Doevendans
authors.forename: Wim R M
authors.initials: WR
authors.lastname: Aengevaeren
authors.forename: Jaap Jan
authors.initials: JJ
authors.lastname: Zwaginga
authors.forename: Bart J
authors.initials: BJ
authors.lastname: Biemond
authors.forename: Albert C
authors.initials: AC
authors.lastname: van Rossum
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Piek
authors.forename: Felix
authors.initials: F
authors.lastname: Zijlstra
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D016026:Bone Marrow Transplantation / Q000379:methods*; D003331:Coronary Vessels; D005260:Female; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000503:physiopathology / Q000628:therapy*; D015425:Myocardial Reperfusion / Q000379:methods; D013318:Stroke Volume / Q000502:physiology; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000628:therapy