title: Implantation of CD133+ stem cells in patients undergoing coronary bypass surgery: IMPACT-CABG pilot trial.
abstract: BACKGROUND
  The Implantation of Autologous CD133(+) Stem Cells in Patients Undergoing CABG (IMPACT-CABG) trial is investigating the feasibility, safety, and efficacy of intramyocardial injections of autologous CD133(+) stem cells during coronary artery bypass grafting (CABG) in patients with chronic ischemic cardiomyopathy. We are reporting the results of the first 5 open-label patients.
  
  
  METHODS
  Bone marrow was harvested from iliac crests and stem cells were isolated using the CliniMACS CD133(+) Reagent System (Miltenyi Biotec, GmbH, Bergisch Gladbach, Germany). Patients received CABG, followed by CD133(+) cellular injection in the revascularized hypokinetic myocardium.
  
  
  RESULTS
  Five males New York Heart Association (NYHA) class III patients aged 64 ± 10 years were treated. Immunomagnetic cell processing allowed an average of 100 ± 48-fold enrichment in CD133(+) cells, with 92 ± 11% recovery after selection. Mean number of CD133(+) cells injected was 8.4 ± 1.2 million. There were no protocol-related complications during the 18-month follow-up and all patients improved to NYHA class I. Six-month echocardiography showed no significant improvement in left ventricular ejection fraction (34 ± 2% at baseline vs 38 ± 12%: P = 0.50). However, cardiac magnetic resonance showed that systolic wall thickening increased from 15.0 ± 10.5% to 29.0 ± 22.1% (P = 0.01). In addition, mean segmental wall thickness also improved in comparison with baseline (10.7 ± 2.7% to 12.1 ± 4.8%; P < 0.01).
  
  
  CONCLUSIONS
  This work represents the first Canadian experience with CD133(+) stem cells for the treatment of chronic ischemic cardiomyopathy. These results demonstrate the initial safety and feasibility of the IMPACT-CABG pilot trial. Subsequent patients are now being randomized to receive either CD133(+) stem cell or placebo.
authors.affiliation: Division of Cardiac Surgery, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
authors.forename: Jessica
authors.initials: J
authors.lastname: Forcillo
authors.forename: Louis-Mathieu
authors.initials: LM
authors.lastname: Stevens
authors.forename: Samer
authors.initials: S
authors.lastname: Mansour
authors.forename: Ignacio
authors.initials: I
authors.lastname: Prieto
authors.forename: Reda
authors.initials: R
authors.lastname: Salem
authors.forename: Chantal
authors.initials: C
authors.lastname: Baron
authors.forename: Denis-Claude
authors.initials: DC
authors.lastname: Roy
authors.forename: Eric
authors.initials: E
authors.lastname: Larose
authors.forename: Daiana
authors.initials: D
authors.lastname: Masckauchan
authors.forename: Nicolas
authors.initials: N
authors.lastname: Noiseux
mesh_terms: D000071916:AC133 Antigen; D000368:Aged; D015703:Antigens, CD / Q000009:adverse effects; D002170:Canada; D002908:Chronic Disease; D001026:Coronary Artery Bypass / Q000379:methods; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006023:Glycoproteins / Q000009:adverse effects; D006801:Humans; D007267:Injections; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D009206:Myocardium / Q000473:pathology*; D010455:Peptides / Q000009:adverse effects; D010865:Pilot Projects; D012720:Severity of Illness Index; D013318:Stroke Volume; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D000071916:AC133 Antigen; D015703:Antigens, CD; D006023:Glycoproteins; C000606023:PROM1 protein, human; D010455:Peptides