title: The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) trial: first randomized placebo-controlled study of myoblast transplantation.
abstract: BACKGROUND
  Phase I clinical studies have demonstrated the feasibility of implanting autologous skeletal myoblasts in postinfarction scars. However, they have failed to determine whether this procedure was functionally effective and arrhythmogenic.
  
  
  RESULTS
  This multicenter, randomized, placebo-controlled, double-blind study included patients with left ventricular (LV) dysfunction (ejection fraction < or = 35%), myocardial infarction, and indication for coronary surgery. Each patient received either cells grown from a skeletal muscle biopsy or a placebo solution injected in and around the scar. All patients received an implantable cardioverter-defibrillator. The primary efficacy end points were the 6-month changes in global and regional LV function assessed by echocardiography. The safety end points comprised a composite index of major cardiac adverse events and ventricular arrhythmias. Ninety-seven patients received myoblasts (400 or 800 million; n=33 and n=34, respectively) or the placebo (n=30). Myoblast transfer did not improve regional or global LV function beyond that seen in control patients. The absolute change in ejection fraction (median [interquartile range]) between 6 months and baseline was 4.4% (0.2; 7.3), 3.4% (-0.3; 12.4), and 5.2% (-4.4; 11.0) in the placebo, low-dose, and high-dose groups, respectively (P=0.95). However, the high-dose cell group demonstrated a significant decrease in LV volumes compared with the placebo group. Despite a higher number of arrhythmic events in the myoblast-treated patients, the 6-month rates of major cardiac adverse events and of ventricular arrhythmias did not differ significantly between the pooled treatment and placebo groups.
  
  
  CONCLUSIONS
  Myoblast injections combined with coronary surgery in patients with depressed LV function failed to improve echocardiographic heart function. The increased number of early postoperative arrhythmic events after myoblast transplantation, as well as the capability of high-dose injections to revert LV remodeling, warrants further investigation.
authors.affiliation: Département de Chirurgie Cardio-vasculaire, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015 Paris, France. philippe.menasche@egp.aphp.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Menasché
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.forename: Stefan
authors.initials: S
authors.lastname: Janssens
authors.forename: William
authors.initials: W
authors.lastname: McKenna
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
authors.forename: Ludovic
authors.initials: L
authors.lastname: Trinquart
authors.forename: Jean-Thomas
authors.initials: JT
authors.lastname: Vilquin
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Marolleau
authors.forename: Barbara
authors.initials: B
authors.lastname: Seymour
authors.forename: Jérôme
authors.initials: J
authors.lastname: Larghero
authors.forename: Stephen
authors.initials: S
authors.lastname: Lake
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
authors.forename: Scott
authors.initials: S
authors.lastname: Solomon
authors.forename: Michel
authors.initials: M
authors.lastname: Desnos
authors.forename: Albert A
authors.initials: AA
authors.lastname: Hagège
mesh_terms: D000368:Aged; D009202:Cardiomyopathies / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D032448:Myoblasts, Skeletal / Q000637:transplantation*; D017202:Myocardial Ischemia / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D014182:Transplantation, Autologous; D019737:Transplants