The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) trial: first randomized placebo-controlled study of myoblast transplantation
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The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) trial: first randomized placebo-controlled study of myoblast transplantation. / Menasché, Philippe; Alfieri, Ottavio; Janssens, Stefan; McKenna, William; Reichenspurner, Hermann; Trinquart, Ludovic; Vilquin, Jean-Thomas; Marolleau, Jean-Pierre; Seymour, Barbara; Larghero, Jérôme; Lake, Stephen; Chatellier, Gilles; Solomon, Scott; Desnos, Michel; Hagège, Albert A.
in: CIRCULATION, Jahrgang 117, Nr. 9, 04.03.2008, S. 1189-1200.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) trial: first randomized placebo-controlled study of myoblast transplantation
AU - Menasché, Philippe
AU - Alfieri, Ottavio
AU - Janssens, Stefan
AU - McKenna, William
AU - Reichenspurner, Hermann
AU - Trinquart, Ludovic
AU - Vilquin, Jean-Thomas
AU - Marolleau, Jean-Pierre
AU - Seymour, Barbara
AU - Larghero, Jérôme
AU - Lake, Stephen
AU - Chatellier, Gilles
AU - Solomon, Scott
AU - Desnos, Michel
AU - Hagège, Albert A
PY - 2008/3/4
Y1 - 2008/3/4
N2 - 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.METHODS AND 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.
AB - 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.METHODS AND 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.
KW - Aged
KW - Cardiomyopathies/epidemiology
KW - Double-Blind Method
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Myoblasts, Skeletal/transplantation
KW - Myocardial Ischemia/epidemiology
KW - Transplantation, Autologous
KW - Transplants
U2 - 10.1161/CIRCULATIONAHA.107.734103
DO - 10.1161/CIRCULATIONAHA.107.734103
M3 - SCORING: Journal article
C2 - 18285565
VL - 117
SP - 1189
EP - 1200
JO - CIRCULATION
JF - CIRCULATION
SN - 0009-7322
IS - 9
ER -