The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) Trial
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- Philippe Menasché
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Ottavio Alfieri
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Stefan Janssens
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- William McKenna
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Hermann Reichenspurner
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Ludovic Trinquart
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Jean-Thomas Vilquin
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Jean-Pierre Marolleau
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Barbara Seymour
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Jérôme Larghero
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Stephen Lake
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Gilles Chatellier
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Scott Solomon
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Michel Desnos
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
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- Albert A. Hagège
- From Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Département de Chirurgie Cardio-vasculaire; Université Paris Descartes, Faculté de Médecine; INSERM U633, Laboratoire de Recherches Biochirurgicales, Paris, France (P.M.); Ospedale San Raffaele, Dipartimento Cardiochirugia, Milano, Italy (O.A.); UZ Gasthuisberg, Cardiology Department, Leuven, Belgium (S.J.); The Heart Hospital, London, UK (W.M.); Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für...
Bibliographic Information
- Other Title
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- First Randomized Placebo-Controlled Study of Myoblast Transplantation
Description
<jats:p> <jats:bold> <jats:italic>Background—</jats:italic> </jats:bold> 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. </jats:p> <jats:p> <jats:bold> <jats:italic>Methods and Results—</jats:italic> </jats:bold> This multicenter, randomized, placebo-controlled, double-blind study included patients with left ventricular (LV) dysfunction (ejection fraction ≤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 ( <jats:italic>P</jats:italic> =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. </jats:p> <jats:p> <jats:bold> <jats:italic>Conclusions—</jats:italic> </jats:bold> 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. </jats:p>
Journal
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- Circulation
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Circulation 117 (9), 1189-1200, 2008-03-04
Ovid Technologies (Wolters Kluwer Health)
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Details 詳細情報について
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- CRID
- 1361137044207589632
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- ISSN
- 15244539
- 00097322
- http://id.crossref.org/issn/00097322
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- Data Source
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- Crossref