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Objective: The MAGIC Phase II Study is the first multicenter, prospective randomised, double-blinded study evaluating the safety and efficacy of two doses of autologous skeletal myoblast transplantation as compared to placebo for the treatment of ischemic cardiomyopathy (ICM) (MAGIC Phase II Study, MG Biotherapeutics Inc.).
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Jens Brickwedel, MD, Philippe Menasche, MD,PhD, Ottavio Alfieri, MD, Stefan Janssens, MD,PhD, William McKenna, MD,PhD, Dieter H. Boehm, MD,PhD, Hermann Reichenspurner, MD,PhD.
Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
Method: So far 97patients have been included in several European centers and received either myoblast (high dosage: 800x106 cells, 30 patients (group hd), low dosage: 400x106 cells, 33 patients (group ld) or placebo (34patients, group pl)) injections into the scar tissue and perinfarction zone as adjunct procedure to CABG. Patients are followed up at 10 days, 1, 3, 6, 12 and 24 months. Follow-up was completed at 6 months in 80% (24/30) in group hg, 61% (20/33) in group ld and 79% (27/34) in group pl.
Prespecified endpoints are incidence of MACE and ventricular arrhythmias. Primary efficacy endpoints are recovery of contraction of previously akinetic segments and change of LVEF as assessed by echocardiography in a central core lab and by MUGA scan at specific sites. The left ventricular volumes (LVEDV and LVESV) are calculated as secondary endpoint. Seconary endpoint is change in LV remodeling, inferred from end-systolic and end-diastolic volume measurements.
Results: There were no significant differences in patient and procedure characteristics between the groups. At 30 d and six month follow-up there were no significant differences in MACE and /or ventricular arrhythmias.
The LVEF (assessed by MUGA scan) as well as the LVEDV and the LVESV were significantly improved in group hd vs pl (p=0.04, p=0.006, p=0.008 respectively). There were no significant changes in the LVEF (evaluated with echocardiography) and in the regional wall motion analysis.
Conclusion: Autologous skeletal myoblast transplantation is a safe and potentially efficacious procedure for the treatment of ICM. In particular there were no differences in incidence of ventricular arrhythmias between the groups. The study was limited by relatively small patient numbers and short follow-up.
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