Clinical MAGIC Results

The MAGIC trial (Myoblast Autologous Grafting in Ischemic Cardiomyopathy) is a Phase II clinical trial conducted in Europe with centers in Belgium, France, Germany, Italy, and UK. MAGIC enrolled patients with congestive heart failure who have had a myocardial infarction, a condition that affects more than 20 million patients worldwide. This trial was designed to test the hypothesis that cell therapy with autologous skeletal myoblasts placed within infarcted, scarred muscle, could restore either heart muscle function following a heart attack, or slow the progressive decline in cardiac function over time that often follows irreversible damage to a large segment of ventricular muscle.

The MAGIC trial builds upon the work of Professor Philippe Menasché (HEGP, Paris, France), the Principal Investigator of this trial. Prof. Menasché was the first to perform autologous intramyocardial grafting of skeletal myoblasts in patients undergoing cardiac surgery. A Phase I study of 10 patients with advanced ischemic cardiomyopathy documented the feasibility of autologous skeletal myoblast transplantation in severe ischemic heart failure. The safety information accrued in this Phase II trial supported continuation to a Phase II study, termed the MAGIC trial.

The MAGIC trial enrolled 97 patients with a history of myocardial infarction, who had an area of akinetic, scar tissue and significant left ventricular dysfunction. Patients were randomized to either placebo, 400 million or 800 million of autologous skeletal myoblasts, which had been generated ex vivo over a 21 day period following a muscle biopsy from a donor site in a leg. These cells were cultured and grown in vitro in a laboratory over 21 days using a proprietary GMP cell-culture technique developed by MYOSIX Inc. The expanded, cultured autologous skeletal myoblasts were then injected into 30 sites in and around a pre-specified region of the scar tissue during a scheduled coronary artery bypass surgery. An automatic cardioverter-defibrillator was implanted in all patients prior to discharge.

This multi-center Phase II clinical trial was designed to assess the safety and efficacy of two doses of autologous skeletal myoblasts, when compared to placebo injections, in the treatment of ischemic heart failure. Six month follow-up data from the Phase I trial were presented by Prof. Menasché at the American Heart Association meeting in 2006.

The primary efficacy endpoint was not attained, because there were no significant differences in either left ventricular ejection fraction or regional wall motion score – both measured by echocardiography - in the treated groups versus the placebo group at month 6 when compared to baseline ventricular function.

Despite not achieving its primary endpoint, the MAGIC trial data did document a statistically significant decrease in left ventricular volumes in patients who had received the high (i.e., 800 million cells) dose of cells, when compared to the placebo group.

Regarding safety, the incidence of Major Adverse Cardiac Events (i.e., MACE, i.e., stroke, congestive heart failure, myocardial infarction, all cause mortality, resuscitated sudden death), and ventricular arrhythmia (VA) were assessed for the treatment and placebo groups at Day 30 and after 6 months. The results showed no statistically significant differences between the treatment and the placebo groups in terms of safety outcomes (i.e., MACE, including the incidence of serious ventricular arrhythmias), nor were there significant differences between the two active treatment groups in MACE events, at any time points.

In summary, these data suggest that implantation of autologous skeletal myoblasts into both scarred and peri-infarct muscle is feasible and appears to be well tolerated.  Even though it did not reach its primary endpoint, the MAGIC study provides evidence that autologous skeletal myoblast transplant may have beneficial effects on ventricular remodeling at the highest dose employed in this study (i.e., 800 million cells) at 6 months  An additional clinical trial(s) will be required,  both to confirm the preliminary efficacy signal observed in the high dose autologous skeletal myoblast cohort in this study, and to provide additional evidence of the safety in patients with advanced ischemic cardiomyopathy.

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