Clinical Trial Information

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Clinical Trial Information

The MAGIC study (Myoblast Autologous Grafting in Ischemic Cardiomyopathy) is a Phase II clinical trial being conducted in Europe in patients with heart failure, a condition that affects more than 20 million patients worldwide. This trial was designed to determine whether cell therapy with autologous skeletal myoblasts can replace damaged myocardium cells and restore muscle function following a heart attack, or to safely halt a patient's further progression of ischemic heart failure. Patient enrollment for the trial has been discontinued. Follow-up of patients who have been enrolled to date will be continued and all data specified in the protocol throughout the follow-up period will be collected.

Because the cells involved in growing new heart tissue – cardiomyocytes – have limited regenerative ability in adults, the heart has minimal potential to heal itself after a heart attack occurs. For this reason, cell therapy has been developed as a new strategy to improve the structure and function of the defective myocardium. Investigators in the MAGIC trial harvest a patient’s own skeletal myoblast cells (autologous) prior to bypass surgery through a small biopsy in the leg. These cells are multiplied in the laboratory over approximately 21 days using a proprietary cell-culture technique. This unique technique, developed by MYOSIX, allows very large quantities of myoblasts to be obtained from a small biopsy sample. The investigators then inject the cells into the damaged region of a patient’s heart during a coronary artery bypass operation.

The MAGIC trial builds upon the work of Professor Philippe Menasché (HEGP, Paris, France), Genzyme’s European Principal Investigator. Prof. Menasché was the first (in 2000) to perform an autologous intramyocardial graft of skeletal myoblast. His Phase I study of 10 patients demonstrated the feasibility of autologous skeletal myoblast transplantation in severe ischemic heart failure and the safety information supported continuation to a Phase II study. It also suggested the potential functional efficacy that formed the precursor to the MAGIC trial.

This multi-center Phase II clinical trial was designed to assess the safety and efficacy of two doses of autologous skeletal myoblasts, as compared to placebo, in the treatment of ischemic heart failure. The MAGIC trial is conducted in Europe, including centers in Belgium, Denmark, France, Germany, Italy, and UK, with partial funding from Assistance Publique - Hôpitaux de Paris in France. This study is no longer enrolling patients.

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			DISCLAIMER Please note that the MAGIC (Myoblast Autologous Grafting in Ischemic Cardiomyopathy) phase II clinical trial study being conducted in Europe has recently discontinued enrollment. The study does not involve healthcare professionals or patients in the United States. The information about this clinical trial is therefore intended for healthcare professionals and researchers located outside the United States, its territories and Puerto Rico.



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