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DOI: 10.1055/s-2008-1037979
MAGIC (Myoblast Autologous Grafting in Ischaemic Cardiomyopathy) phase II study: The Hamburg experience
Objective: Autologous myoblast transplantation (AMT) is an innovative technique for the treatment of ischaemic cardiomyopathy (ICM). This study evaluates the safety and efficacy of AMT and coronary artery bypass grafting (CABG) for the treatment of ICM (MAGIC Phase II Study, MG Biotherapeutics Inc.).
Materials: At our institution 10 patients were screened and 7 patients (mean age 59±6 years) were included into the multicenter, double-blinded study. Patients were prospectively randomised into high dose (800×106 cells, n=2), low dose (400×106 cells, n=2) or placebo group (n=3). The myoblasts were exclusively injected into the infarct area and surrounding tissue not treated with CABG. Patients were followed-up at 10 days, 1, 3, 6 and 12 months postoperatively. Data collection included echo data (ejection fraction, hypokinetic/akintic segments), brain natriuretic peptide (BNP), and NYHA classification pre-and post-operatively, as well as major adverse cardiac events (MACE) during the follow-up.
Results: There was one MACE in the placebo group due to ventricular fibrillation and ICD firing (after 6 months). At one year follow-up all patients were alive and well. The ejection fraction improved from 31% to 35% (p=0.12), the number of akinetic segments were reduced from 4.2 to 2.4 (p=0.58). Clinically we revealed a slight reduction of the NYHA classification from 1.8±0.7 to 1.7±0.5, BNP levels increased from 242±187 to 456±343 pg/ml. There was no statistically significant difference among groups at follow-up.
Conclusion: From our experience, AMT in combination with CABG is a safe procedure. Transplanted myoblasts did not induce ventricular arrhythmias. Left ventricular function was stabilized but not improved.