Original articleCardiovascularMyocardial Assistance by Grafting a New Bioartificial Upgraded Myocardium (MAGNUM Trial): Clinical Feasibility Study
Section snippets
Study Design
The study was a nonrandomized, controlled phase I clinical trial. Eligibility for inclusion was based on (1) systolic left ventricular (LV) dysfunction, as reflected by an echocardiographic LV ejection fraction (LVEF) of 35% or less; (2) a history of myocardial infarction with a residual akinetic and nonviable scar; and (3) an indication for concomitant single off-pump coronary artery bypass graft surgery (OP-CABG). These patients were free of angina symptoms, there was no indication of
Results
In this phase I nonrandomized trial, after consideration of inclusion and exclusion criteria, we enrolled 20 consecutive patients (90% male) presenting with chronic ischemic heart disease. The age of the infarcts was 8.2 ± 3.5 months (range, 3 to 25). The baseline characteristics were comparable in both groups (Table 1).
Bone marrow was aspirated from the posterior iliac crest during a brief general anesthesia with midazolam and etomidate; no bleeding complications at the harvest site were
Comment
This study attempts to demonstrate the feasibility and safety of simultaneous intramyocardial injection of BMC and fixation of a BMC-seeded matrix onto the epicardium of infarcted ventricles. The cardiac connective tissue is mainly composed of collagen, with smaller amounts of elastin, laminin, and fibronectin. There are two main types of collagen fibers in the normal adult heart, types I and III, produced by fibroblasts and myofibroblasts. Experimental observations have shown that in the
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