Trial DesignRationale and design of Enhanced Angiogenic Cell Therapy in Acute Myocardial Infarction (ENACT-AMI): The first randomized placebo-controlled trial of enhanced progenitor cell therapy for acute myocardial infarction
Section snippets
Study objectives
The primary objectives of ENACT-AMI are to determine whether E-CMM therapy is effective and safe in improving cardiac function following acute MI, and whether endothelial nitric oxide synthase (eNOS) transfected E-CMMs are superior to non-transfected E-CMMs. A secondary objective is to determine whether the efficacy of E-CMM therapy depends on the timing of cell delivery (5-10 days vs 11-30 days post-MI).
Study design and setting
ENACT-AMI is a phase IIb, double-blind, parallel, randomized placebo-controlled trial, with
Discussion
ENACT-AMI will study the efficacy of cell therapy for acute MI using a cell manufacturing protocol that results in a population of well-characterized endothelial-like, culture modified MNCs (or early EPCs), which have been shown to have potent regenerative activity in lung vascular disease, hind limb ischemia and MI in preclinical models.17, 24, 25 To the best of our knowledge, this will be the first clinical trial to use gene-enhanced cell therapy for cardiac disease, by exploring the
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