AMICI

Phase 2

Official Title: A Prospective, Double Blind, Randomized, Placebo-controlled Clinical Trial of Intracoronary Infusion of Immunoselected, Bone Marrow-derived Stro3 Mesenchymal Precursor Cells (MPC) in the Treatment of Patients With ST-elevation Myocardial Infarction

ClinicalTrials.gov Identifier: NCT01781390

Purpose

This is a double blind, randomized, placebo controlled study that will enroll 225 subjects with previously untreated (de novo) anterior myocardial infarction (heart attack) due to a lesion of the left anterior descending (LAD) coronary artery undergoing percutaneous coronary intervention  (PCI). Eligible subjects will be enrolled and undergo revascularization (treatment to open up) the culprit LAD followed by an intracoronary (IC) delivery of the assigned treatment, infused into the stented culprit artery. The study will determine the safety and feasibility of the IC infusion of investigational MPCs in this patient population either,

• 5 M Mesenchymal Precursor Cells (MPC)
• Placebo
• 25M Mesenchymal Precursor Cells (MPC)

Primary Outcome Measures:

Frequency of the total major adverse cardiac and cerebrovascular events (MACCE)