Overview

This trial is active, not recruiting.

Condition acute myocardial infarction
Treatments 12.5 m mesenchymal precursor cells (mpc), placebo, 25m mesenchymal precursor cells (mpc)
Phase phase 2
Sponsor Mesoblast, Ltd.
Collaborator Teva Pharmaceuticals USA
Start date December 2012
End date January 2017
Trial size 105 participants
Trial identifier NCT01781390, ANG.AMI-IC001

Summary

This is a double blind, randomized, placebo controlled study that will enroll 225 subjects with de novo anterior myocardial infarction due to a lesion of the left anterior descending coronary artery undergoing PCI. Eligible subjects will be enrolled and undergo revascularization of 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
12.5M Mesenchymal Precursor Cell (MPC) administered via IC infusion
12.5 m mesenchymal precursor cells (mpc)
MPCs
(Experimental)
25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
25m mesenchymal precursor cells (mpc)
MPC
(Placebo Comparator)
Placebo via IC infusion
placebo
Placebo

Primary Outcomes

Measure
Frequency of the total major adverse cardiac and cerebrovascular events (MACCE)
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Clinical symptoms consistent with AMI (pain, etc.) for a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI) - De Novo anterior Acute Myocardial Infarct (AMI) - Successful revascularization of the culprit lesion Key Exclusion Criteria: - Prior AMI, known cardiomyopathy, or hospital admission for heart failure (HF) - Significant valvular disease - Need for other interventional or surgical procedure to treat heart disease (planned or scheduled) - Cardiogenic shock or hemodynamic instability within 24 hours of randomization - Prior PCI to LAD - Pacemaker, ICD (Implantable Cardioverter Defibrillator), or any other contra-indication for cardiac MRI - Prior or current participation in any stem cell study or any other investigational trial in the past 30 days

Additional Information

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
Principal investigator Eric Duckers, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mesoblast, Ltd..