Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction
This trial is active, not recruiting.
|Condition||acute myocardial infarction|
|Treatments||12.5 m mesenchymal precursor cells (mpc), placebo, 25m mesenchymal precursor cells (mpc)|
|Collaborator||Teva Pharmaceuticals USA|
|Start date||December 2012|
|End date||January 2017|
|Trial size||105 participants|
|Trial identifier||NCT01781390, ANG.AMI-IC001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Frequency of the total major adverse cardiac and cerebrovascular events (MACCE)
time frame: 24 months
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
|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|
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