Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction (AMICI)
|Acute Myocardial Infarction||Biological: 12.5 M Mesenchymal Precursor Cells (MPC) Other: Placebo Biological: 25M Mesenchymal Precursor Cells (MPC)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, DB, Randomized, Placebo-controlled Clinical Trial of IC Infusion of Mesenchymal Precursor Cells (MPC) in the Treatment of Patients With ST-elevation Myocardial Infarction|
- Frequency of the total major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 24 months ]Occurrence of MACCE events including cardiac death, myocardial infarction, target vessel revascularization, stroke, new or worsening congestive heart failure during index hospitalization and cardiac hospitalizations due to congestive heart failure.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Experimental: 12.5M Mesenchymal Precursor Cells (MPC)
12.5M Mesenchymal Precursor Cell (MPC) administered via IC infusion
Biological: 12.5 M Mesenchymal Precursor Cells (MPC)
Experimental: 25M Mesenchymal Precursor Cells (MPC)
25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
Biological: 25M Mesenchymal Precursor Cells (MPC)
Placebo Comparator: Placebo
Placebo via IC infusion
This is a prospective, double-blind, randomized, placebo-controlled study that will enroll approximately 105 subjects with de novo anterior STEMI due to a lesion involving LAD coronary artery who undergo primary PCI at approximately 25 clinical study sites.
This study will compare two doses of MPCs and a placebo control group. Study subjects will be randomly assigned in 1:1:1 fashion to receive either 12.5 Million or 25 Million MPCs or placebo (saline). Each group will have approximately 35 subjects.
Potential subjects will be approached by a site investigator prior to PCI and must sign an informed consent form before initiation of the cardiac catheterization procedure in order to participate in this trial. Following successful and uneventful PCI and stenting of the culprit LAD lesion, the subjects will be randomized. The randomization and treatment assignment will be obtained from an interactive voice-response system (IVRS/interactive web response system (IWRS)). The following stratification for duration of cardiac ischemia will be performed to ensure balanced randomization across the treatment groups:
- ≤2 hours
- >2 hours to ≤6 hours
- >6 to ≤12 hours
Eligible subjects will receive intracoronary delivery of the assigned treatment infused via a microcatheter into the stented culprit artery.
After approximately 50% of the intracoronary infusion of investigational agent has been completed, an angiographic determination of coronary flow will be performed. The following guidelines will be used to determine if the remaining investigational agent should be infused:
• The study infusion should be continued if either TIMI 2 or TIMI 3 flow is present in the absence of ALL of the following:
- Sustained hypotension not responsive to fluid administration;
- Clinical signs/symptoms indicating an acute cerebrovascular event;
- Re-elevation of ST-segments if previously resolved with PCI;
- Onset of the subject's symptoms of myocardial ischemia unresponsive to appropriate interventions;
- Two episodes of sustained ventricular tachycardia (VT)/ventricular fibrillation (VF) requiring cardioversion (infusion can continue if a single episode of sustained VT/VF requiring cardioversion occurred).
If for any reason, the site investigator withdraws a randomized subject prior to infusion of the investigational agent, the reason for early termination and data from the screening visit will be entered into the eCRF by the study site. The subject will not remain in the study. If for any reason, a subject's study infusion is halted due to safety considerations, the subject will remain in the study. A subject who prematurely withdraws from the study, post- study infusion will remain in the study. Subjects will be followed for up to 24 months and will undergo cardiac imaging using cMRI and 2D-echocardiography, Holter monitoring, clinical evaluation, and laboratory testing. Evaluations will be performed at 6, 12, 18 and 24 hours post infusion of investigational agent, during the index hospitalization as well as at 14 and 30 days and 3, 6, 12, 18, and 24 months after the procedure as outlined in Table 2 Schedule of Assessments and Procedures.
An independent Data Monitoring Safety Board (DSMB) will review all relevant acute peri-procedural data, serious adverse events (SAE), other adverse events (AE), and efficacy data (if requested) periodically dependent on subject enrollment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781390
|Study Director:||Donna Skerrett, MD||Mesoblast, Inc.|
|Principal Investigator:||Timothy Henry, MD||Cedar-Sinai Heart Institute|