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Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction (AMICI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01781390
First received: January 14, 2013
Last updated: April 18, 2017
Last verified: September 2016
January 14, 2013
April 18, 2017
December 2012
July 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01781390 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction
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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Biological: 12.5 M Mesenchymal Precursor Cells (MPC)
    MPCs
  • Other: Placebo
    Placebo
  • Biological: 25M Mesenchymal Precursor Cells (MPC)
    MPC
  • Experimental: 12.5M Mesenchymal Precursor Cells (MPC)
    12.5M Mesenchymal Precursor Cell (MPC) administered via IC infusion
    Intervention: Biological: 12.5 M Mesenchymal Precursor Cells (MPC)
  • Experimental: 25M Mesenchymal Precursor Cells (MPC)
    25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
    Intervention: Biological: 25M Mesenchymal Precursor Cells (MPC)
  • Placebo Comparator: Placebo
    Placebo via IC infusion
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
105
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Belgium,   Denmark,   Netherlands,   New Zealand
 
NCT01781390
ANG.AMI-IC001
Yes
Not Provided
No
Not Provided
Mesoblast, Ltd.
Mesoblast, Ltd.
Not Provided
Study Director: Donna Skerrett, MD Mesoblast, Inc.
Principal Investigator: Timothy Henry, MD Cedar-Sinai Heart Institute
Mesoblast, Ltd.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP