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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
  Purpose
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.

Condition Intervention Phase
Acute Myocardial Infarction
Biological: 12.5 M Mesenchymal Precursor Cells (MPC)
Other: Placebo
Biological: 25M Mesenchymal Precursor Cells (MPC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • 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.


Enrollment: 105
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)
Arms Assigned Interventions
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)
MPCs
Experimental: 25M Mesenchymal Precursor Cells (MPC)
25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
Biological: 25M Mesenchymal Precursor Cells (MPC)
MPC
Placebo Comparator: Placebo
Placebo via IC infusion
Other: Placebo
Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781390

Sponsors and Collaborators
Mesoblast, Ltd.
Investigators
Study Director: Donna Skerrett, MD Mesoblast, Inc.
Principal Investigator: Timothy Henry, MD Cedar-Sinai Heart Institute
  More Information

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01781390     History of Changes
Other Study ID Numbers: ANG.AMI-IC001
Study First Received: January 14, 2013
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mesoblast, Ltd.:
Acute Myocardial Infarction
STEMI
Heart Attack
AMI
Stem Cells

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2017