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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01781390
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.

Tracking Information
First Submitted Date  ICMJE January 14, 2013
First Posted Date  ICMJE February 1, 2013
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE December 2012
Actual Primary Completion Date July 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
The primary efficacy endpoint is the change in left ventricular (LV) end-systolic volume (LVESV) as assessed by cardiac MRI from baseline to 6 months post investigational agent infusion [ Time Frame: 6 months ]
The objective is to assess LV chamber remodeling at 6 months post index STEMI.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
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.
Change History Complete list of historical versions of study NCT01781390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction
Official Title  ICMJE 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
Brief Summary This is a double blind, randomized, placebo controlled study that will enroll 105 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.
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.

Evaluation for safety will be performed for up to 24 months post infusion. Subjects will undergo cardiac imaging (using cMRI and 2D-echocardiography), Holter monitoring, clinical evaluations, and laboratory testing. Clinical evaluations and safety laboratory testing will be performed post infusion of investigational agent as outlined in the study protocol.

Subjects enrolled in Sweden who consent for additional safety follow-up will be followed for safety assessments at 36, 48, and 60 months post-infusion of investigational agent.

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 until subject enrolment is closed

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Biological: 12.5 M Mesenchymal Precursor Cells (MPC)
    MPCs
  • Other: Placebo
    Placebo
  • Biological: 25M Mesenchymal Precursor Cells (MPC)
    MPC
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 13, 2016)
105
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2013)
225
Estimated Study Completion Date  ICMJE April 2021
Actual Primary Completion Date July 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Belgium,   Denmark,   Netherlands,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT01781390
Other Study ID Numbers  ICMJE ANG.AMI-IC001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mesoblast, Ltd.
Study Sponsor  ICMJE Mesoblast, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donna Skerrett, MD Mesoblast, Inc.
Principal Investigator: Timothy Henry, MD Cedar-Sinai Heart Institute
PRS Account Mesoblast, Ltd.
Verification Date February 2019

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