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

This study is currently recruiting participants.
Verified April 2013 by Angioblast Systems
Sponsor:
Collaborators:
Mesoblast, Inc.
Mesoblast, Ltd.
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Angioblast Systems
ClinicalTrials.gov Identifier:
NCT01781390
First received: January 14, 2013
Last updated: April 29, 2013
Last verified: April 2013
History of Changes

January 14, 2013
April 29, 2013
December 2012
December 2014   (final data collection date for primary outcome measure)
Frequency of the total major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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
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Not Provided
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Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Other: Mesenchymal Precursor Cells (MPC)
  • Other: Placebo
  • Experimental: 12.5M MPCs
    12.5M Mesenchymal Precursor Cell (MPC) administered via IC infusion
    Intervention: Other: Mesenchymal Precursor Cells (MPC)
  • Experimental: 25M MPCs
    25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
    Intervention: Other: 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.
 
Recruiting
225
June 2016
December 2014   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Clinical symptoms consistent with AMI (pain, etc.) from a minimum of 2 to 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
  • Female of child bearing potential willing to use contraception and must have negative pregnancy test upon screening

Key Exclusion Criteria:

  • Prior AMI, known cardiomyopathy, or hospital admission for heart failure (HF)
  • Significant valvular disease
  • Need for staged treatment of coronary artery disease (CAD), or 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
Both
18 Years and older
No
Contact: Priya Raina 212 993 7925 priya.raina@mesoblast.com
Contact: Rebecca Cohen 212 993 7922 rebecca.cohen@mesoblast.com
Australia,   Belgium,   Denmark,   New Zealand
 
NCT01781390
ANG.AMI-IC001
Yes
Angioblast Systems
Angioblast Systems
  • Mesoblast, Inc.
  • Mesoblast, Ltd.
  • Teva Pharmaceuticals USA
Study Director: Peter Adams, MD Mesoblast, Inc.
Principal Investigator: Eric Duckers, MD UMC Utrecht
Angioblast Systems
April 2013

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