Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Mesoblast, Ltd.
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01781390
First received: January 14, 2013
Last updated: December 4, 2014
Last verified: December 2014

January 14, 2013
December 4, 2014
December 2012
December 2016   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
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: 12.5 M Mesenchymal Precursor Cells (MPC)
  • Other: Placebo
  • Other: 25M Mesenchymal Precursor Cells (MPC)
  • Experimental: 12.5M Mesenchymal Precursor Cells (MPC)
    12.5M Mesenchymal Precursor Cell (MPC) administered via IC infusion
    Intervention: Other: 12.5 M Mesenchymal Precursor Cells (MPC)
  • Experimental: 25M Mesenchymal Precursor Cells (MPC)
    25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
    Intervention: Other: 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.
 
Recruiting
225
June 2018
December 2016   (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
Both
18 Years and older
No
Contact: AMICI Clinical Operations Lead +1 212 880 2060 info@mesoblast.com
Netherlands
Belgium,   Australia,   Denmark,   New Zealand
 
NCT01781390
ANG.AMI-IC001
Yes
Mesoblast, Ltd.
Mesoblast, Ltd.
Teva Pharmaceuticals USA
Study Director: Lee Golden, MD Mesoblast, Inc.
Principal Investigator: Eric Duckers, MD UMC Utrecht
Mesoblast, Ltd.
December 2014

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