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
  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
Other: 12.5 M Mesenchymal Precursor Cells (MPC)
Other: Placebo
Other: 25M Mesenchymal Precursor Cells (MPC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

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 ] [ 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.


Estimated Enrollment: 225
Study Start Date: December 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2016 (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
Other: 12.5 M Mesenchymal Precursor Cells (MPC)
Experimental: 25M Mesenchymal Precursor Cells (MPC)
25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
Other: 25M Mesenchymal Precursor Cells (MPC)
Placebo Comparator: Placebo
Placebo via IC infusion
Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Contacts
Contact: AMICI Clinical Operations Lead +1 212 880 2060 info@mesoblast.com

Locations
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Eric Duckers         
Sponsors and Collaborators
Mesoblast, Ltd.
Teva Pharmaceuticals USA
Investigators
Study Director: Lee Golden, MD Mesoblast, Inc.
Principal Investigator: Eric Duckers, MD UMC Utrecht
  More Information

No publications provided

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: December 4, 2014
Health Authority: Australia: Human Research Ethics Committee
Austria: Agency for Health and Food Safety
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on August 30, 2015