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

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ClinicalTrials.gov Identifier: NCT01781390
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.

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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : December 2012
Actual Primary Completion Date : July 17, 2018
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781390


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

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01781390     History of Changes
Other Study ID Numbers: ANG.AMI-IC001
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

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