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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 : Completed
First Posted : February 1, 2013
Results First Posted : January 18, 2022
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Brief Summary:

This was a double-blind, randomized, placebo-controlled study that was designed to enroll a total of 225 participants with de novo anterior wall acute ST-segment elevation myocardial infarction (STEMI) due to a lesion of the left anterior descending coronary artery undergoing percutaneous coronary intervention (PCI). Eligible participants were to be enrolled and undergo revascularization of the culprit left anterior descending (LAD) coronary artery. The interventional procedure included as dose ranging assessment of intracoronary (IC) delivery of MPC or placebo infused into the stented coronary artery. This study compared two doses of MPCs and a placebo control group. Study participants were randomly assigned in 1:1:1 fashion to receive either 12.5 Million or 25 Million MPCs or placebo (saline). Initially, each group was designed to have approximately 75 patients per treatment group. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population.

The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. Feasibility of the infusion of the investigational agent was assessed by measurement of thrombolysis in myocardial infarction (TIMI) flow and perfusion (1) immediately prior to, (2) during (after approximately 50% of total investigational agent volume infused) and (3) following the investigational agent infusion after successful PCI and stenting. There was no evidence of clinically important coronary microvascular obstruction related to infusion of the investigational agent.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blind, Randomized, Placebo-controlled Clinical Trial of Intracoronary Infusion of Mesenchymal Precursor Cells (MPC) in the Treatment of Patients With ST-Elevation Myocardial Infarction
Actual Study Start Date : March 11, 2013
Actual Primary Completion Date : April 6, 2021
Actual Study Completion Date : April 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received matching-placebo solution 2 milliliters per minute (mL/min) infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.
Other: Placebo
Matching placebo solution for infusion.

Experimental: Mesenchymal Precursor Cells (MPC) 12.5 M
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.
Biological: Mesenchymal Precursor Cells (MPC) 12.5 M
MPC 12.5 M solution for infusion.

Experimental: Mesenchymal Precursor Cells (MPC) 25 M
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
Biological: Mesenchymal Precursor Cells (MPC) 25 M
MPC 25 M solution for infusion.




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 8 years ]
    Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.



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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 acute myocardial infarct (AMI) (pain, etc.) for a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI).
  • De Novo anterior 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, Inc.
Investigators
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Study Director: Fred Grossman, DO Mesoblast, Inc.
  Study Documents (Full-Text)

Documents provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT01781390    
Other Study ID Numbers: ANG.AMI-IC001
2010-020497-41 ( EudraCT Number )
First Posted: February 1, 2013    Key Record Dates
Results First Posted: January 18, 2022
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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. ( Mesoblast, Inc. ):
Acute Myocardial Infarction
STEMI
Heart Attack
AMI
Stem Cells
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases