Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction (AMICI)
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|ClinicalTrials.gov Identifier: NCT01781390|
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : January 18, 2022
Last Update Posted : June 23, 2022
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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.
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
|Study Director:||Fred Grossman, DO||Mesoblast, Inc.|