Phase 2
N=106
Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction
Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01781390 ↗Enrolled (actual)
106
Serious AEs
42.7%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 28; 30; 31; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Other); Mesenchymal Precursor Cells (MPC) 12.5 M (Biological); Mesenchymal Precursor Cells (MPC) 25 M (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mesoblast, Inc.
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
28; 30; 31; 14; 16; 14 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01781390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.