Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Placebo; Mesenchymal Precursor Cells (MPC) 12.5 M; Mesenchymal Precursor Cells (MPC) 25 M
Intervention description: Matching placebo solution for infusion.; MPC 12.5 M solution for infusion.; MPC 25 M solution for infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Myocardial Infarction; STEMI; Heart Attack; AMI; Stem Cells

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.