Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction

Summary

Participation Requirements

Description

This is a prospective, double-blind, randomized, placebo-controlled study that will enroll approximately 105 subjects with de novo anterior STEMI due to a lesion involving LAD coronary artery who undergo primary PCI at approximately 25 clinical study sites. This study will compare two doses of MPCs ...

This is a prospective, double-blind, randomized, placebo-controlled study that will enroll approximately 105 subjects with de novo anterior STEMI due to a lesion involving LAD coronary artery who undergo primary PCI at approximately 25 clinical study sites. This study will compare two doses of MPCs and a placebo control group. Study subjects will be randomly assigned in 1:1:1 fashion to receive either 12.5 Million or 25 Million MPCs or placebo (saline). Each group will have approximately 35 subjects. Potential subjects will be approached by a site investigator prior to PCI and must sign an informed consent form before initiation of the cardiac catheterization procedure in order to participate in this trial. Following successful and uneventful PCI and stenting of the culprit LAD lesion, the subjects will be randomized. The randomization and treatment assignment will be obtained from an interactive voice-response system (IVRS/interactive web response system (IWRS)). The following stratification for duration of cardiac ischemia will be performed to ensure balanced randomization across the treatment groups: ≤2 hours >2 hours to ≤6 hours >6 to ≤12 hours Eligible subjects will receive intracoronary delivery of the assigned treatment infused via a microcatheter into the stented culprit artery. After approximately 50% of the intracoronary infusion of investigational agent has been completed, an angiographic determination of coronary flow will be performed. The following guidelines will be used to determine if the remaining investigational agent should be infused: The study infusion should be continued if either TIMI 2 or TIMI 3 flow is present in the absence of ALL of the following; Sustained hypotension not responsive to fluid administration; Clinical signs/symptoms indicating an acute cerebrovascular event; Re-elevation of ST-segments if previously resolved with PCI; Onset of the subject's symptoms of myocardial ischemia unresponsive to appropriate interventions; Two episodes of sustained ventricular tachycardia (VT)/ventricular fibrillation (VF) requiring cardioversion (infusion can continue if a single episode of sustained VT/VF requiring cardioversion occurred). If for any reason, the site investigator withdraws a randomized subject prior to infusion of the investigational agent, the reason for early termination and data from the screening visit will be entered into the eCRF by the study site. The subject will not remain in the study. If for any reason, a subject's study infusion is halted due to safety considerations, the subject will remain in the study. A subject who prematurely withdraws from the study, post- study infusion will remain in the study. Evaluation for safety will be performed for up to 24 months post infusion. Subjects will undergo cardiac imaging (using cMRI and 2D-echocardiography), Holter monitoring, clinical evaluations, and laboratory testing. Clinical evaluations and safety laboratory testing will be performed post infusion of investigational agent as outlined in the study protocol. Subjects enrolled in Sweden who consent for additional safety follow-up will be followed for safety assessments at 36, 48, and 60 months post-infusion of investigational agent. An independent Data Monitoring Safety Board (DSMB) will review all relevant acute peri-procedural data, serious adverse events (SAE), other adverse events (AE), and efficacy data (if requested) periodically until subject enrolment is closed

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