Clinical Trial: The Enhanced Angiogenic Cell Therapy - Acute Myocardial Infarction Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase IIb, Randomized, Double-blind, Placebo Controlled Study Using Transplantation of Autologous Early Endothelial Progenitor Cells(EPCs) for Patients Who Have Suffered Acute Myocardial Infarction

Brief Summary: This will be the first clinical trial to include a strategy designed to enhance the function of autologous progenitor cells by overexpressing eNOS, and the first to use combination gene and cell therapy for the treatment of cardiac disease.

Detailed Summary:

Introduction:

  • Despite the widespread use of pharmacological and/or interventional reperfusion therapies, recovery of cardiac function in myocardial infarction patients is often modest or in some cases absent. Unlike classical re-perfusion therapies, which must be delivered before irreversible cardiac damage has occurred, the use of progenitor cells could potentially restore functional tissue in regions that otherwise would form only scar. A number of clinical trials have been performed, mainly using autologous bone marrow cells, and these suggest a significant albeit modest improvement in cardiac function post MI. However, a major limitation of autologous cell therapy in patients with cardiovascular disease is the deleterious influence of age and other cardiac risk factors on progenitor cell activity, which may limit greatly the potential efficacy of this promising approach.

Trial Design:

  • The Enhanced Angiogenic Cell Therapy - Acute Myocardial Infarction (ENACT-AMI) trial is a Canadian, 5-center, phase IIb, double-blind, parallel, randomized placebo controlled trial assessing the safety and efficacy of cell and gene therapy for patients with moderate to large anterior STEMI and who have undergone re-vascularization with stent implantation to the infarct related artery (IRA). The anticipated recruitment target is 100 patients over a two-year period.
  • Consenting participants who qualify during the screening process, will undergo apheresis. Randomization, through a web-based system will take place immediately after successful apheresis. The cell collection samples will be sent to a cell manufacturing facility for manufacturing according to the treatment allocation of: a)Pla
    Sponsor: Ottawa Hospital Research Institute

    Current Primary Outcome: Assessment of Global LVEF [ Time Frame: Baseline to 6 months ]

    1. A change in global left ventricular ejection fraction by cardiac MRI between those treated with cell/gene enriched EPCs versus placebo
    2. Change in global left ventricular ejection fraction by cardiac MRI between those treated with non-transfected autologous EPCs versus eNOS transfected EPCs.


    Original Primary Outcome: To assess changes from baseline in global LVEF, regional wall motion, wall thickening and infarct volume by cardiac MRI [ Time Frame: Six months ]

    Current Secondary Outcome:

    • Assessment of: Cardiac wall motion and volumes [ Time Frame: Baseline to 6 months ]
      1. Change in regional wall motion and regional wall thickening by cardiac MRI between the above patient groups
      2. Change in echocardiographic assessment of LVEF, infarct size and ventricular volumes between the above patient groups
    • Time To Clinical Worsening (TTCW) [ Time Frame: Baseline to 6 months ]
      Quality of Life Measures: Participants will complete SF-36 and DASI questionnaires at baseline, 3 and 6 months.
    • Safety Measurements [ Time Frame: Baseline to 6 months ]
      1. Clinically significant changes in CK and troponin more than 24 hours post delivery
      2. Clinically significant changes in ECG
      3. Assessment of major acute cardiac events
      4. Evidence of any systemic embolization during the hospitalization period
      5. Need for revacularization procedures


    Original Secondary Outcome:

    • To assess changes from baseline of Echocardiographic LVEF and ventricular volumes [ Time Frame: Six months ]
    • To assess time to clinical worsening (death, hospitalization for angina or reinfarction) [ Time Frame: 6 months ]
    • To assess any changes from baseline in quality of life (SF-36v2 and DASI) [ Time Frame: 6 months ]


    Information By: Ottawa Hospital Research Institute

    Dates:
    Date Received: July 7, 2009
    Date Started: July 2013
    Date Completion: December 2016
    Last Updated: March 24, 2016
    Last Verified: March 2016