The ATHENA Clinical Trial

Overview

Status: Not yet recruiting
Keywords: Stem Cell , Heart , Coronary Artery Disease , Ejection Fraction , ischemic heart disease
IRB Number: 00065906
Specialty: Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: Heart Stem Cell Therapy

Brief Summary

The objective of the ATHENA Clinical Trial is to assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for surgical or interventional revascularization.

 

Principal Investigator: Amit Patel
Department: Cardiothoracic Divison
Co Investigator: Anwar Tandar
Co Investigator: Rodney Badger

Contact Information

Name:Matthew Brobeck
Phone: 8015856743
Email: matthew.brobeck@hsc.utah.edu

Inclusion Criteria

Subjects will be enrolled into this study only if they meet ALL of the following criteria:

  1. Males or females > 20 and < 80 years of age
  2. Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area:
    • No CABG: (no suitable conduit, or history of graft failure OR small distal vessels OR surgical risk)
    • No PCI: (occluded vessels fed by collaterals OR small vessels, e.g., diabetes OR marked tortuocity, calcification, or CTO)
  3. Ejection Fraction ≥ 20% and < 45%
  4. Inducible ischemia using an objective assessment of ischemia within 1 year of screening (e.g., exercise ECG changes, SPECT)
  5. CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
  6. On maximal medical therapy. Maximal medical therapy for anginal symptoms is defined as a medical regimen that generally includes the maximal tolerated dose of at least two anti-angina medications such as beta blockers, nitrates, or calcium channel blockers. One anticipates using a beta blocker or calcium channel blocker to reduce heart rate to 50–60 beats per minute and systolic blood pressure to 100–115 mm/Hg in patients with angina or as tolerated clinically in order to evaluate them for limiting angina or angina that interferes with the lifestyle the patient wishes to lead. Patients who tolerate only one class of medications may still be included according to clinical judgment. Maximal medical therapy for heart failure symptoms includes beta-blockers (either a beta 1 blocker, such as metaprolol or non-specific beta blocker, such as carvedilol), ACE-1 or ARB (if creatinine < 2.5) + diuretics. Patients with LVEFs < to 35%, sinus rhythm, and NYHA Functional Class III or ambulatory class IV symptoms despite recommended, optimal medical therapy and who have cardiac dyssynchrony, which is currently defined as QRS duration > 0.12 ms, should receive cardiac resynchronization therapy unless contraindicated.
  7. Hemodynamic stability (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate <110; Pulse-Oxygen >95%)
  8. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2D Contrast Echo within 4 weeks prior to enrollment, and free of thrombus
  9. Ability to safely undergo liposuction that will result in the harvest of a sufficient quantity of adipose tissue (up to 450 mL)
  10. Negative urine pregnancy test (females only)
  11. Women of childbearing potential agree to use two forms of contraceptive (i.e. condoms & oral contraceptive or diaphragm)
  12. Able to provide written informed consent

Exclusion Criteria

  1. Atrial fibrillation or flutter without a pace maker that guarantees a stable
    heart rate
  2. Unstable angina
  3. LV thrombus, as documented by echocardiography or left ventriculogram
  4. Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization
  5. Severe aortic or mitral valvular disease that would preclude safe entry of the catheter into the left ventricle
  6. Presence of prosthetic aortic or mitral valves
  7. Presence of aortic dissection
  8. Planned staged treatment of CAD or other intervention on the heart
  9. Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to liposuction
  10. Platelet count < 100,000/mm3
  11. WBC < 2,000/mm3
  12.  TIA or stroke within 90 days prior to randomization
  13.  ICD shock within 30 days of randomization
  14. Presence of sustained ventricular tachycardia (30 or more seconds) on 24 hour Holter monitor or ECG performed during screening period
  15. A bleeding diathesis defined as an INR ≥ 2.0 in the absence of warfarin therapy
  16. A history of malignancy in the last 5 years excluding basal cell carcinoma that has been surgically removed with proof of clean surgical margins
  17. Known history of HIV, or has active Hepatitis B or active Hepatitis C
  18. Any condition requiring immunosuppressive medication
  19. A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization (ACS is defined as the presence of chest pain characteristic for angina, dynamic electrocardiography changes of ST segment depression or elevation and/or serum elevation of troponin I or T > 3X ULN, according to local laboratory)
  20. Revascularization within 60 days prior to randomization
  21. Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately. (If only reason patient is unable to walk on treadmill is class IV angina, then patient can be included.)
  22. Participation in another investigational device or drug study, including continued access phase, within the 30 days preceding randomization
  23. Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and /or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN) prior to randomization
  24. Chronic renal insufficiency as defined as a serum creatinine > 2.5 mg/dL or requires dialysis
  25. Hemoglobin ≤ 10.0 g/dL
  26.  Any condition that in the judgment of the Investigator would be a contraindication to screening and enrollment procedures, follow-up procedures or NOGASTAR® mapping and/or MYOSTAR Injections (per NOGASTAR®/MYOSTAR Instructions For Use).