Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)

To assess the safety and efficacy 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 percutaneous or surgical revascularization.

Inclusion criteria

• Males or females > 20 and < 80 years of age
• Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
• CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
• On maximal medical therapy for anginal symptoms and/or heart failure symptoms
• Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
• Ejection fraction ≥ 20% and ≤ 45%
• Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
• Left ventricular wall thickness ≥ 8 mm at the target site for cell injection

Exclusion criteria

• Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
• Unstable angina
• LV thrombus, as documented by echocardiography
• Planned staged treatment of CAD or other intervention on the heart
• Platelet count < 100,000/mm3
• WBC < 2,000/mm3
• TIA or stroke within 90 days prior to randomization
• ICD shock within 30 days prior to randomization
• Any condition requiring immunosuppressive medication
• A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
• Revascularization within 60 days prior to randomization
• Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
• Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)
• Hemoglobin ≤ 10.0 g/dL