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:

1. Males or females > 20 and < 80 years of age

2. Significant multi-vessel coronary artery disease not amenable to percutaneous or
surgical revascularization

3. CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III

4. On maximal medical therapy for anginal symptoms and/or heart failure symptoms

5. Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)

6. Ejection fraction ≥ 20% and ≤ 45%

7. Inducible ischemia using an objective assessment of ischemia within 1 year of
screening (i.e. exercise ECG changes, SPECT)

8. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection

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

4. Planned staged treatment of CAD or other intervention on the heart

5. Platelet count < 100,000/mm3

6. WBC < 2,000/mm3

7. TIA or stroke within 90 days prior to randomization

8. ICD shock within 30 days prior to randomization

9. Any condition requiring immunosuppressive medication

10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days
prior to randomization

11. Revascularization within 60 days prior to randomization

12. Inability to walk on a treadmill except for class IV angina patients who will be
evaluated separately

13. Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine
aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)

14. Hemoglobin ≤ 10.0 g/dL