Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia

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 percutaneous or surgical revascularization.

Key Inclusion Criteria:

1. Males or females 20-80 years of age

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

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 (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate < 110;
Pulse-Oxygen > 95)

6. Ejection fraction ≤ 45

7. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection,
confirmed by 2D contrast echo within 4 weeks prior to enrollment, free of thrombus

Key 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 of randomization

9. Any condition requiring immunosuppressive medication

10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 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) prior to
randomization