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Keep this study
Lead
Cytori Therapeutics
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.
Age
20–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
You may not be if
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
Clareo Health | Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
