Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
NCT ID: NCT02052427
Last Updated: 2016-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
3 participants
INTERVENTIONAL
2014-01-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ADRCs
Adipose-Derived Regenerative Cells (ADRCs) processed by the Celution System:
* 0.8 x 10\^6 cells/kg body weight (not to exceed 80.0 x 10\^6 cells)
* Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections
Celution System
ADRCs processed by the Celution System for reintroduction into the myocardium
Placebo
Placebo - Physiological Solution
* Inactive substance (Lactated Ringers + autologous blood)
* Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections
Placebo
Physiological solution made of Lactated Ringers solution and a small amount (\<1mL) of autologous blood
Interventions
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Celution System
ADRCs processed by the Celution System for reintroduction into the myocardium
Placebo
Physiological solution made of Lactated Ringers solution and a small amount (\<1mL) of autologous blood
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
80 Years
ALL
No
Sponsors
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Cytori Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Emerson C. Perin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Stem Cell Center at Texas Heart Institute
Timothy Henry, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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University Hospital Case Medical Center
Cleveland, Ohio, United States
Countries
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References
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Henry TD, Pepine CJ, Lambert CR, Traverse JH, Schatz R, Costa M, Povsic TJ, David Anderson R, Willerson JT, Kesten S, Perin EC. The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction. Catheter Cardiovasc Interv. 2017 Feb 1;89(2):169-177. doi: 10.1002/ccd.26601. Epub 2016 Sep 23.
Other Identifiers
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ATHENA II
Identifier Type: -
Identifier Source: org_study_id