Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
NCT ID: NCT01556022
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
28 participants
INTERVENTIONAL
2012-06-30
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
TRIPLE
Study Groups
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ADRCs processed by the Celution System
400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
ADRCs processed by the Celution System
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.
Lactated Ringers and Subject's blood
Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.
Placebo Comparator: Lactated Ringer's and Subject's Blood
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.
Interventions
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ADRCs processed by the Celution System
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.
Placebo Comparator: Lactated Ringer's and Subject's Blood
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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 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
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 Perin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas Heart Institute, Houston, TX
Timothy Henry, MD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis Heart Institute Foundation, Minneapolis, MN
Locations
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Cardiology, P.C.
Birmingham, Alabama, United States
Scripps Clinic - Torrey Pines, Scripps Green Hospital
La Jolla, California, United States
University of Florida
Gainesville, Florida, United States
Florida Hospital-Pepin Heart Institute
Tampa, Florida, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Duke University Hospital
Durham, North Carolina, United States
Texas Heart Institute
Houston, Texas, United States
University of Utah Health Care
Salt Lake City, Utah, 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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The ATHENA Trial
Identifier Type: -
Identifier Source: org_study_id