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This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRCs processed by the Celution System | Experimental | 400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells. |
|
| Lactated Ringers and Subject's blood | Placebo Comparator | Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADRCs processed by the Celution System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization | Safety endpoints include:
Feasibility endpoints include:
| 6 and 12 Months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerson Perin, MD, PhD | Texas Heart Institute, Houston, TX | Principal Investigator |
| Timothy Henry, MD | Minneapolis Heart Institute Foundation, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, P.C. | Birmingham | Alabama | 35211 | United States | ||
| Scripps Clinic - Torrey Pines, Scripps Green Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27148802 | Result | 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. |
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|
|
| Placebo Comparator: Lactated Ringer's and Subject's Blood | Device | 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. |
|
|
| La Jolla |
| California |
| 92037 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Florida Hospital-Pepin Heart Institute | Tampa | Florida | 33613 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| University of Utah Health Care | Salt Lake City | Utah | 84132 | United States |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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