Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRCs | Experimental | Adipose-Derived Regenerative Cells (ADRCs) processed by the Celution System:
|
|
| Placebo | Placebo Comparator | Placebo - Physiological Solution
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celution System | Device | ADRCs processed by the Celution System for reintroduction into the myocardium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire | Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment. | 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy - Change in mVO2 | Change in mVO2 at 6 months as assessed by Exercise Tolerance Test | 6 months post treatment |
| Secondary Efficacy - Change in LVESV/LVEDV | Change in LVESV/LVEDV at 6 months as assessed by Echocardiography |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Number of Patients Experiencing Treatment Emergent SAEs | Treatment through 12 months | |
| Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor | Screening through 3 months post treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emerson C. Perin, MD, PhD | The Stem Cell Center at Texas Heart Institute | Principal Investigator |
| Timothy Henry, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Case Medical Center | Cleveland | Ohio | 11100 | United States |
| 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. |
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Device | Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood |
|
| 6 months post treatment |
| Secondary Efficacy - Change in Ejection Fraction | Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography | 6 months post treatment |
| Secondary Efficacy - Change in perfusion defect | Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT | 6 months post treatment |
| Secondary Efficacy - Resource Utilization | Resource utilization - hospital length of stay, re-hospitalization for cardiac related events | through 12 months post treatment |
| Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life | Change in heart failure symptoms, angina, and quality of life assessed by - NYHA classification, CCS classification, MLHFQ (other than 6 months) | through 12 months post treatment |
| Safety - Number of patients that experience a MACE | Number of patients that experience a Major Adverse Cardiac Event (MACE) | Treatment through 12 months |
| D001157 |
| Arterial Occlusive Diseases |