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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
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.
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.
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
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: 1. Treatment emergent SAEs 2. Arrhythmia assessment via Holter monitoring 3. MACE defined as cardiac death and hospitalization for heart failure Feasibility endpoints include: 1. Change in mVO2 at 6 months 2. Change in LVESV/LVEDV at 6 months 3. Change in ejection fraction at 6 months 4. Change in perfusion defect at 6 months 5. Resource utilization 6. Change in heart failure symptoms, angina, and quality of life through 12 months
Time frame: 6 and 12 Months
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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