The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived Stem \& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.
Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo. The outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Dose escalation
Rigshospitalet University Hospital
Copenhagen, Denmark
Erasmus University Medical Centrum, Thorax Center
Rotterdam, Netherlands
University of Utrecht Medical Center
Utrecht, Netherlands
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Time frame: Up to 36 months
Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography
Time frame: Up to 36 months
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