Coronary Artery Disease Clinical Trial
Official title:
A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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