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Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)


Randomized, Controlled, Phase II, Double-Blind Trial of Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Patients With Chronic Ischemic Heart Disease and Left Ventricular Dysfunction




Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today`s standard treatments. One new treatment approach uses stem cells—specialized cells capable of developing into other types of cells—to stimulate growth of new blood vessels for the heart. This study will determine the safety and effectiveness of withdrawing stem cells from someone`s bone marrow and injecting those cells into the person`s heart as a way of treating people with CAD and heart failure.

Study Status: Completed


Condition Intervention Phase
Chronic Ischemic Heart Disease
Left Ventricular Dysfunction
Ischemic Cardiomyopathy
Biological: Adult stem cells
Biological: Placebo
Phase 2

Verified by The University of Texas Health Science Center, Houston April, 2013

Sponsored by: The University of Texas Health Science Center, Houston
Information provided by: The University of Texas Health Science Center, Houston identifier: NCT00824005

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Robert Simari, MD., Study Chair

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