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
Rationale:
n/a
Purpose:
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
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Chronic Ischemic Heart Disease
Left Ventricular Dysfunction
Angina
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
ClinicalTrials.gov 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