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Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina


A Prospective, Randomized, Double-blinded, Active-control and Unblinded Standard of Care (SOC) Controlled Study to Determine the Efficacy and Safety of Targeted Intramyocardial Delivery of Autologous CD34+ Cells (Auto-CD34+ Cells) for Increasing Exercise Capacity During Standardized Exercise Testing in Subjects With Refractory Angina Pectoris and Chronic Myocardial Ischemia




The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.

Study Status: Recruiting


Condition Intervention Phase
Chronic Myocardial Ischemia
Refractory Angina Pectoris
(Advanced) Coronary Heart Disease
Biological: Auto-CD34+ cells
Biological: Placebo: Diluent used to suspend Auto-CD34+ cells
Other: Standard of care
Phase 3

Verified by Baxter Healthcare Corporation June, 2012

Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation identifier: NCT01508910

Study Type: Interventional

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

Cleveland Clinic Foundation, Cardiology Department
Cleveland, Ohio 44195
United States

Adel Nada, MD, MS., Study Director

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