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The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of adult stem cells in patients with refractory chronic myocardial ischemia.
Condition or disease
Device: stem cell injection
This is a double-blind, prospective, randomized, placebo-controlled trial to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of adult autologous CD34+ cells mobilized with granulocyte colony stimulating factor for the reduction of angina episodes in patients with refractory chronic myocardial ischemia.
A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto--CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia (ACT34-CMI)
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
21 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
21-80 years of age
CCS functional class III or IV chronic refractory angina
unsuitable for conventional revascularization
predominant congestive heart failure
left ventricular ejection fraction of less than 25% at screening
myocardial infarction within 60 days of treatment
successful coronary revascularization within 6 months of study enrollment
history of moderate to severe aortic stenosis or prosthetic aortic valve
co-morbidity associated with life expectancy of less than 1 year