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Background— A growing population of patients with coronary artery disease experiences angina that is not amenable to revascularization and is refractory to medical therapy. Preclinical studies have indicated that human CD34⁺ stem cells induce neovascularization in ischemic myocardium, which enhances perfusion and function.

Methods and Results— Twenty-four patients (19 men and 5 women aged 48 to 84 years) with Canadian Cardiovascular Society class 3 or 4 angina who were undergoing optimal medical treatment and who were not candidates for mechanical revascularization were enrolled in a double-blind, randomized (3:1), placebo-controlled dose-escalating study. Patients received granulocyte colony-stimulating factor 5 μg · kg⁻¹ · d⁻¹ for 5 days with leukapheresis on the fifth day. Selection of CD34⁺ cells was performed with a Food and Drug Administration–approved device …