Background and Purpose-Granulocyte-colony stimulating factor (G-CSF) is neuroprotective in experimental stroke and mobilizes CD34 ϩ peripheral blood stem cells into the circulation. We assessed the safety of G-CSF in recent stroke in a phase IIb single-center randomized, controlled trial. Methods-G-CSF (10 g/kg) or placebo (ratio 2:1) was given SC for 5 days to 60 patients 3 to 30 days after ischemic or hemorrhagic stroke. The primary outcome was the frequency of serious adverse events. Peripheral blood counts, CD34 ϩ count, and functional outcome were measured. MRI assessed lesion volume, atrophy, and the presence of iron-labeled CD34 ϩ cells reinjected on day 6. Results-Sixty patients were recruited at mean of 8 days (SD Ϯ5) post ictus, with mean age 71 years (Ϯ12 years) and 53% men. The groups were well matched for baseline minimization/prognostic factors. There were no significant differences between groups in the number of participants with serious adverse events: G-CSF 15 (37.5%) of 40 versus placebo 7 (35%) of 20, death or dependency (modified Rankin Score: G-CSF 3.3Ϯ1.3, placebo 3.0Ϯ1.3) at 90 days, or the number of injections received. G-CSF increased CD34 ϩ and total white cell counts of 9.5-and 4.2-fold, respectively. There was a trend toward reduction in MRI ischemic lesion volume with respect to change from baseline in G-CSF-treated patients (Pϭ0.06). In 1 participant, there was suggestion that labeled CD34 ϩ cells had migrated to the ischemic lesion.
Conclusions-This