Granulocyte-Colony Stimulating Factor for Mobilizing Bone Marrow Stem Cells in Subacute Stroke The Stem Cell Trial of Recovery Enhancement After Stroke 2 Randomized Controlled Trial

Background and Purpose—Granulocyte-colony stimulating factor (G-CSF) is neuroprotective in experimental stroke and mobilizes CD34+ 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 μg/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+ count, and functional outcome were measured. MRI assessed lesion volume, atrophy, and the presence of iron-labeled CD34+ cells reinjected on day 6. Results—Sixty patients were recruited at mean of 8 days (SD ±5) post ictus, with mean age 71 years (±12 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 ...