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 7 (35%) of 20, death or dependency (modified Rankin Score: G-CSF 3.3±1.3, placebo 3.0±1.3) at 90 days, or the number of injections received. G-CSF increased CD34+ 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 (P=0.06). In 1 participant, there was suggestion that labeled CD34+ cells had migrated to the ischemic lesion.
Conclusions—This randomized, double-blind, placebo-controlled trial suggests that G-CSF is safe when administered subacutely. It is feasible to label and readminister iron-labeled CD34+ cells in patients with ischemic stroke.
- Received August 19, 2011.
- Revision received August 19, 2011.
- Accepted September 16, 2011.
- © 2011 American Heart Association, Inc.