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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 . CLINICAL TRIAL REGISTRATION URL : www.controlled-trials.com . Unique identifier : ISRCTN63336619 .
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Intervention_Pharmacological
Granulocyte-colony stimulating factor
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Intervention_Physical
stem cell
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Intervention_Pharmacological
Granulocyte-colony stimulating factor ( G-CSF )
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Intervention_Pharmacological
G-CSF
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Participant_Sample-size
60
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Participant_Condition
ischemic or hemorrhagic stroke
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Participant_Sample-size
Sixty
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Participant_Age
mean age 71 years ( ± 12 years
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Participant_Sex
men