Background
Granulocyte colony-stimulating factor (G-CSF) has shown neuroprotective and neurogenerative
activities in experimental studies, and our previous phase I clinical study suggested
the safety and potential efficacy of low-dose G-CSF in acute ischemic stroke patients.
The present phase II trial is aimed to evaluate the effect of G-CSF administration
on neurological function and infarct volume, compared with a placebo group.
Methods
Forty-nine acute ischemic stroke patients (29 males, 20 females; 71 ± 10 years) within
24 hours after onset were recruited. Eligible patients were randomized 2:2:1 to receive
G-CSF 150 µg/body/day, G-CSF 300 µg/body/day, and placebo, respectively. We evaluated
clinical outcome in terms of the National Institutes of Health Stroke Scale, the modified
Rankin Scale, and the Barthel Index at 90 days after onset, together with changes
in infarct volume on magnetic resonance imaging.
Results
We found no serious adverse event, including change in leukocyte levels, which remained
below 31,000/µL, at 150 and 300 µg G-CSF/body/day. Clinical outcome scores did not
show any significant difference among the 3 groups. Chronological changes in infarct
volume also showed no significant difference.
Conclusions
G-CSF was well-tolerated at 150 and 300 µg/body/day in patients with acute ischemic
stroke. However, administration of G-CSF at both 150 and 300 µg/body/day neither contributed
to functional recovery nor reduced infarct volume at 3 months after onset, compared
with the control group. The apparent lack of effectiveness may have been due to the
small sample size. A trial of combination therapy with recombinant tissue plasminogen
activator and G-CSF is planned.
Key Words
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Article info
Publication history
Published online: March 23, 2016
Accepted:
January 11,
2016
Received in revised form:
January 5,
2016
Received:
December 28,
2015
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2016.01.022
Copyright
© 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.
