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Granulocyte-colony-stimulating factor mobilizes bone marrow stem cells in patients with subacute ischemic stroke: the Stem Cell Trial of Recovery EnhanceMent After Stroke (STEMS) Pilot Randomized, Controlled Trial (ISRCTN 16784092)

Sprigg, Nikola; Bath, Philip M.W.; Zhao, Lian; Willmot, Mark; Gray, Laura J.; Walker, Marion F.; Dennis, Martin S.; Russell, Nigel

Authors

Nikola Sprigg

Philip M.W. Bath

Lian Zhao

Mark Willmot

Laura J. Gray

Martin S. Dennis

Nigel Russell



Abstract

Background and Purpose - Loss of motor function is common after stroke and leads to significant chronic disability. Stem cells are capable of self-renewal and of differentiating into multiple cell types, including neurones, glia, and vascular cells. We assessed the safety of granulocyte-colony-stimulating factor (G-CSF) after stroke and its effect on circulating CD34 stem cells.

Methods - We performed a 2-center, dose-escalation, double-blind, randomized, placebo-controlled pilot trial (ISRCTN 16784092) of G-CSF (6 blocks of 1 to 10 g/kg SC, 1 or 5 daily doses) in 36 patients with recent ischemic stroke. Circulating CD34 stem cells were measured by flow cytometry; blood counts and measures of safety and functional outcome were also monitored. All measures were made blinded to treatment.

Results - Thirty-six patients, whose mean SD age was 768 years and of whom 50% were male, were recruited. G-CSF
(5 days of 10 g/kg) increased CD34 count in a dose-dependent manner, from 2.5 to 37.7 at day 5 (area under curve, P0.005). A dose-dependent rise in white cell count (P0.001) was also seen. There was no difference between
treatment groups in the number of patients with serious adverse events: G-CSF, 7/24 (29%) versus placebo 3/12 (25%),
or in their dependence (modified Rankin Scale, median 4, interquartile range, 3 to 5) at 90 days.

Conclusions - ”G-CSF is effective at mobilizing bone marrow CD34 stem cells in patients with recent ischemic stroke.
Administration is feasible and appears to be safe and well tolerated. The fate of mobilized cells and their effect on
functional outcome remain to be determined. (Stroke. 2006;37:2979-2983.)

Journal Article Type Article
Publication Date 2006-12
Journal Stroke
Print ISSN 0039-2499
Publisher American Heart Association
Peer Reviewed Peer Reviewed
Volume 37
Issue 12
Pages 2979-2983
APA6 Citation Sprigg, N., Bath, P. M., Zhao, L., Willmot, M., Gray, L. J., Walker, M. F., …Russell, N. (2006). Granulocyte-colony-stimulating factor mobilizes bone marrow stem cells in patients with subacute ischemic stroke: the Stem Cell Trial of Recovery EnhanceMent After Stroke (STEMS) Pilot Randomized, Controlled Trial (ISRCTN 16784092). Stroke, 37(12), 2979-2983. doi:10.1161/01.str.0000248763.49831.c3
DOI https://doi.org/10.1161/01.str.0000248763.49831.c3
Keywords ischemic stroke; stem cells; colony-stimulating factors; stroke recovery
Publisher URL https://www.ahajournals.org/doi/10.1161/01.STR.0000248763.49831.c3
Related Public URLs http://stroke.ahajournals.org/
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf
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