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
Philip M.W. Bath
Laura J. Gray
Professor MARION WALKER firstname.lastname@example.org
Professor of Stroke Rehabilitation
Martin S. Dennis
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|
|Publisher||American Heart Association|
|Peer Reviewed||Peer Reviewed|
|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|
|Keywords||ischemic stroke; stem cells; colony-stimulating factors; stroke recovery|
|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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