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Granulocyte Colony Stimulating Factor and Physiotherapy after Stroke: Results of a Feasibility Randomised Controlled Trial: Stem Cell Trial of Recovery EnhanceMent after Stroke-3 (STEMS-3 ISRCTN16714730)

Sprigg, Nikola; O’Connor, Rebecca; Woodhouse, Lisa J.; Krishnan, Kailash; England, Timothy J.; Connell, Louise Anne; Walker, Marion F.; Bath, Philip M.W.

Authors

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

Rebecca O’Connor

Kailash Krishnan

Louise Anne Connell

Marion F. Walker

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine



Abstract

Background
Granulocyte-colony stimulating factor (G-CSF) mobilises endogenous haematopoietic stem cells and enhances recovery in experimental stroke. Recovery may also be dependent on an enriched environment and physical activity. G-CSF may have the potential to enhance recovery when used in combination with physiotherapy, in patients with disability late after stroke.
Methods
A pilot 2 x 2 factorial randomised (1:1) placebo-controlled trial of G-CSF (double-blind), and/ or a 6 week course of physiotherapy, in 60 participants with disability (mRS >1), at least 3 months after stroke. Primary outcome was feasibility, acceptability and tolerability. Secondary outcomes included death, dependency, motor function and quality of life measured 90 and 365 days after enrolment.
Results
Recruitment to the trial was feasible and acceptable; of 118 screened patients, 92 were eligible and 32 declined to participate. 60 patients were recruited between November 2011 and July 2013. All participants received some allocated treatment. Although 29 out of 30 participants received all 5 G-CSF/placebo injections, only 7 of 30 participants received all 18 therapy sessions. G-CSF was well tolerated but associated with a tendency to more adverse events than placebo (16 vs 10 patients, p = 0.12) and serious adverse events (SAE) (9 vs 3, p = 0.10). On average, patients received 14 (out of 18 planned) therapy sessions, interquartile range [12, 17]. Only a minority (23%) of participants completed all physiotherapy sessions, a large proportion of sessions (114 of 540, 21%) were cancelled due to patient (94, 17%) and therapist factors (20, 4%). No significant differences in functional outcomes were detected in either the G-CSF or physiotherapy group at day 90 or 365.
Conclusions
Delivery of G-CSF is feasible in chronic stroke. However, the study failed to demonstrate feasibility for delivering additional physiotherapy sessions late after stroke therefore a definitive study using this trial design is not supported. Future work should occur earlier after stroke, alongside on-going clinical rehabilitation.

Citation

Sprigg, N., O’Connor, R., Woodhouse, L. J., Krishnan, K., England, T. J., Connell, L. A., …Bath, P. M. (2016). Granulocyte Colony Stimulating Factor and Physiotherapy after Stroke: Results of a Feasibility Randomised Controlled Trial: Stem Cell Trial of Recovery EnhanceMent after Stroke-3 (STEMS-3 ISRCTN16714730). PLoS ONE, 11(9), https://doi.org/10.1371/journal.pone.0161359

Journal Article Type Article
Acceptance Date Aug 4, 2016
Online Publication Date Sep 9, 2016
Publication Date Sep 9, 2016
Deposit Date Oct 28, 2016
Publicly Available Date Oct 28, 2016
Journal PLoS ONE
Electronic ISSN 1932-6203
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 11
Issue 9
Article Number e0161359
DOI https://doi.org/10.1371/journal.pone.0161359
Public URL http://eprints.nottingham.ac.uk/id/eprint/38028
Publisher URL http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0161359
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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