Granulocyte-Colony Stimulating Factor for Mobilizing Bone Marrow Stem Cells in Subacute Stroke
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- Timothy J. England
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
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- Maryam Abaei
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
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- Dorothee P. Auer
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
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- James Lowe
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
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- D. Rhodri E. Jones
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
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- Gillian Sare
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
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- Marion Walker
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
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- Philip M.W. Bath
- From the Stroke Trials Unit (T.J.E., G.S., P.M.W.B.), Radiological and Imaging Sciences (M.A., D.P.A.), Schools of Molecular Medical Sciences (J.L.) and Ageing and Disability (M.W.), University of Nottingham, Nottingham, United Kingdom; and Division of Pathology (D.R.E.J.), Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
書誌事項
- タイトル別名
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- The Stem Cell Trial of Recovery Enhancement After Stroke 2 Randomized Controlled Trial
説明
<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p> Granulocyte-colony stimulating factor (G-CSF) is neuroprotective in experimental stroke and mobilizes CD34 <jats:sup>+</jats:sup> 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. </jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p> 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 <jats:sup>+</jats:sup> count, and functional outcome were measured. MRI assessed lesion volume, atrophy, and the presence of iron-labeled CD34 <jats:sup>+</jats:sup> cells reinjected on day 6. </jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> 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 <jats:sup>+</jats:sup> 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 ( <jats:italic>P</jats:italic> =0.06). In 1 participant, there was suggestion that labeled CD34 <jats:sup>+</jats:sup> cells had migrated to the ischemic lesion. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p> 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 <jats:sup>+</jats:sup> cells in patients with ischemic stroke. </jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.controlled-trials.com">www.controlled-trials.com</jats:ext-link> . Unique identifier: ISRCTN63336619. </jats:p> </jats:sec>
収録刊行物
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- Stroke
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Stroke 43 (2), 405-411, 2012-02
Ovid Technologies (Wolters Kluwer Health)
