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ISRCTN
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ISRCTN16784092
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ClinicalTrials.gov identifier
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Public title
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A randomised placebo-controlled pilot trial of granulocyte-colony stimulating factor in mobilising bone marrow stem cells in sub-acute stroke: the 'Stem cell Trial of recovery EnhanceMent after Stroke' (STEMS) pilot study
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Scientific title
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Acronym
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STEMS
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Serial number at source
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Version 1.3 28/06/04
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Study hypothesis
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Loss of motor function is common after stroke and often leads to significant long-term disability. Stem cells can be mobilised into the circulation using granulocyte-colony stimulating factor (G-CSF), an approach that has been found to be effective in experimental stroke. We aim to perform a pilot randomised placebo-controlled dose-escalation trial of G-CSF (1 x 10^5 - 3 x 10^6 µ/kg given once or once daily for 5 days, in dosing blocks: 1 dose or 5 doses 1 x 10^5 µkg - 3 x 10^6 µ/kg, with level of 5 dose blocks depending on single dose data) in patients with motor weakness following ischaemic stroke, investigating its safety, feasibility of administration, tolerability, and effects on stem cell mobilisation, impairment, disability and dependency. The interaction between G-CSF and routine rehabilitation will be examined.
The study will last 24 months with 42 patients recruited over 19 months allowing 3 months follow-up. The results will help inform the design (inclusion criteria, outcomes, size) of further trials including the planning of a large definitive trial assessing the safety and efficacy (motor recovery and functional outcome) of G-CSF.
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Lay summary
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Ethics approval
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Ethics approval received from the Nottingham Local Research Committee on the 5th June 2003 and had Medicines and Healthcare Products Regulatory Agency Clinical Trial Authorisation on the 10th March 2003).
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Study design
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Randomised placebo controlled pilot trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke (ischaemic)
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Participants - inclusion criteria
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1. Clinical stroke (lacunar or cortical)
2. 7 - 30 days post-onset
3. Arm and/or leg weakness (Scandinavian Stroke Scale [SSS], arm and/or leg motor power less than 6)
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Participants - exclusion criteria
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1. Pre-morbid dependency, modified Rankin scale (mRS) greater than 3
2. Primary intracerebral haemorrhage
3. Dementia
4. Coma (SSS consciousness less than 4)
5. Malignancy
6. Sickle cell disease
7. Pregnancy
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Anticipated start date
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01/08/2003
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Anticipated end date
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01/08/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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42
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Interventions
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Subcutaneous human recombinant G-CSF (filgrastim from Amgen) versus placebo.
G-CSF - 1 x 10^5 - 3 x 10^6 µ/kg given once or once daily for 5 days, in dosing blocks: 1 dose or 5 doses 1 x 10^5 µ/kg - 3 x 10^6 µ/kg, with level of 5 dose blocks depending on single dose data.
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Primary outcome measure(s)
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1. Circulating CD 34+ (flow cytometry) stem cells - aim greater than 10 x 10^6/l
2. Clinical safety: death, recurrent stroke, deterioration, palpable splenomegaly, at 10 days
3. Laboratory safety: white cell count (WCC, differential), platelet count (PC)
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Secondary outcome measure(s)
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Clinical efficacy:
1. Impairment (SSS)
2. Disability (Barthel Index, [BI])
3. Dependency (mRS)
4. Cognition (Mini Mental State Examination [MMSE])
5. Depression (Zung)
6. Quality of life (EuroQOL)
7. Disposition (home, institution)
Outcomes measurd at 10 and 90 days.
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Sources of funding
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The Stroke Association (UK) (ref: TSA 01/03)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17082474
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Contact name
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Prof
Philip
Bath
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Address
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University of Nottingham
Clinical Sciences Building
Nottingham City Hospital Campus
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Sponsor
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University of Nottingham (UK)
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Address
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Clinical Sciences Building
Nottingham City Hospital Campus
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Sponsor website:
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http://www.nottingham.ac.uk
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Date applied
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26/08/2005
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Last edited
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20/12/2007
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Date ISRCTN assigned
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31/10/2005
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