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    Clinical Trial Results:
    'Stem cell Trial of recovery EnhanceMent after Stroke 3’ (STEMS 3)- a pilot randomised controlled trial of G-CSF and therapy in chronic stroke

    Summary
    EudraCT number
    		 2011-001684-50
    Trial protocol
    		 GB  
    Global end of trial date
    30 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Feb 2019
    First version publication date
    24 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    11015
    Additional study identifiers
    ISRCTN number
    		 ISRCTN16714730
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Jubilee Campus, Triumph Road, Nottingham, United Kingdom, NG8 1DH
    Public contact
    Nikola Sprigg, University of Nottingham, +44 115 8231765, nikola.sprigg@nottingham.ac.uk
    Scientific contact
    Angela Shone, University of Nottingham, +44 115 8467906, angela.shone@nottingham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety, feasibility, and tolerability of delivering the drug G-CSF and or rehabilitation therapy in chronic stroke patients.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    26
    From 65 to 84 years
    32
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment commenced on 17th November 2011 and was completed on 1st July 2013

    Pre-assignment
    Screening details
    		 Participants had to demonstrate disability, mRs greater than 1 and no longer be receiving ongoing rehabilitation therapy. 3 months - 2 years post stroke

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 GCSF
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgastrim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x 10E6 iu/kg injection once per day for 5 days

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.9% solution once per day for 5 days

    Arm title
    		 Therapy
    Arm description
    		 -
    Arm type
    		 Received physiotherapy

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 No therapy
    Arm description
    		 -
    Arm type
    		 Standard care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		GCSF Placebo Therapy No therapy
    Started
    30
    30
    30
    30
    Completed
    30
    30
    30
    30
    Period 2
    Period 2 title
    Day 90
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GCSF
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgastrim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x 10E6 iu/kg injection once per day for 5 days

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.9% solution once per day for 5 days

    Arm title
    		 Therapy
    Arm description
    		 -
    Arm type
    		 Received physiotherapy

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 No therapy
    Arm description
    		 -
    Arm type
    		 Standard care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		GCSF Placebo Therapy No therapy
    Started
    30
    30
    30
    30
    Completed
    30
    27
    28
    29
    Not completed
    0
    3
    2
    1
         Lost to follow-up
    -
    3
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GCSF
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Therapy
    Reporting group description
    		 -

    Reporting group title
    No therapy
    Reporting group description
    		 -

    Reporting group values
    		 GCSF Placebo Therapy No therapy Total
    Number of subjects
    		 30 30 30 30 60
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 14 14 12 26
        From 65-84 years
    		 18 14 16 16 32
        85 years and over
    		 0 2 0 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.8 ( 8.33 ) 65.6 ( 12.8 ) 65.6 ( 9.46 ) 66.9 ( 11.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 11 11 13 24
        Male
    		 17 19 19 17 36

    End points

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    End points reporting groups
    Reporting group title
    GCSF
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Therapy
    Reporting group description
    		 -

    Reporting group title
    No therapy
    Reporting group description
    		 -
    Reporting group title
    GCSF
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Therapy
    Reporting group description
    		 -

    Reporting group title
    No therapy
    Reporting group description
    		 -

    Primary: Day 90 mRs

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    End point title
    		 Day 90 mRs
    End point description
    End point type
    Primary
    End point timeframe
    Day 90
    End point values
    		 GCSF Placebo Therapy No therapy
    Number of subjects analysed
    30
    27
    28
    29
    Units: Mean mRs
        arithmetic mean (standard deviation)
    2.8 ( 1.03 )
    2.9 ( 0.91 )
    2.9 ( 1.04 )
    2.8 ( 0.90 )
    Statistical analysis title
    		 GCSF comparison
    Comparison groups
    GCSF v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.46
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Therapy comparison
    Comparison groups
    No therapy v Therapy
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 90
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serious adverse events not recorded
    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 60 (20.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    SAE
         subjects affected / exposed
    12 / 60 (20.00%)
         occurrences causally related to treatment / all
    0 / 44
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    N/A

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27610616
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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