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    Clinical Trial Results:
    A Phase I/II safety and tolerability study following autologous infusion of adult haematopoietic cells to patients with acute total anterior circulation ischaemic stroke

    Summary
    EudraCT number
    		 2006-000281-36
    Trial protocol
    		 GB  
    Global end of trial date
    03 Dec 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2020
    First version publication date
    08 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HHSC/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00535197
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Jeremy Chataway, Imperial College London, +44 020 7886 6666 , Jeremy.Chataway@imperial.nhs.uk
    Scientific contact
    Jeremy Chataway, Imperial College London, +44 020 7886 6666 , Jeremy.Chataway@imperial.nhs.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
    02 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety and tolerability of infused immuno-selected CD34+ autologous adult haematopoietic stem cells
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    3
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started December 2007 at Imperial College Healthcare National HealthServices Trust.

    Pre-assignment
    Screening details
    		 Due to the low recruitment/screen ratio, the criteria were expanded from August 2010 onward to include the partial anterior circulation stroke (PACS) subtype of ischemic stroke.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 CD34+ Stem/Progenitor Cell Therapy
    Arm description
    		 Participants received CD34+ Stem/Progenitor Cell Therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Immuno-selected CD34+ haematopoietic stem cells
    Investigational medicinal product code
    Other name
    Haematopoietic CD34+ stem cells
    Pharmaceutical forms
    Suspension for suspension for injection
    Routes of administration
    Intraarterial use
    Dosage and administration details
    CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery. Infusion of autologous CD34+ stem cells into middle cerebral artery: intra-arterial infusion into ipsilateral MCA, via trans-femoral approach. 1 x 10 to the 9 to cells/10mL

    Number of subjects in period 1
    		CD34+ Stem/Progenitor Cell Therapy
    Started
    5
    Completed
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 5 5
    Age categorical
    Units: Subjects
        Adults (Age 45-75)
    		 5 5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 58.2 (45 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    CD34+ Stem/Progenitor Cell Therapy
    Reporting group description
    		 Participants received CD34+ Stem/Progenitor Cell Therapy

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline measurements

    Primary: Number of a Serious Adverse Event Related to the Treatment

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    End point title
    		 Number of a Serious Adverse Event Related to the Treatment [1]
    End point description
    Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
    End point type
    Primary
    End point timeframe
    180 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistic is due to the nature of the primary outcome.
    End point values
    		 CD34+ Stem/Progenitor Cell Therapy
    Number of subjects analysed
    5
    Units: Number of participants
    0
    No statistical analyses for this end point

    Secondary: Changes in clinical function as assessed by the Modified Rankin Score

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    End point title
    		 Changes in clinical function as assessed by the Modified Rankin Score
    End point description
    The scales with possible scores ranging from 0 to 5. Zero is no symptoms at all, 5 is dead.
    End point type
    Secondary
    End point timeframe
    Day 0 (Baseline), day 180
    End point values
    		 CD34+ Stem/Progenitor Cell Therapy Baseline
    Number of subjects analysed
    5
    5
    Units: score
        arithmetic mean (full range (min-max))
    1.60 (0 to 3)
    3.80 (3 to 5)
    Statistical analysis title
    		 Modified Rankin Score
    Comparison groups
    CD34+ Stem/Progenitor Cell Therapy v Baseline
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Changes in Clinical Function as Assessed by the NIH Stroke Scale

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    End point title
    		 Changes in Clinical Function as Assessed by the NIH Stroke Scale
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0, Day 180
    End point values
    		 CD34+ Stem/Progenitor Cell Therapy Baseline
    Number of subjects analysed
    5
    5
    Units: score
        arithmetic mean (full range (min-max))
    2.20 (0 to 5)
    10.40 (4 to 17)
    Statistical analysis title
    		 NIH Stroke Scale
    Statistical analysis description
    Day 0 (baseline) compare to Day 180
    Comparison groups
    CD34+ Stem/Progenitor Cell Therapy v Baseline
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    180 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    CD34+ Stem/Progenitor Cell Therapy
    Reporting group description
    		 Participants received CD34+ Stem/Progenitor Cell Therapy

    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: No non-serious adverse event occurred.
    Serious adverse events
    		 CD34+ Stem/Progenitor Cell Therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal dysfunction
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 CD34+ Stem/Progenitor Cell Therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25107583
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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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