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    Clinical Trial Results:
    A phase I safety and tolerability study of infusing the autologous progeny of an adult CD34+ subset into patients with type I diabetes mellitus and a successful renal transplant.

    Summary
    EudraCT number
    		 2006-002328-40
    Trial protocol
    		 GB  
    Global end of trial date
    31 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2019
    First version publication date
    13 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HHSC/005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00788827
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensingston Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Charles Pusey, Imperial College London, +44 20 8383 2308, c.pusey@imperial.ac.uk
    Scientific contact
    Charles Pusey, Imperial College London, +44 20 8383 2308, c.pusey@imperial.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
    30 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerance of a high dose of autologous expanded progeny of adult CD34+ stem cell subset (InsulinCytes) when introduced into either the body or tail of the pancreas.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 2008
    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: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at Imperial College NHS Healthcare Trust, Hammersmith Hospital between November 2008 and May 2013

    Pre-assignment
    Screening details
    		 A total of seven participants were eligible for the study

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Autologous CD34+ Stem Cells
    Arm description
    		 Patients received Autologous CD34+ Stem Cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    CD34+ Stem Cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    The expanded autologous CD34+ cells were infused into the right hepatic artery of the patients in the imaging department.

    Number of subjects in period 1
    		Autologous CD34+ Stem Cells
    Started
    7
    Completed
    5
    Not completed
    2
         Lack of efficacy
    2

    Baseline characteristics

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

    Reporting group values
    		 Overall Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 7
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 54.6 ( 4.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Pre Infusion of Stem Cells
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Mean HbA1c laboratory measurements pre stem cell infusion

    Subject analysis set title
    Post Infusion of Stem Cells
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Mean HbA1c laboratory measurements post stem cell infusion

    Subject analysis sets values
    		 Pre Infusion of Stem Cells Post Infusion of Stem Cells
    Number of subjects
    5
    5
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    5
    5
    Age continuous
    Units: years
        geometric mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Autologous CD34+ Stem Cells
    Reporting group description
    		 Patients received Autologous CD34+ Stem Cells

    Subject analysis set title
    Pre Infusion of Stem Cells
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Mean HbA1c laboratory measurements pre stem cell infusion

    Subject analysis set title
    Post Infusion of Stem Cells
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Mean HbA1c laboratory measurements post stem cell infusion

    Primary: Number of Participants Who Experienced Adverse Events_Haematoma at femoral catheter insertion

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    End point title
    		 Number of Participants Who Experienced Adverse Events_Haematoma at femoral catheter insertion [1]
    End point description
    End point type
    Primary
    End point timeframe
    14 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 statistical analyses due to low number of participants.
    End point values
    		 Autologous CD34+ Stem Cells
    Number of subjects analysed
    7
    Units: Participants
    1
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced Adverse Events_Fatigue

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    End point title
    		 Number of Participants Who Experienced Adverse Events_Fatigue [2]
    End point description
    End point type
    Primary
    End point timeframe
    14 days
    Notes
    [2] - 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 statistical analyses due to low number of participants.
    End point values
    		 Autologous CD34+ Stem Cells
    Number of subjects analysed
    7
    Units: Participants
    7
    No statistical analyses for this end point

    Secondary: Hba1C Data of Pre and Post Stem Cell Infusion

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    End point title
    		 Hba1C Data of Pre and Post Stem Cell Infusion
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Pre Infusion of Stem Cells Post Infusion of Stem Cells
    Number of subjects analysed
    5
    5
    Units: percentage
        geometric mean (standard deviation)
    7.2 ( 1.3 )
    7.24 ( 1.2 )
    Statistical analysis title
    		 Hba1C Data of Pre and Post Stem Cell Infusion
    Comparison groups
    Pre Infusion of Stem Cells v Post Infusion of Stem Cells
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Insulin level

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    End point title
    		 Insulin level
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Pre Infusion of Stem Cells Post Infusion of Stem Cells
    Number of subjects analysed
    5
    5
    Units: iu/day
        geometric mean (standard deviation)
    59.4 ( 25.7 )
    54.06 ( 18.2 )
    No statistical analyses for this end point

    Secondary: Amylase Level

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    End point title
    		 Amylase Level
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Pre Infusion of Stem Cells Post Infusion of Stem Cells
    Number of subjects analysed
    5
    5
    Units: units/L
        geometric mean (standard deviation)
    48.49 ( 25.2 )
    75.52 ( 34.2 )
    No statistical analyses for this end point

    Secondary: Serum Creatinine

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    End point title
    		 Serum Creatinine
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Pre Infusion of Stem Cells Post Infusion of Stem Cells
    Number of subjects analysed
    5
    5
    Units: umol/L
        geometric mean (standard deviation)
    128.22 ( 11.9 )
    118.64 ( 15.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Autologous CD34+ Stem Cells
    Reporting group description
    		 Patients received Autologous CD34+ Stem Cells

    Serious adverse events
    		 Autologous CD34+ Stem Cells
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Autologous CD34+ Stem Cells
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    Nervous system disorders
    Fatigue
         subjects affected / exposed
    7 / 7 (100.00%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Haemotoma
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    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
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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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