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    Clinical Trial Results:
    A phase I/II safety and tolerability dose escalation study following the autologous infusion of expanded adult haemopoietic stem cells to patients with liver insufficiency

    Summary
    EudraCT number
    		 2005-001222-83
    Trial protocol
    		 GB  
    Global end of trial date
    30 Apr 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Oct 2019
    First version publication date
    24 Oct 2019
    Other versions
    Summary report(s)
    		 End of Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    HHSC/001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00655707
    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
    Professor Nagy Habib, Imperial College London, +44 2033138574 , nagy.habib@imperial.ac.uk
    Scientific contact
    Professor Nagy Habib, Imperial College London, +44 2033138574 , nagy.habib@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
    21 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the maximum tolerated dose of expanded autologous cells derived from a subset of CD34+ stem cells when infused into either the hepatic artery or the portal vein. The trial will also seek to determine clinical improvement or deterioration by measurement of clinical parameters such as liver function tests.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2006
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient were recruited between 2006 and 2009 at Hammersmith Hospital

    Pre-assignment
    Screening details
    		 The study was based on the hypothesis that the CD34+ cell population in granulocyte colony-stimulating factor (G-CSF)-mobilised blood contains a subpopulation of cells with the potential for regenerating damaged tissue. 5 participants were recruited.

    Period 1
    Period 1 title
    Autologous CD34+ cells (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Autologous CD34+ cells
    Arm description
    		 Patients with chronic liver failure who fitted the study inclusion/exclusion criteria were admitted to the ward and were given 520 μg granulocyte-colony stimulating factor by subcutaneous injection for five consecutive days to increase the number of circulating CD34+ cells. Leukapheresis was performed on Day 5. The leukapheresis product was transferred to the GCP laboratory where CD34+ cells were immunoselected using the CliniMacs device (Miltenyi Biotech). The CD34+ cells were then transferred to the patient via the hepatic artery (2 patients) or portal vein (3 patients) in the Imaging Department.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous CD34+ cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Other use
    Dosage and administration details
    Patients with chronic liver failure who fitted the study inclusion/exclusion criteria were admitted to the ward and were given 520 μg granulocyte-colony stimulating factor by subcutaneous injection for five consecutive days to increase the number of circulating CD34+ cells. Leukapheresis was performed on Day 5. The leukapheresis product was transferred to the GCP laboratory where CD34+ cells were immunoselected using the CliniMacs device (Miltenyi Biotech). The CD34+ cells were then transferred to the patient via the hepatic artery (2 patients) or portal vein (3 patients) in the Imaging Department. 1 x 10^6 (3 patients) and 2 x 10^8 cells (2 patients)

    Number of subjects in period 1
    		Autologous CD34+ cells
    Started
    5
    Completed
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Autologous CD34+ cells
    Reporting group description
    		 -

    Reporting group values
    		 Autologous CD34+ cells Total
    Number of subjects
    		 5 5
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
    Age continuous
    Units: years
        geometric mean (full range (min-max))
    		 49.4 (42 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Autologous CD34+ cells
    Reporting group description
    		 Patients with chronic liver failure who fitted the study inclusion/exclusion criteria were admitted to the ward and were given 520 μg granulocyte-colony stimulating factor by subcutaneous injection for five consecutive days to increase the number of circulating CD34+ cells. Leukapheresis was performed on Day 5. The leukapheresis product was transferred to the GCP laboratory where CD34+ cells were immunoselected using the CliniMacs device (Miltenyi Biotech). The CD34+ cells were then transferred to the patient via the hepatic artery (2 patients) or portal vein (3 patients) in the Imaging Department.

    Primary: Number of Patients Who Tolerated the Maximum Dose

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    End point title
    		 Number of Patients Who Tolerated the Maximum Dose [1]
    End point description
    Tolerated 1 x 10^6 or 2 x 10^8 cells
    End point type
    Primary
    End point timeframe
    12 months
    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: Low number of participants for statistical analyses
    End point values
    		 Autologous CD34+ cells
    Number of subjects analysed
    5
    Units: Participants
    5
    No statistical analyses for this end point

    Primary: Number of participants without specific treatment related side effect

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    End point title
    		 Number of participants without specific treatment related side effect [2]
    End point description
    To assess the safety of ascending doses of autologous adult stem cells when introduced into either the hepatic artery or the portal vein and to determine the maximum tolerated dose of stem cells.
    End point type
    Primary
    End point timeframe
    12 months
    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: Low number of participants for statistical analyses
    End point values
    		 Autologous CD34+ cells
    Number of subjects analysed
    5
    Units: Participants
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    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
    Renal and urinary disorders
    Urinary tract infection
         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
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    Surgical and medical procedures
    Pain
         subjects affected / exposed
    4 / 5 (80.00%)
         occurrences all number
    4
    Immune system disorders
    Fever
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    4 / 5 (80.00%)
         occurrences all number
    4
    Ascites
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    3

    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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