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    Clinical Trial Results:
    MAcrophage Therapy for Liver Cirrhosis (MATCH)

    Summary
    EudraCT number
    		 2015-000963-15
    Trial protocol
    		 GB  
    Global end of trial date
    24 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2025
    First version publication date
    30 May 2025
    Other versions
    Summary report(s)
    		 Autologous macrophage therapy for liver cirrhosis: a phase 2 open-label randomized controlled trial

    Trial information

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    Trial identification
    Sponsor protocol code
    MATCH0.1
    Additional study identifiers
    ISRCTN number
    		 ISRCTN10368050
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Edinburgh/NHS Lothian:ACCORD
    Sponsor organisation address
    QMRI, 47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Professor Stuart Forbes, University of Edinburgh, +44 0131 651 9500, stuart.forbes@ed.ac.uk
    Scientific contact
    Professor Stuart Forbes, University of Edinburgh, +44 0131 651 9500, stuart.forbes@ed.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
    08 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I (dose escalation study): The primary objective of this study is to demonstrate safety and the maximum tolerated dose of autologous monocyte derived macrophages in participants with advanced liver cirrhosis. Phase II (randomised control trial): The primary objective of the randomised control trial is to demonstrate an improvement in the severity of liver disease over 3 months.
    Protection of trial subjects
    The Phase I dose escalation arm was a 3+3 design, progressing to higher dose after safety review of the IDMC. The dose used in the RCT was limited to the maximum achieved dose of 1x10^9, the highest dose tested in the dose escalation phase. To minimise discomfort and reduce the potential for a transfusion reaction during cell infusion 10mg IV Chlorphenamine and 100mg IV Hydrocortisone was administered before pre-hydration with 250mls normal saline. During the SARS CoV2 pandemic additional safety measures were in place to protect participants during study visits.
    Background therapy
    		 Other than standard care, no background therapy was used.
    Evidence for comparator
    		 No comparator was used In the dose escalation phase, in the RCT phase the cell product was compared to standard care as no comparative treatment is available for this patient group.
    Actual start date of recruitment
    08 Aug 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    0
    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)
    9
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment opened on the dose escalation phase on 03/08/2016, the last patient in the Phase I dose escalation arm was enrolled 23/03/2017. Recruitment on the RCT arm opened 13/09/2017 recruitment was closed 22/11/2021, once the minimum target of 23 participants in each randomised group had achieved the 3 month primary end point threshold.

    Pre-assignment
    Screening details
    		 The study was conducted in two different phases. After determining the recommended Phase II RCT dose, in the Phase I dose escalation part. Subjects were enrolled in Phase II RCT to estimate the safety and efficacy of autologous monocyte derived macrophages in participants with advanced liver cirrhosis.

    Pre-assignment period milestones
    Number of subjects started
    		 11
    Intermediate milestone: Number of subjects
    Dose escalation screening: 11
    Number of subjects completed
    		 9

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Failed screening: 2
    Period 1
    Period 1 title
    Phase I Dose Escalation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase I Dose Escalation 10^7
    Arm description
    		 Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose of up to 10^7
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cell infusion dose 10^7
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose 10^7

    Arm title
    		 Phase I Dose Escalation 10^8
    Arm description
    		 Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose of up to 10^8
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cell infusion dose 10^8
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose 10^8

    Arm title
    		 Phase I Dose Escalation 10^9
    Arm description
    		 Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose of up to 10^9
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cell infusion dose 10^9
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose 10^9

    Number of subjects in period 1 [1]
    		Phase I Dose Escalation 10^7 Phase I Dose Escalation 10^8 Phase I Dose Escalation 10^9
    Started
    3
    3
    3
    Completed
    3
    3
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Discrepancies due to participants failing screening

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase I Dose Escalation
    Reporting group description
    		 -

    Reporting group values
    		 Phase I Dose Escalation Total
    Number of subjects
    		 9 9
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Age at recruitment
    Units: years
        arithmetic mean (standard deviation)
    		 57.6 ( 5.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 5 5
    Dominant aetiology of liver disease
    Investigators were directed to indicate the dominant aetiology of liver disease
    Units: Subjects
        Alcoholic liver diease
    		 6 6
        primary biliary cirrhosis
    		 1 1
        non-alcoholic fatty liver disease
    		 1 1
        Previous Hepatitis C
    		 1 1
        cryptogenic cirrhosis
    		 0
        Haemochromotosis
    		 0
    Subject analysis sets

    Subject analysis set title
    Dose Escalation
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All recruited participants in the dose escalation phase

    Subject analysis set title
    Dose Escalation1x10^7
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants in the dose escalation phase allocated to receive 1x10^7

    Subject analysis set title
    Dose Escalation 1x10^8
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants in the dose escalation phase allocated to receive 1x10^8

    Subject analysis set title
    Dose Escalation 1x10^9
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants in the dose escalation phase allocated to receive 1x10^9

    Subject analysis sets values
    		 Dose Escalation Dose Escalation1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Number of subjects
    11
    3
    3
    3
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    9
    2
    3
    3
        From 65-84 years
    2
    1
        85 years and over
    0
    Age continuous
    Age at recruitment
    Units: years
        arithmetic mean (standard deviation)
    58.55 ( 5.85 )
    59.3 ( 8.5 )
    55.7 ( 6.4 )
    57.7 ( 2.9 )
    Gender categorical
    Units: Subjects
        Female
    4
    2
    0
    2
        Male
    7
    1
    3
    1
    Dominant aetiology of liver disease
    Investigators were directed to indicate the dominant aetiology of liver disease
    Units: Subjects
        Alcoholic liver diease
    7
    2
    2
    2
        primary biliary cirrhosis
    1
    1
        non-alcoholic fatty liver disease
    2
    1
        Previous Hepatitis C
    1
    1
        cryptogenic cirrhosis
    0
        Haemochromotosis
    0

    End points

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    End points reporting groups
    Reporting group title
    Phase I Dose Escalation 10^7
    Reporting group description
    		 Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose of up to 10^7

    Reporting group title
    Phase I Dose Escalation 10^8
    Reporting group description
    		 Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose of up to 10^8

    Reporting group title
    Phase I Dose Escalation 10^9
    Reporting group description
    		 Given cell infusion of the autologous monocyte derived macrophage product up to a maximum dose of up to 10^9

    Subject analysis set title
    Dose Escalation
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All recruited participants in the dose escalation phase

    Subject analysis set title
    Dose Escalation1x10^7
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants in the dose escalation phase allocated to receive 1x10^7

    Subject analysis set title
    Dose Escalation 1x10^8
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants in the dose escalation phase allocated to receive 1x10^8

    Subject analysis set title
    Dose Escalation 1x10^9
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants in the dose escalation phase allocated to receive 1x10^9

    Primary: Macrophage Activation Syndrome

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    End point title
    		 Macrophage Activation Syndrome [1]
    End point description
    Macrophage Activation Syndrome occurring during the infusion visit
    End point type
    Primary
    End point timeframe
    During infusion visit
    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 comparative analysis performed, percentage of participants with the primary end point presented
    End point values
    		 Dose Escalation1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Number of subjects analysed
    3
    3
    3
    Units: Participants
        Present
    0
    0
    0
        Absent
    3
    3
    3
    No statistical analyses for this end point

    Primary: Dose limiting toxicity

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    End point title
    		 Dose limiting toxicity [2]
    End point description
    Presence of a dose limiting toxicity (as defined in study protocol) from infusion to 14 post-infusion
    End point type
    Primary
    End point timeframe
    From infusion to 14 days post infusion
    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 comparative analysis performed, percentage of participants with the primary end point presented
    End point values
    		 Dose Escalation1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Number of subjects analysed
    3
    3
    3
    Units: Participants
        Presence
    0
    0
    0
        Absence
    3
    3
    3
    No statistical analyses for this end point

    Primary: Acute transfusion reaction

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    End point title
    		 Acute transfusion reaction [3]
    End point description
    Presence of acute transfusion reactions during the period of infusion
    End point type
    Primary
    End point timeframe
    During infusion
    Notes
    [3] - 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 comparative analysis performed, percentage of participants with the primary end point presented
    End point values
    		 Dose Escalation1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Number of subjects analysed
    3
    3
    3
    Units: Participants
        Present - clinically significant
    0
    0
    0
        Present - not clinically significant
    1
    0
    0
        Absent
    2
    3
    3
    No statistical analyses for this end point

    Primary: Acute transfusion reaction post infusion

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    End point title
    		 Acute transfusion reaction post infusion [4]
    End point description
    Presence of acute transfusion reaction 0 to 2 hours post infusion
    End point type
    Primary
    End point timeframe
    0 to 2 hours post infusion
    Notes
    [4] - 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 comparative analysis performed, percentage of participants with the primary end point presented
    End point values
    		 Dose Escalation1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Number of subjects analysed
    3
    3
    3
    Units: Participant
        Present - clinically significant
    0
    0
    0
        Present - not clinically significant
    1
    0
    0
        Absent
    2
    3
    3
    No statistical analyses for this end point

    Secondary: Change in MELD

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    End point title
    		 Change in MELD
    End point description
    Change in MELD score at 90 days from baseline
    End point type
    Secondary
    End point timeframe
    Baseline to 90 day change in MELD score
    End point values
    		 Dose Escalation
    Number of subjects analysed
    9 [5]
    Units: score
        arithmetic mean (standard deviation)
    -1.12 ( 1.87 )
    Notes
    [5] - Figures only available for participants who received infusion
    No statistical analyses for this end point

    Secondary: Change in serum albumin

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    End point title
    		 Change in serum albumin
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 90 day change
    End point values
    		 Dose Escalation
    Number of subjects analysed
    9
    Units: g dl-1
        arithmetic mean (standard deviation)
    -0.20 ( 0.23 )
    No statistical analyses for this end point

    Secondary: Change in UKELD

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    End point title
    		 Change in UKELD
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 90 day change
    End point values
    		 Dose Escalation
    Number of subjects analysed
    9
    Units: score
        arithmetic mean (standard deviation)
    -0.42 ( 2.27 )
    No statistical analyses for this end point

    Secondary: Change in INR

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    End point title
    		 Change in INR
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 90 day change
    End point values
    		 Dose Escalation
    Number of subjects analysed
    9
    Units: ratio
        arithmetic mean (standard deviation)
    -0.04 ( 0.09 )
    No statistical analyses for this end point

    Secondary: Change in ELF

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    End point title
    		 Change in ELF
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 90 day change
    End point values
    		 Dose Escalation
    Number of subjects analysed
    Units: score
        arithmetic mean (standard deviation)
    -0.24 ( 0.46 )
    No statistical analyses for this end point

    Secondary: Change in PRO-C3M

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    End point title
    		 Change in PRO-C3M
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 90 day change
    End point values
    		 Dose Escalation
    Number of subjects analysed
    Units: score
        arithmetic mean (standard deviation)
    -14.86 ( 14.50 )
    No statistical analyses for this end point

    Secondary: Change in C3M

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    End point title
    		 Change in C3M
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 90 day change
    End point values
    		 Dose Escalation
    Number of subjects analysed
    Units: score
        arithmetic mean (standard deviation)
    -10.95 ( 13.37 )
    No statistical analyses for this end point

    Secondary: Transplant free survival

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    End point title
    		 Transplant free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to one year follow-up
    End point values
    		 Dose Escalation1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Number of subjects analysed
    3
    3
    3
    Units: participants
        Alive, transplant free
    3
    3
    3
        Dead or transplanted
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    consent to 12 month follow up
    Adverse event reporting additional description
    participants were asked to report adverse events that may have occurred since the previous visit, at every visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Dose Escalation 1x10^7
    Reporting group description
    		 Cell infusion at maximum dose of up to 1x10^7

    Reporting group title
    Dose Escalation 1x10^8
    Reporting group description
    		 Cell infusion at maximum dose of up to 1x10^8

    Reporting group title
    Dose Escalation 1x10^9
    Reporting group description
    		 Cell infusion at maximum dose of up to 1x10^9

    Serious adverse events
    		 Dose Escalation 1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary lesion
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea and vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Dose Escalation 1x10^7 Dose Escalation 1x10^8 Dose Escalation 1x10^9
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    General disorders and administration site conditions
    Fatigue
    Additional description: including increase in lethargy
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
         occurrences all number
    1
    1
    3
    Malaise
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Right side pressure
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Sweats
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    1
    Reproductive system and breast disorders
    Vaginal prolapse
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Coryzal illness
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
         occurrences all number
    2
    1
    1
    Shortness of breath, chest pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Abrasion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Lesion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    2
    Toe injury
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Laceration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    lightheaded
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    2
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: This includes, discomfort, cramp or pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Ademonas Colon
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Ascites
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Varices oesophageal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Endocrine disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
         occurrences all number
    1
    2
    2
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
         occurrences all number
    4
    8
    4
    Tightness of jaw
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2016
    Inclusion criteria changed to include new government guidelines for alcohol intake (14 units per week) for both males and females) Previously government guidance included 21 units per week for men and 14 units for females.
    23 May 2017
    Hepatitis E virus testing added to the inclusion criteria Changes to the manufacturing process, following evidence that a single change was sufficient for cell growth, the protocol was modified to a one change of media rather than two.
    12 Aug 2017
    Blood tests change to include magnesium in baseline investigations
    20 Nov 2017
    Addition of the Protein fingerprint Biomarker test to the blood samples from the Dose Escalation Phase Clarification that for the RCT phase participants are required to fast for up to 4 hours prior to visit Clarification that for clinical visits MELD score is determined by the study team using the online calculator adopted by the Scottish Liver Transplant unit.
    13 Feb 2018
    Screening for eligibility was modified to allow time for clinical investigations where required, to be concluded prior to determining eligibility. Where possible all information was collected at the same visit however for some participants additional information was required, in such circumstances screening could be conducted up to 30days pre apheresis and the randomisation visit to be conducted 7 days pre apheresis. All patients will have paired MRI scans
    18 Jul 2018
    Treatment schedule changed from 3 infusions to 1 for participants allocated to the cell group, consequently the apheresis, infusion and safety visits for infusions two and three were removed from the protocol resulting in the number of visits for treatment group being reduced from 17 to 11 The upper bound for the inclusion criteria of MELD was changed from a maximum of 16 to requiring a maximum of 17.
    05 Nov 2018
    Change from a single to multicentre study. With the addition of two study sites in Scotland, both of which are situated in large University Hospitals. Participants were recruited from all three study sites, however apheresis and infusion visits were conducted at the lead study site. Due to logistical requirements only participants recruited at the lead site underwent MRI investigations.
    21 May 2020
    Addition of SARS-CoV-2 testing for all participants at screening visit and apheresis visit for participants allocated to the treatment group. Additional manufacturing site at Jack Copland Centre, Scottish National Blood Transfusion Service HQ.
    31 Mar 2021
    Updates to the Protocol and PIS to ensure 7 days between any vaccination for COVID-19 and apheresis, to reflect the guidance from the United Kingdom Blood Transfusion & Tissue Transplantation Services and the Joint Professional Advisory Committee (JPAC).
    10 Aug 2021
    Change in IMP shelf life from 48 to 24hrs based on new Scottish Blood Transfusion stability data, it should be noted that all Autologous Macrophage Cell Products released on the MATCH01 trial were administered within the 24hours.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Mar 2017
    Recruitment in the Phase I dose escalation arm was completed 23/03/2017, recruitment was then paused to allow the pre planned analysis of the data collected. The randomised control trial opened 13/09/2017 after the IDMC had reviewed the dose escalation data report and agreed progression to the RCT arm of the study.
    13 Sep 2017
    20 Mar 2020
    During the SARS-CoV-2 pandemic all study recruitment was halted for a period of four months, however all follow-up visits continued uninterrupted. No participants dropped out of the study or were lost to follow-up during this period.
    31 Jul 2020

    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/31591593
    http://www.ncbi.nlm.nih.gov/pubmed/34750149
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