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    Clinical Trial Results:
    CD133 + CELL INFUSION IN PATIENTS WITH COLORECTAL LIVER ORIGIN METASTASES GOING TO BE SUBMITTED TO A MAJOR LIVER RESECTION

    Summary
    EudraCT number
    		 2014-001402-18
    Trial protocol
    		 ES  
    Global end of trial date
    31 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2022
    First version publication date
    16 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIR-MSC-2014-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alejandra García Botella
    Sponsor organisation address
    Profesor Martín Lagos s/n, Madrid, Spain, 28040
    Public contact
    UICEC, Fundación para la investigación biomédica del Hospital Clínico San Carlos, 0034 9133030003793, fibucicec.hcsc@salud.madrid.org
    Scientific contact
    UICEC, Fundación para la investigación biomédica del Hospital Clínico San Carlos, 0034 9133030003793, fibucicec.hcsc@salud.madrid.org
    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 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the effectiveness of preoperative portal embolization with administration of single liver CD133 + cells mobilized with G-CSF compared to portal embolization
    Protection of trial subjects
    Follow up for 24 months after the surgery and cell infusion
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2014
    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
    Spain: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    1
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started on September 2014 and finished on December 2020

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 4
    Number of subjects completed
    		 4

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CD133+ stem cells
    Arm description
    		 CD133+ cells administration prior to portal vein embolization (PVE)
    Arm type
    		 Experimental

    Investigational medicinal product name
    STEM CELLS PERIPHERAL BLOOD ENDOTHELIAL AUTOLOGOUS NOT EXPANDED
    Investigational medicinal product code
    CD133+
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intraportal use
    Dosage and administration details
    A dose in beteween 4 and 140x10^6 organisms administrated directly into intraportal vein

    Arm title
    		 Portal Vein embolization
    Arm description
    		 Just portal vein embolization without cells administration
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		CD133+ stem cells Portal Vein embolization
    Started
    3
    1
    Completed
    3
    1

    Baseline characteristics

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

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
        From 65-80 years
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    CD133+ stem cells
    Reporting group description
    		 CD133+ cells administration prior to portal vein embolization (PVE)

    Reporting group title
    Portal Vein embolization
    Reporting group description
    		 Just portal vein embolization without cells administration

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    There were few patients included and no one in the PVE arm, so it was no possible to perform the comparison of groups

    Primary: Evaluate the effectiveness of preoperative portal embolization with administration of single liver CD133 + cells mobilized with G-CSF compared to portal embolization

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    End point title
    		 Evaluate the effectiveness of preoperative portal embolization with administration of single liver CD133 + cells mobilized with G-CSF compared to portal embolization
    End point description
    End point type
    Primary
    End point timeframe
    Before embolization, after embolization site after surgery. The first control after PVE was performed at 2 weeks and repeated every 2 weeks until surgery. After surgery monthly until month 24 (1,3,6,12,18,24).
    End point values
    		 CD133+ stem cells Portal Vein embolization
    Number of subjects analysed
    3
    1 [1]
    Units: Liver volumes (in cubic centimeters, cc)
        number (not applicable)
    3
    1
    Notes
    [1] - The patient assignes to this arm, was not treated dut to an adverse event
    Statistical analysis title
    		 Comparation of hepatic volumes
    Statistical analysis description
    The differences between the volume means of both groups were compared with the Student-Fisher t-test after verifying the normality of the samples (using the Shapiro-Wilk normality test), or using the Mann-Whitney U-test otherwise.
    Comparison groups
    CD133+ stem cells v Portal Vein embolization
    Number of subjects included in analysis
    4
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 ≤ 0.05 [3]
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    60
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 40
         upper limit
    		 -
    Notes
    [2] - There were no patients in the PVE arm, so it was no possible to perform the comparison of groups
    [3] - There were no patients in the PVE arm, so it was no possible to perform the comparison of groups

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Since the signing of the ICF until last sudy visit of the patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Experimental Arm
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Extradural haematoma
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Abdominal abscess
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric ischaemia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Vascular disorders
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Infected skin ulcer
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2015
    Clarification about dose of cells Changes in inclusion ans exclusion criterias
    31 Aug 2015
    Identification of the entity in charged of the monitorization Clarification of the primary outcome
    26 Apr 2017
    Specification about period of window of the study visits and procedures Changes in the administrated dose

    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.
    There were few patients included in the study, just 4, and the one patient assigned to PVE was not treated due to adverse event. So it was not possible to compare the results in between both arms nor to achieve valid conclusions.
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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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