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    Clinical Trial Results:
    Mesenchymal stem cells for radiation-induced xerostomia (MESRIX) in previous HPV-positive oropharyngeal head and neck cancer patients

    Summary
    EudraCT number
    2014-004349-29
    Trial protocol
    DK  
    Global end of trial date
    03 Jun 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Aug 2021
    First version publication date
    20 Aug 2021
    Other versions
    Summary report(s)
    Paper

    Trial information

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    Trial identification
    Sponsor protocol code
    01-10-2014
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark,
    Public contact
    Rigshospitalet, Dept. of Otolaryngology, Head and Neck surgery, 0045 35452071, christian.von.buchwald@regionh.dk
    Scientific contact
    Rigshospitalet, Dept. of Otolaryngology, Head and Neck surgery, 0045 35452071, christian.von.buchwald@regionh.dk
    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 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective is to examine whether enrichment of the submandibular gland with injection of autologous ASC will improve the result of salivary function in radiation-induced gland hypofunction.
    Protection of trial subjects
    None
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jan 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy, Ethical reason, Regulatory reason, Scientific research
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    23
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Eligibility criteria included previous radio- therapy, with or without concomitant chemotherapy, for a human papilloma virus-positive, T1-T2, and N0, N1, or N2A oropharyngeal squamous cell carcinoma; (12) two years of follow-up without disease progression; an unstimulated whole saliva flow rate in the range of 0.05 to 0.20 ml/min, correspon

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ASC arm
    Arm description
    Intervention
    Arm type
    Experimental

    Investigational medicinal product name
    Mesenchymal stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    injection of 2.8 million ASCs/cm3 pr gland

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    saline with 1% human albumin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    2 ml in each submandibular gland

    Number of subjects in period 1
    ASC arm Placebo
    Started
    17
    16
    Completed
    15
    15
    Not completed
    2
    1
         Consent withdrawn by subject
    -
    1
         failed to expand ASCs
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ASC arm
    Reporting group description
    Intervention

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    ASC arm Placebo Total
    Number of subjects
    17 16 33
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    13 10 23
        From 65-84 years
    4 6 10
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    6 11 17
        Male
    11 5 16
    Subject analysis sets

    Subject analysis set title
    Experimental arm
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects randomized to experimental arm

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects randomized to placebo arm

    Subject analysis sets values
    Experimental arm Placebo
    Number of subjects
    15
    15
    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)
    11
    9
        From 65-84 years
    4
    6
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    6
    5
        Male
    9
    10

    End points

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    End points reporting groups
    Reporting group title
    ASC arm
    Reporting group description
    Intervention

    Reporting group title
    Placebo
    Reporting group description
    -

    Subject analysis set title
    Experimental arm
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects randomized to experimental arm

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects randomized to placebo arm

    Primary: Safety

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    End point title
    Safety
    End point description
    End point type
    Primary
    End point timeframe
    4 months
    End point values
    ASC arm Placebo Experimental arm Placebo
    Number of subjects analysed
    15
    15
    15
    15
    Units: Adverse events
    0
    0
    0
    0
    Statistical analysis title
    Primary endpoints
    Statistical analysis description
    For salivary flow rates, patient-reported outcome measures, and tissue type analysis we evaluated the changes from baseline to the one- and four-month follow-up visits. Within-group comparisons were performed with the Wil- coxon signed-rank test, and between-group comparisons were performed with the Mann-Whitney U test. We chose to use non parametric statistics as the data were not nor- mally distributed, evaluated by Shapiro-Wilks tests.
    Comparison groups
    ASC arm v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Unstimulated whole saliva flow

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    End point title
    Unstimulated whole saliva flow
    End point description
    Unstimulated whole salivary flow rates significantly increased in the ASC-arm at one (33%; P Z .048) and four months (50%; P Z .003), but not in the placebo-arm (P Z .6 and P Z .8), compared to baseline.
    End point type
    Secondary
    End point timeframe
    4 months
    End point values
    Experimental arm Placebo
    Number of subjects analysed
    Units: ml/min
        number (not applicable)
    50
    33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    4 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    -

    Serious adverse events
    All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    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: There were no.

    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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