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    Clinical Trial Results:
    Matrix-associated autologous chrondrocyte transplantation for grade four cartilage lesions of the knee joint - clinical and radiological outcome in correlation to the initial cell count of the chondrocyte graft

    Summary
    EudraCT number
    		 2015-003584-11
    Trial protocol
    		 AT  
    Global end of trial date
    12 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MACT-IBK-2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Dr. Eichinger Martin, Univ.-Klinik für Orthopädie und Traumatologie Anichstraße 35 6020 Innnsbruck, 0043 51250422821, martin.eichinger@tirol-kliniken.at
    Scientific contact
    Dr. Eichinger Martin, Univ.-Klinik für Orthopädie und Traumatologie Anichstraße 35 6020 Innnsbruck, 0043 51250422821, martin.eichinger@tirol-kliniken.at
    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
    12 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the clinical and radiological outcome (MRT) after MACT and to correlate these findings with the initial cell count of the chondrocyte graft. What is more, further knowledge about additional factors influencing the outcome of the surgery may be gained. This pilot study could provide valuable data for the design of a prospective randomized clinical trial.
    Protection of trial subjects
    Die Magnetresonanztomographie (MRT) des Kniegelenkes entspricht der auch routinemäßig angewendeten MRT-Untersuchung. Bei dieser Untersuchung werden in den im Magnetfeld liegenden Körper (mindestens 1.5 Tesla) Radiowellen mit einer Frequenz von ca. 63.5 MHz gesendet. Schädliche Auswirkungen auf den menschlichen Körper sind bisher nicht bekannt geworden und aufgrund der geringen Energie der Radiowellen auch nicht anzunehmen.
    Background therapy
    		 Bei dieser Patientenpopulation ist keine Dauerbehandlung/Dauermedikation vorgesehen.
    Evidence for comparator
    		 Es gibt für diese Fragestellung keinen Komparator.
    Actual start date of recruitment
    01 Oct 2015
    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
    Austria: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In der Universitätsklinik für Unfallchirurgie wurden seit 2006, 64 Patienten mittels MACT behandelt und entsprechend einem standardisierten Protokoll nachbehandelt. Aus diesem Patientenkollektiv wurden retrospektiv alle Patienten, die den Einschlusskriterien entsprechen, ausgewählt.

    Pre-assignment
    Screening details
    		 Von den 64 Patienten wurden 42 Patienten gescreent, wovon letztendlich 28 Patienten in die Studie eingeschlossen werden konnten.

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

    Arms
    Arm title
    		 Behandlungsarm
    Arm description
    		 Inhalt dieser Studie ist die Beurteilung der Gelenksfläche nach matrix-assoziierter Chondrozytentransplantation mittels Magnetresonanztomographie sowie die Erhebung von klinischen Daten mittels einer Routineuntersuchung und mittels Patienten-Fragebögen.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATMP-Matrix associated autologous chondrocyte transplantation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implantation matrix
    Routes of administration
    Implantation
    Dosage and administration details
    Das ATMP wurde einmalig während der chirurgischen Versorgung implantiert.

    Number of subjects in period 1
    		Behandlungsarm
    Started
    28
    Completed
    27
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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

    Reporting group values
    		 Behandlung Total
    Number of subjects
    		 28 28
    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)
    		 28 28
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Behandlungsarm
    Reporting group description
    		 Inhalt dieser Studie ist die Beurteilung der Gelenksfläche nach matrix-assoziierter Chondrozytentransplantation mittels Magnetresonanztomographie sowie die Erhebung von klinischen Daten mittels einer Routineuntersuchung und mittels Patienten-Fragebögen.

    Primary: Radiologisches outcome: Defektfüllung

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    End point title
    		 Radiologisches outcome: Defektfüllung [1]
    End point description
    End point type
    Primary
    End point timeframe
    Tag 1 (MRT Untersuchung)
    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: Statistische Analysen wurden auf Grund der geringen Datenmenge nicht durchgeführt.
    End point values
    		 Behandlungsarm
    Number of subjects analysed
    27
    Units: number
    number (not applicable)
        Komplette Füllung
    23
        Inkomplette Füllung
    4
    No statistical analyses for this end point

    Primary: Radiologisches outcome: Signalintensität des Ersatzgewebes bei Dual T2-FSE

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    End point title
    		 Radiologisches outcome: Signalintensität des Ersatzgewebes bei Dual T2-FSE [2]
    End point description
    End point type
    Primary
    End point timeframe
    Tag 1 (MRT Untersuchung)
    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: Statistische Analysen wurden auf Grund der geringen Datenmenge nicht durchgeführt.
    End point values
    		 Behandlungsarm
    Number of subjects analysed
    27
    Units: number
    number (not applicable)
        Isointens
    16
        Moderat hyperintens
    8
        Nicht beurteilbar
    1
        Nicht beurteilt
    2
    No statistical analyses for this end point

    Primary: Radiologisches outcome: Erguss

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    End point title
    		 Radiologisches outcome: Erguss [3]
    End point description
    End point type
    Primary
    End point timeframe
    Tag 1 (MRT Untersuchung)
    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: Statistische Analysen wurden auf Grund der geringen Datenmenge nicht durchgeführt.
    End point values
    		 Behandlungsarm
    Number of subjects analysed
    27
    Units: Number
    number (not applicable)
        Erguss
    5
        Kein Erguss
    19
        Nicht beurteilbar
    1
        Nicht beurteilt
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Tag 1 der Untersuchung
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.3
    Reporting groups
    Reporting group title
    Behandlungsarm
    Reporting group description
    		 Inhalt dieser Studie ist die Beurteilung der Gelenksfläche nach matrix-assoziierter Chondrozytentransplantation mittels Magnetresonanztomographie sowie die Erhebung von klinischen Daten mittels einer Routineuntersuchung und mittels Patienten-Fragebögen.

    Serious adverse events
    		 Behandlungsarm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (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
    		 Behandlungsarm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 27 (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: Im Rahmen der einmaligen Studienvisite sind keine Adverse Events aufgetreten.

    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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