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    Clinical Trial Results:
    Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells

    Summary
    EudraCT number
    		 2009-017624-72
    Trial protocol
    		 ES  
    Global end of trial date
    13 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CMM/ART
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02123368
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinica Universidad de Navarra
    Sponsor organisation address
    AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
    Public contact
    UCEC, Clínica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    Scientific contact
    UCEC, Clínica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    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
    15 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the safety and feasibility of treating knee osteoarthritis by intra-articular administration of CMM cells together with hyaluronic acid (HA).
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Mar 2012
    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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    21
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 33 patients were recruited between February 2012 to November 2014 of whom 30 completed the trial.

    Pre-assignment
    Screening details
    		 Of the 30 initially planned, 33 patients were recruited to compensate for the 2 dropouts due to being recruited in the control arm and withdrawal at the discretion of the principal investigator.

    Pre-assignment period milestones
    Number of subjects started
    		 30
    Number of subjects completed
    		 30

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Intra-articular injection of Hyaluronic Acid. Single dose of 3 ml.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hyaluronic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single dose of 3 ml.

    Arm title
    		 Group B
    Arm description
    		 Low Dose. Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells grown ex-vivo (small volume sterile cell suspension (5-10 ml) in a vehicle suitable for intra-articular injection) followed by an intra-articular injection of Hiauronic Acid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ex vivo cultured autologous mesenchymal progenitor stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    10 million autologous mesenchymal progenitor stem cells cultured ex-vivo (sterile small volume cell suspension (5-10 ml) in a vehicle suitable for intra-articular injection)

    Investigational medicinal product name
    Hyaluronic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single dose of 3 ml.

    Arm title
    		 Group C
    Arm description
    		 High dose. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells grown ex-vivo (small volume sterile cell suspension (5-10 ml) in a vehicle suitable for intra-articular injection) followed by an intra-articular injection of Hiauronic Acid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ex vivo cultured autologous mesenchymal progenitor stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    100 million autologous mesenchymal progenitor stem cells cultured ex-vivo (sterile small volume cell suspension (5-10 ml) in a vehicle suitable for intra-articular injection)

    Investigational medicinal product name
    Hyaluronic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single dose of 3 ml.

    Number of subjects in period 1
    		Group A Group B Group C
    Started
    10
    10
    10
    Completed
    10
    10
    10

    Baseline characteristics

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

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 21
        From 65-84 years
    		 9 9
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Intra-articular injection of Hyaluronic Acid. Single dose of 3 ml.

    Reporting group title
    Group B
    Reporting group description
    		 Low Dose. Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells grown ex-vivo (small volume sterile cell suspension (5-10 ml) in a vehicle suitable for intra-articular injection) followed by an intra-articular injection of Hiauronic Acid.

    Reporting group title
    Group C
    Reporting group description
    		 High dose. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells grown ex-vivo (small volume sterile cell suspension (5-10 ml) in a vehicle suitable for intra-articular injection) followed by an intra-articular injection of Hiauronic Acid.

    Primary: Feasibility

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    End point title
    		 Feasibility [1]
    End point description
    End point type
    Primary
    End point timeframe
    From inclusion to treatment.
    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: It is primarily a descriptive statistic.
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    10
    10
    10
    Units: Number of patients
    10
    10
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events that occurred during the study were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Grupo A
    Reporting group description
    		 -

    Reporting group title
    Grupo B
    Reporting group description
    		 -

    Reporting group title
    Grupo C
    Reporting group description
    		 -

    Serious adverse events
    		 Grupo A Grupo B Grupo C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         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
    		 Grupo A Grupo B Grupo C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    6 / 10 (60.00%)
    9 / 10 (90.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Surgical and medical procedures
    Gastrectomy
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    3 / 10 (30.00%)
         occurrences all number
    1
    1
    3
    Arthritis
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 10 (30.00%)
    9 / 10 (90.00%)
         occurrences all number
    1
    3
    9
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (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
    04 Apr 2011
    Expansion of a new center: Salamanca
    05 Jul 2012
    Change of sponsor.
    05 Dec 2012
    Recruitment increase
    21 May 2014
    Change of principal investigator.
    01 Jul 2014
    New IMP

    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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