Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Treatment of osteoarthritis with allogeneic mesenchymal cells (MSV).

    Summary
    EudraCT number
    		 2011-005321-51
    Trial protocol
    		 ES  
    Global end of trial date
    15 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Oct 2021
    First version publication date
    01 Oct 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MSV-ALLO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Parque Científico de la Universidad de Valladolid
    Sponsor organisation address
    Edificio I+D, Paseo de Belén, 11, Campus Miguel Delibes, Valladolid, Spain, 47011
    Public contact
    Dr. Javier García-Sancho Martín, Parque Científico de la Universidad de Valladolid, +34 912948910, enrique.conde@efficeresearch.com
    Scientific contact
    Dr. Javier García-Sancho Martín, Parque Científico de la Universidad de Valladolid, +34 912948910, enrique.conde@efficeresearch.com
    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 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the feasibility and safety of allogeneic MSV applied by percutaneous injection in the knee joint as a treatment for osteoarthritis of the knee
    Protection of trial subjects
    The study was in compliance with ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local requirements pertinent to safety of trial subjects were also followed during the conduct of the trial
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    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)
    24
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 30 patients were enrolled at 1 investigational site. 30 patients were randomized, 15 to MSV-Allo and 15 to Hyaluronic acid. All patients were treated. Patients participated between 26/07/2012 and 12/12/2012 (last follow-up).

    Pre-assignment
    Screening details
    		 IC signed; Aged>=18;Gonarthrosis grade>=2;Chronic painful knee mechanical properties;No local or systemic septic process;Hematological and biochemical analysis without significant alterations.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    An online randomisation service was used. Only the investigator who implant the cells were unblind to the allocation. The MSV-ALLO and Hyaluronic acid were identical and so there was no danger of study staff or participants being unblinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MSV-ALLO
    Arm description
    		 Single dose 10 ml with celular dose: 40 millions ± 8 millions of Mesenchymal stem cell
    Arm type
    		 Experimental

    Investigational medicinal product name
    MSV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single dose 10 ml with celular dose: 40 millions ± 8 millions of Mesenchymal stem cell

    Arm title
    		 Hyaluronic Acid
    Arm description
    		 Single dose of 60 mg of Hyaluronic Acid in 3 ml of Durolane
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hyaluronic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single dose of 60 mg of Hyaluronic Acid in 3 ml of Durolane

    Number of subjects in period 1
    		MSV-ALLO Hyaluronic Acid
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    MSV-ALLO
    Reporting group description
    		 Single dose 10 ml with celular dose: 40 millions ± 8 millions of Mesenchymal stem cell

    Reporting group title
    Hyaluronic Acid
    Reporting group description
    		 Single dose of 60 mg of Hyaluronic Acid in 3 ml of Durolane

    Reporting group values
    		 MSV-ALLO Hyaluronic Acid Total
    Number of subjects
    		 15 15 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12 24
        From 65-84 years
    		 3 3 6
    Age continuous
    Units: years
        median (full range (min-max))
    		 56 (38 to 73) 59 (51 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 7 10 17
        Male
    		 8 5 13
    Previous intraarticular treatment of knee osteoarthritis
    Units: Subjects
        Yes
    		 5 8 13
        No
    		 10 7 17
    Previous oral tretament of knee osteoarthritis
    Units: Subjects
        Yes
    		 15 14 29
        No
    		 0 1 1
    Kellgren and Lawrence system
    The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades: Gr 0 none: definite absence of x-ray changes of OA Gr 1 doubtful: doubtful joint space narrowing and possible osteophytic lipping Gr 2 minimal: definite osteophytes and possible joint space narrowing Gr 3 moderate: moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends Gr 4 severe: large osteophytes, marked narrowing of joint space, severe sclerosis and definite definite deformity of bone ends
    Units: Subjects
        Minimal
    		 6 6 12
        Moderate
    		 6 5 11
        Severe
    		 3 3 6
        Unknown
    		 0 1 1
    Knee treated
    Units: Subjects
        Right
    		 10 12 22
        Left
    		 5 3 8
    Weight
    Units: Kg
        median (full range (min-max))
    		 70 (56 to 89) 70 (55 to 83) -
    Height
    Units: cm
        median (full range (min-max))
    		 164 (156 to 180) 163 (145 to 176) -
    Body mass index
    Units: kg/m^2
        median (full range (min-max))
    		 25.6 (21.9 to 30.0) 27.7 (20.6 to 30.1) -
    WOMAC index (pain)
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68).
    Units: points
        median (full range (min-max))
    		 42.8 (23.5 to 70.0) 50.7 (20.3 to 71.2) -
    WOMAC index (stiffness)
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68).
    Units: points
        median (full range (min-max))
    		 29.5 (2.5 to 76.5) 49.5 (8.0 to 85.0) -
    WOMAC index (Physical functioning)
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68).
    Units: points
        median (full range (min-max))
    		 39.2 (21.3 to 62.8) 48.3 (21.0 to 63.5) -
    Lequesne questionnaires
    Lequesne questionnaires is a self-report questionnaire instruments for patients with knee disabilities.
    Units: points
        median (full range (min-max))
    		 37.5 (17.0 to 66.7) 45.8 (12.5 to 62.5) -
    Health Assessment Questionnaire
    Units: points
        median (full range (min-max))
    		 0.5 (0.0 to 1.1) 0.8 (0.0 to 1.3) -
    Quality of life
    SF-12 v2 questionaire
    Units: points
        median (full range (min-max))
    		 58.8 (27.1 to 86.4) 27.1 (1.3 to 58.8) -
    Visual Analogue Scale
    Units: points
        median (full range (min-max))
    		 55.0 (15.0 to 81.0) 70.0 (4.0 to 97.0) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    MSV-ALLO
    Reporting group description
    		 Single dose 10 ml with celular dose: 40 millions ± 8 millions of Mesenchymal stem cell

    Reporting group title
    Hyaluronic Acid
    Reporting group description
    		 Single dose of 60 mg of Hyaluronic Acid in 3 ml of Durolane

    Primary: Magnetic resonance imaging changes at 12 months

    		 Close Top of page
    End point title
    		 Magnetic resonance imaging changes at 12 months
    End point description
    End point type
    Primary
    End point timeframe
    at 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    12 [1]
    15
    Units: subjects
        Improvement
    10
    11
        No changes
    0
    1
        Get worse
    2
    3
    Notes
    [1] - No RMI performed
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6618
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Magnetic resonance imaging changes at 6 months

    		 Close Top of page
    End point title
    		 Magnetic resonance imaging changes at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    13 [2]
    15
    Units: subjects
        Improvement
    11
    11
        No changes
    2
    0
        Get worse
    0
    4
    Notes
    [2] - 2 No RMI performed
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6546
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Change in WOMAC index (pain)

    		 Close Top of page
    End point title
    		 Change in WOMAC index (pain)
    End point description
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68).
    End point type
    Secondary
    End point timeframe
    At day 8, 3 months, 6 months and 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    15
    15
    Units: points
    arithmetic mean (standard deviation)
        Day 8
    -6.96 ± 12.3
    -2.88 ± 13.8
        3 months
    -10.01 ± 23.7
    -4.27 ± 17.2
        6 months
    -13.02 ± 19.0
    -5.97 ± 12.1
        12 months
    -16.30 ± 23.0
    -6.36 ± 15.8
    Statistical analysis title
    		 Differences between groups at day 8
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2144
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 3 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2368
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 6 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1289
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 12 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0667
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in WOMAC index (stiffness)

    		 Close Top of page
    End point title
    		 Change in WOMAC index (stiffness)
    End point description
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68).
    End point type
    Secondary
    End point timeframe
    At day 8, 3 months, 6 months and 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    15
    15
    Units: points
    arithmetic mean (standard deviation)
        Day 8
    0.37 ± 21.9
    0.13 ± 23.0
        3 months
    -4.77 ± 30.5
    -1.93 ± 25.2
        6 months
    -3.17 ± 23.8
    -2.87 ± 23.6
        12 months
    -10.67 ± 31.1
    -4.50 ± 29.5
    Statistical analysis title
    		 Differences between groups at day 8
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3944
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 3 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3039
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 6 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4022
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 12 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2218
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in WOMAC index (Physical functioning)

    		 Close Top of page
    End point title
    		 Change in WOMAC index (Physical functioning)
    End point description
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68).
    End point type
    Secondary
    End point timeframe
    At day 8, 3 months, 6 months and 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    15
    15
    Units: points
    arithmetic mean (standard deviation)
        Day 8
    -6.60 ± 19.0
    -1.43 ± 13.1
        3 months
    -8.51 ± 22.8
    -6.46 ± 18.7
        6 months
    -14.53 ± 19.8
    -6.97 ± 20.5
        12 months
    -12.59 ± 23.1
    -4.26 ± 21.3
    Statistical analysis title
    		 Differences between groups at day 8
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2216
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 3 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5188
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 6 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1085
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 12 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1648
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in Lequesne index

    		 Close Top of page
    End point title
    		 Change in Lequesne index
    End point description
    End point type
    Secondary
    End point timeframe
    At day 8, 3 months, 6 months and 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    15
    15
    Units: points
    arithmetic mean (standard deviation)
        Day 8
    -3.38 ± 12.1
    -1.66 ± 9.2
        3 months
    -3.63 ± 12.4
    -5.18 ± 12.8
        6 months
    -13.95 ± 10.8
    -5.46 ± 13.4
        12 months
    -8.76 ± 12.4
    -3.13 ± 12.6
    No statistical analyses for this end point

    Secondary: Change in Health Assessment Questionnaire

    		 Close Top of page
    End point title
    		 Change in Health Assessment Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    At day 8, 3 months, 6 months and 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    15
    15
    Units: points
    arithmetic mean (standard deviation)
        Day 8
    0.13 ± 0.3
    -0.13 ± 0.3
        3 months
    -0.01 ± 0.2
    -0.19 ± 0.4
        6 months
    -0.13 ± 0.2
    -0.19 ± 0.4
        12 months
    -0.07 ± 0.3
    -0.12 ± 0.5
    Statistical analysis title
    		 Differences between groups at day 8
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0701
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 3 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3783
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 6 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.699
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 12 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9627
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in Quality of life

    		 Close Top of page
    End point title
    		 Change in Quality of life
    End point description
    End point type
    Secondary
    End point timeframe
    At day 8, 3 months, 6 months and 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    15
    15
    Units: points
    arithmetic mean (standard deviation)
        Day 8
    2.11 ± 14.5
    2.11 ± 14.5
        3 months
    0.12 ± 22.5
    0.39 ± 16.2
        6 months
    10.64 ± 22.8
    2.11 ± 21.2
        12 months
    5.24 ± 27.9
    2.51 ± 21.1
    Statistical analysis title
    		 Differences between groups at day 8
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4705
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 3 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4603
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 6 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0973
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 12 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2951
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in VAS scale

    		 Close Top of page
    End point title
    		 Change in VAS scale
    End point description
    End point type
    Secondary
    End point timeframe
    At day 8, 3 months, 6 months and 12 months from administration
    End point values
    		 MSV-ALLO Hyaluronic Acid
    Number of subjects analysed
    15
    15
    Units: points
    arithmetic mean (standard deviation)
        Day 8
    -4.47 ± 22.4
    -1.93 ± 16.1
        3 months
    -13.67 ± 30.7
    -7.53 ± 23.6
        6 months
    -20.67 ± 29.3
    -11.93 ± 20.6
        12 months
    -21.20 ± 28.5
    -13.07 ± 21.6
    Statistical analysis title
    		 Differences between groups at day 8
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3409
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 3 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2831
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 6 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1371
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Differences between groups at 12 months
    Comparison groups
    MSV-ALLO v Hyaluronic Acid
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2041
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    MSV-ALLO
    Reporting group description
    		 Single dose 10 ml with celular dose: 40 millions ± 8 millions of Mesenchymal stem cell

    Reporting group title
    Hyaluronic Acid
    Reporting group description
    		 Single dose of 60 mg of Hyaluronic Acid in 3 ml of Durolane

    Serious adverse events
    		 MSV-ALLO Hyaluronic Acid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MSV-ALLO Hyaluronic Acid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 15 (93.33%)
    13 / 15 (86.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Neoplasms
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Dental implantation
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Effusion
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Testicular pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Premature menopause
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Menorrhagia
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 15 (0.00%)
    11 / 15 (73.33%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Blefaritis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Erosión corneal
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dental pain
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 15 (80.00%)
    11 / 15 (73.33%)
         occurrences all number
    8
    9
    Joint effusion
         subjects affected / exposed
    3 / 15 (20.00%)
    5 / 15 (33.33%)
         occurrences all number
    2
    4
    Back pain
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 15 (13.33%)
         occurrences all number
    2
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Arthritis
         subjects affected / exposed
    3 / 15 (20.00%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Infections and infestations
    Ear infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 23:25:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA