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    Clinical Trial Results:
    A phase IIa, unicenter, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrphic pseudoarthrosis of long bones

    Summary
    EudraCT number
    		 2013-005025-23
    Trial protocol
    		 ES  
    Global end of trial date
    20 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2022
    First version publication date
    18 May 2022
    Other versions
    Summary report(s)
    		 A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stro

    Trial information

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    Trial identification
    Sponsor protocol code
    XCEL-PSART-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Banc de Sang i Teixits
    Sponsor organisation address
    Passeig Taulat 116, Barcelona, Spain, 08005
    Public contact
    Ruth Coll Bonet, Responsible for Clinical Development, Banc de Sang i Teixits (BST), +34 935573500, rucoll@bst.cat
    Scientific contact
    Ruth Coll Bonet, Responsible for Clinical Development, Banc de Sang i Teixits (BST), +34 935573500, rucoll@bst.cat
    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
    05 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    -To assess the efficacy of XCEL-MT-OSTEO-ALPHA in the treatment of non-hypertrophic pseudarthrosis of long bones through quantifying of the Hounsfield units by TC at month 12 postreatment.
    Protection of trial subjects
    Patients were sedated and locally anesthesied for the bone marrow extraction and were discharged after recovery.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 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
    Spain: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between January 2015 and February 2018 in a single centre (Hospital ASEPEYO Sant Cugat (Barcelona)).

    Pre-assignment
    Screening details
    		 Patients between 18 and 65 years of age affected with acquired metaphysodiaphyseal non-hypertrophic pseudoarthrosis of long bones, visited at Hospital ASEPEYO Sant Cugat (Barcelona)

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    As the tested product is from autologous bone marrow meaning randomised patients had to undergo for a previous bone marrow extraction, the only person that could be blinded was the radiologist who assessed the radiological images.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 XCEL-MT-OSTEO-ALPHA
    Arm description
    		 Mechanical stabilization and XCEL-MT-OSTEO-ALPHA (ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue).
    Arm type
    		 Experimental

    Investigational medicinal product name
    XCEL-MT-OSTEO-ALPHA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Local use
    Dosage and administration details
    Product: XCEL-MT-OSTEO-ALPHA • Dose: 3x105 y 1x106 mesenchymal stromal cells per cubic centimeter of bone (5 or 10 cc) • Pharmaceutical form: Solid particles. • Administration route: Surgically implanted • Administration periodicity: Single dose.

    Arm title
    		 Standar of care
    Arm description
    		 Mechanical stabilization and autologous graft
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Autologous graft
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Local use
    Dosage and administration details
    Autologous graft. Dosage is not applicable.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Being an autologous treatment requiring previous bone marrow extraction, the only person that could be blind was the radiologist.
    Number of subjects in period 1
    		XCEL-MT-OSTEO-ALPHA Standar of care
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    XCEL-MT-OSTEO-ALPHA
    Reporting group description
    		 Mechanical stabilization and XCEL-MT-OSTEO-ALPHA (ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue).

    Reporting group title
    Standar of care
    Reporting group description
    		 Mechanical stabilization and autologous graft

    Reporting group values
    		 XCEL-MT-OSTEO-ALPHA Standar of care Total
    Number of subjects
    		 10 10 20
    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)
    		 10 10 20
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.7 ( 9.9 ) 51.8 ( 7.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 2 3
        Male
    		 9 8 17

    End points

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    End points reporting groups
    Reporting group title
    XCEL-MT-OSTEO-ALPHA
    Reporting group description
    		 Mechanical stabilization and XCEL-MT-OSTEO-ALPHA (ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue).

    Reporting group title
    Standar of care
    Reporting group description
    		 Mechanical stabilization and autologous graft

    Primary: Change in mean percentage of Housfield Units by CT

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    End point title
    		 Change in mean percentage of Housfield Units by CT
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    7
    8
    Units: percent
        arithmetic mean (standard deviation)
    46 ( 19.25 )
    54.39 ( 21.63 )
    Statistical analysis title
    		 Change in mean percentage of HU
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4835
    Method
    		 Regression, Linear
    Confidence interval
    Statistical analysis title
    		 Change in mean percentage of HU
    Comparison groups
    Standar of care v XCEL-MT-OSTEO-ALPHA
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4835
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: Change in mean percentage of Housfield Units by CT

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    End point title
    		 Change in mean percentage of Housfield Units by CT
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    8
    8
    Units: percent
        arithmetic mean (standard deviation)
    29.70 ( 13.86 )
    40.50 ( 19.88 )
    Statistical analysis title
    		 Change in mean percentage of HU
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3761
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: Degree of consolidation according to TUS scale (Tomographic union Score)

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    End point title
    		 Degree of consolidation according to TUS scale (Tomographic union Score)
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    8
    8
    Units: Units
        Consolidated
    1
    5
        Not consolidated
    7
    3
    Statistical analysis title
    		 degree of consolidation according to TUS scale
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.119
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Degree of consolidation according to TUS scale (Tomographic union Score)

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    End point title
    		 Degree of consolidation according to TUS scale (Tomographic union Score)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    7
    8
    Units: Units
        Consolidated
    3
    6
        Not consolidated
    4
    2
    Statistical analysis title
    		 degree of consolidation according to TUS scale
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.315
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Degree of consolidation according to RUS scale (Radiograhic Union Score)

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    End point title
    		 Degree of consolidation according to RUS scale (Radiograhic Union Score)
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    8
    8
    Units: Units
        Consolidated
    4
    5
        Not Consolidated
    4
    3
    Statistical analysis title
    		 degree of consolidation according to RUS scale
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Degree of consolidation according to RUS scale (Radiograhic Union Score)

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    End point title
    		 Degree of consolidation according to RUS scale (Radiograhic Union Score)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    7
    8
    Units: Units
        Consolidated
    5
    7
        Not consolidated
    2
    1
    Statistical analysis title
    		 degree of consolidation according to RUS scale
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.569
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Changes in the EUROQoL-5D

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    End point title
    		 Changes in the EUROQoL-5D
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    8
    8
    Units: mean
        arithmetic mean (standard deviation)
    0.6217 ( 0.2248 )
    0.5451 ( 0.1931 )
    Statistical analysis title
    		 Changes in punctuation on the Euroqol-5D
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3708
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: Changes in the EUROQoL-5D

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    End point title
    		 Changes in the EUROQoL-5D
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 XCEL-MT-OSTEO-ALPHA Standar of care
    Number of subjects analysed
    8
    7
    Units: mean
        arithmetic mean (standard deviation)
    0.5795 ( 0.1782 )
    0.7176 ( 0.2060 )
    Statistical analysis title
    		 Changes in the EUROQoL-5D
    Comparison groups
    XCEL-MT-OSTEO-ALPHA v Standar of care
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4204
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from the signature of the informed consent form to the end of the trial
    Adverse event reporting additional description
    Safety analyzes were performed with the available data, without using missing data imputation techniques. The analysis techniques were descriptive, including graphs and individual data listings. The AE were described by means of lists of the AE, organized by treatment group and patient, which included the preferred terms (MedDRA), as well as the c
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    XCEL-MT-OSTEO-ALPHA
    Reporting group description
    		 Patients randomized to XCEL-MT-OSTEO-ALPHA

    Reporting group title
    STANDARD OF CARE
    Reporting group description
    		 Patients randomized to standard of care treatment (autologous iliac creast)

    Serious adverse events
    		 XCEL-MT-OSTEO-ALPHA STANDARD OF CARE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 10 (20.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Medical device site joint pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pseudarthrosis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    postprocedural infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 XCEL-MT-OSTEO-ALPHA STANDARD OF CARE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    4 / 10 (40.00%)
    Injury, poisoning and procedural complications
    Post procedural discomfort
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Limb operation
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dysaesthesia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Medical device site discomfort
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Discomfort
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gait disturbance
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Medical device site joint discomfort
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Medical device site pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Encopresis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal discomfort
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Pain in extremity
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Back pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Muscle atrophy
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Muscle contracture
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2015
    The dose to be used in this study was increased from 10 to 20 cc, with a minimum cell content of 30x105 and a maximum of 20x106

    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.

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