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    Clinical Trial Results:
    A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures.

    Summary
    EudraCT number
    		 2011-005584-24
    Trial protocol
    		 BE   NL  
    Global end of trial date
    26 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Nov 2019
    First version publication date
    02 Nov 2019
    Other versions
    Summary report(s)
    		 synoptic clinical sudy report

    Trial information

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    Trial identification
    Sponsor protocol code
    PREOB-NU3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bone Theapeutics S.A.
    Sponsor organisation address
    rue Auguste Picard 37, Gosselies, Belgium, B-6041
    Public contact
    Clinical Trial Information, Bone Therapeutics S.A., preob.nu3@bonetherapeutics.com
    Scientific contact
    Clinical Trial Information, Bone Therapeutics S.A., preob.nu3@bonetherapeutics.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
    10 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of the study are to demonstrate the non-inferiority of PREOB® implantation over bone autograft in terms of safety and efficacy at Month 12 clinically on the basis of the global disease evaluation score (as assessed by visual analogue scales) and radiologically on the basis of the percentage of patients with radiological improvement as assessed by RUST score determined by CT Scan.
    Protection of trial subjects
    GCP
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 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
    Belgium: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The PREOB-NU3 study was terminated early (25 September 2017 (Belgium (BE) / 17 July 2015 (France (FR); Study termination for refusal of study extension by CCP) / 22 Augustus 2016 (The Netherlands (NL)) by the sponsor with <10% of planned subject enrolled because of recruitment difficulties.

    Pre-assignment
    Screening details
    		 Of the 16 subjects enrolled in the study, 9 (56.25%) subjects were screen failure

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Preob
    Arm description
    		 Test item
    Arm type
    		 Experimental

    Investigational medicinal product name
    Preob
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    Single dose, 4 x 10exp6 cells/mL

    Arm title
    		 Bone autograft
    Arm description
    		 Active comparator
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bone autograft
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    Bone autograft

    Number of subjects in period 1
    		Preob Bone autograft
    Started
    2
    3
    Completed
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Preob
    Reporting group description
    		 Test item

    Reporting group title
    Bone autograft
    Reporting group description
    		 Active comparator

    Reporting group values
    		 Preob Bone autograft Total
    Number of subjects
    		 2 3 5
    Age categorical
    Units: Subjects
        Adult
    		 2 3 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.2 ± 7.3 45.7 ± 10.3 -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1
        Male
    		 2 2 4
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Safety and efficacy population

    Subject analysis sets values
    		 ITT
    Number of subjects
    5
    Age categorical
    Units: Subjects
        Adult
    5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.32 ± 9.4
    Gender categorical
    Units: Subjects
        Female
    1
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    Preob
    Reporting group description
    		 Test item

    Reporting group title
    Bone autograft
    Reporting group description
    		 Active comparator

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Safety and efficacy population

    Primary: Achievement of Union

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    End point title
    		 Achievement of Union [1]
    End point description
    Achievement of fracture healing (union)
    End point type
    Primary
    End point timeframe
    12 months
    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: The study was interrupted and no analysis of efficacy was performed
    End point values
    		 Preob Bone autograft ITT
    Number of subjects analysed
    2
    3
    5
    Units: Patient
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.1
    Reporting groups
    Reporting group title
    Preob
    Reporting group description
    		 Test

    Reporting group title
    Bone autograft
    Reporting group description
    		 Active comparator

    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: The non-serious adverse events will be filled in at a later stage
    Serious adverse events
    		 Preob Bone autograft
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 3 (66.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Medical device change
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 3 (66.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Preob Bone autograft
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)

    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? Yes
    Date
    Interruption
    Restart date
    25 Sep 2017
    the clinical trial was prematurely stoped to focus resources in the allogeneic platform and provide optimal value for patients
    -

    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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