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    Clinical Trial Results:
    A Pilot Phase IIa, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Rescue Interbody Fusion

    Summary
    EudraCT number
    		 2014-002416-16
    Trial protocol
    		 BE  
    Global end of trial date
    25 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2021
    First version publication date
    14 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ALLOB-RIF1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02328287
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bone Therapeutics S.A.
    Sponsor organisation address
    Rue Auguste Piccard, 37, Gosselies, Belgium, 6041
    Public contact
    Clinical Trial Information, Bone Therapeutics S.A., regulatory@bonetherapeutics.com
    Scientific contact
    Clinical Trial Information, Bone Therapeutics S.A., regulatory@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
    26 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the safety and efficacy of ALLOB® in rescue interbody fusion over 12 months in patients suffering from failed lumbar fusion at one or two level(s). Safety: At each visit, subjects will be assessed for the potential occurrence of any AE or SAE related to the product or to the procedure, using patient open non-directive questionnaires, vital signs and laboratory measurements. Efficacy: The efficacy of the treatment will be evaluated at Month 12: - Radiologically (progression of the lumbar fusion): the Fusion Score as assessed by CT-scan vs. baseline. - Clinically (functional disability): the changes in ODI 2.1a vs. baseline.
    Protection of trial subjects
    Standard-of-care treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Feb 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 17 February 2015 - 17 March 2017 Country: Belgium

    Pre-assignment
    Screening details
    		 Men and women aged 18 years or more at the time of implantation, diagnosed with failed lumbar fusion at one or two level(s) of a minimum of 15 months following the interbody fusion, and requiring a rescue surgery.

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

    Arms
    Arm title
    		 ALLOB
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALLOB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraosseous use
    Dosage and administration details
    One single administration of ALLOB (4mL - 100x10^6 cells) per lumbar level with a maximum of two treated levels

    Number of subjects in period 1 [1]
    		ALLOB
    Started
    6
    Completed
    5
    Not completed
    1
         Consent withdrawn by subject
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 10 patients enrolled in the study, 8 were eligible and 2 were screened failure. Of the 8 eligible patients, 6 were treated and 2 were not due to technical issues during the implantation procedure. The abbreviated CSR contains only the analysed data for the 6 treated patients.

    Baseline characteristics

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

    Reporting group values
    		 ALLOB Total
    Number of subjects
    		 6 6
    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)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Not recorded
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.4 ( 9.58 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 3 3
        Not recorded
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All treated patients were included in the safety population.

    Subject analysis sets values
    		 Safety population
    Number of subjects
    6
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    6
        From 65-84 years
        85 years and over
        Not recorded
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.4 ( 9.58 )
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    3
        Not recorded

    End points

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    End points reporting groups
    Reporting group title
    ALLOB
    Reporting group description
    		 -

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All treated patients were included in the safety population.

    Primary: Changes in fusion score and ODI 2.1 vs. baseline

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    End point title
    		 Changes in fusion score and ODI 2.1 vs. baseline [1]
    End point description
    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 early terminated. The low number of subjects treated (N=6) did not allow appropriate or meaningful statistical analysis of the ALLOB® efficacy data.
    End point values
    		 ALLOB Safety population
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Patient
    Notes
    [2] - early termintation of the study
    [3] - early termination of the study
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the treatment date till the end of long-term safety follow-up (36 months after the treatment)
    Adverse event reporting additional description
    Open questionnaires, physical examination, vital signs, laboratory parameters, AEs/SAEs at each visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Toe operation
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Central pain syndrome
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    Investigations
    Blood calcium decreased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Vitamin D decreased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Patella fracture
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Rib fracture
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Varicose vein
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Surgical and medical procedures
    Toe operation
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Wedge resection toenail
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nervous system disorders
    Central pain syndrome
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Hiatus hernia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    7
    Musculoskeletal pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Osteoarthritis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3
    Periarthritis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Spinal pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Tendonitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    6
    Infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    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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