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    Clinical Trial Results:
    NDisc Study: A Prospective Randomized Multicentre Phase I / II Clinical Trial to Evaluate Safety and Efficacy of NOVOCART® Disc plus Autologous Disc Chondrocyte Transplantation (ADCT) in the Treatment of Nucleotomized and Degenerative Lumbar Discs to Avoid Secondary Disease

    Summary
    EudraCT number
    		 2010-023830-22
    Trial protocol
    		 DE   AT  
    Global end of trial date
    14 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2022
    First version publication date
    15 Oct 2022
    Other versions
    Summary report(s)
    		 Synoptic Clinical Study Report AAG-G-H-1102
    AAG-G-H-1102 Listings
    AAG-G-H-1102 Tables

    Trial information

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    Trial identification
    Sponsor protocol code
    AAG-G-H-1102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01640457
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TETEC AG
    Sponsor organisation address
    Aspenhaustr. 18, Reutlingen, Germany, 72770
    Public contact
    Simone Steinert, Study Manager, TETEC AG, 0049 071211626 203, simone.steinert@tetec-ag.de
    Scientific contact
    Dr. Christoph Gaissmaier, CMO, TETEC AG, 0049 071211626 201, christoph.gaissmaier@tetec-ag.de
    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
    31 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To characterize the safe use of the investigational medicinal product and the transplantation/implantation procedures. • To characterize the cumulative functional and radiographic effects of NDplus over NDbasic and SC. • To characterize the effect of NDbasic alone over SC. • To characterize the effect of the investigational medicinal product on the adjacent de-generative discs. • To define metabolic parameters that measure identity, purity, and potency of the extracted tissue, of the isolated cells, and of the in vitro expanded cells. • To define metabolic parameters in subjects to control the status of tissue repair. • To define metabolic parameters in patients to control the status of tissue repair • To define the prognostic value of metabolic and radiological parameters in the context of disc degeneration, functional status, and quality of life
    Protection of trial subjects
    NDisc plus application: The required biomaterial for the cell culture is extracted in the context of an elective sequestrectomy. The material is taken from the extracted disc and therefore a by-product of the elective sequestrectomy with no additional risk for the patient. Nutrition solution for cultivation of human chondrocytes contains a small amount of homologous serum, which is manufactured by Transfusion Medicine Tuebingen. EU-GMP-guidelines are fully applied. The injection needle for the implantation must be inserted into the remaining disc tissue under the image converter tube (X-ray unit). The administered radiation dose is about the same as that of 2x-ray-chest images. For NDplus and NDbasic patients female patients are required to take contraceptive measures until the end of the therapy phase. Pregnancy tests are performed prior to sequestrectomy and prior implantation. Local anaesthesia prior to implantation were conducted. Investigators are specially trained for the process of implantation.
    Background therapy
    		 Standard of care treatment: Sequestrectomy
    Evidence for comparator
    		 NOVOCART® Disc plus (NDplus) was developed to provide rehydration and biological integrity of degenerative lumbar discs to prevent secondary disease such as disc herniation and segmental instability. It was hypothesized that by transplanting disc derived chondrocytes into degenerative discs, where the cells will be held in situ re-differentiate and produce new cartilaginous tissue. Thus patients were expected to experience better outcomes as compared to control (standard care [SC] sequestrectomy). NOVOCART® Disc basic (NDbasic) alone has no active cell component, its hydrophilic characteristics and specific ingredients for influencing cell metabolism and anti-inflammatory as well as anti-angiogenic, anti-osteogenic, and anti-neurotropic milieu conditioning has a potential for disc regeneration and effective pain treatment.
    Actual start date of recruitment
    07 Oct 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 46
    Country: Number of subjects enrolled
    Germany: 74
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    120
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 FPFV: 07-OCT-2012 LPFV: 16-MAR-2016 Austria: Innsbruck Germany: Halle, Düsseldorf, Murnau, Berlin DRK, Karlsruhe, Münster, Kiel, Berlin Chrité, Idar-Oberstein, Göttingen

    Pre-assignment
    Screening details
    		 1. The patient has a disc herniation with back and/or leg pain (radicular pain) 2. The patient has an indication for sequestrectomy according to the guidelines of DGNC and DGOOC (Börm, Steiger, Papavero, Herdmann, Ohmann, & Schwedtfeger, 2005. 3. The patient is between 18-60 years of age.

    Period 1
    Period 1 title
    Phase I/II (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Assessor blinded for MRI analysis

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NDplus
    Arm description
    		 Patients who receive NOVOCART Disc plus (acitve cells)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NOVOCART Disc plus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implantation suspension
    Routes of administration
    Implantation, Injection
    Dosage and administration details
    In situ cross-linking modified albumin-hyaluronic acid gel with autologous disc cells (1 mio. intervertebral disc chondrocytes/ml). The volume of the injection depends on the capacity of the treated disc. It may vary between 0.5 and 2 ml.

    Arm title
    		 NDbasic
    Arm description
    		 Patients who receive NOVOCART Basic (no active cells)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NOVOCART Disc basic
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implantation suspension
    Routes of administration
    Implantation, Injection
    Dosage and administration details
    In situ cross-linking modified albumin-hyaluronic acid gel. The volume of the injection depends on the capacity of the treated disc. It may vary between 0.5 and 2 ml.

    Arm title
    		 Standard of Care (SC)
    Arm description
    		 Patients who received standard of care, sequestrectomy only.
    Arm type
    		 Standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		NDplus NDbasic Standard of Care (SC)
    Started
    58
    37
    25
    Completed
    58
    37
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase I/II
    Reporting group description
    		 -

    Reporting group values
    		 Phase I/II Total
    Number of subjects
    		 120 120
    Age categorical
    Patients aged 18 to 60 years
    Units: Subjects
        Adults aged 18 to 60 years
    		 120 120
    Age continuous
    18 to 60 years
    Units: years
        arithmetic mean (standard deviation)
    		 41.7 ( 10.54 ) -
    Gender categorical
    Gender distribution was analysed only for the safety set.
    Units: Subjects
        Female
    		 48 48
        Male
    		 72 72
    Weight
    Weight at timepoint enrolment
    Units: kg
        arithmetic mean (standard deviation)
    		 78.9 ( 13.56 ) -
    Height
    Height at timepoint enrolment
    Units: cm
        arithmetic mean (standard deviation)
    		 177.0 ( 9.62 ) -
    Subject analysis sets

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received surgery with sequestrectomy for tissue harvest.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised who underwent surgery (sequestrectomy for SC patients; transplantation in case of NDplus or NDbasic patients) and with at least one primary efficacy assessment after surgery/implantation. This is equivalent to the ITT population.

    Subject analysis sets values
    		 Safety set Full analysis set
    Number of subjects
    120
    98
    Age categorical
    Patients aged 18 to 60 years
    Units: Subjects
        Adults aged 18 to 60 years
    120
    98
    Age continuous
    18 to 60 years
    Units: years
        arithmetic mean (standard deviation)
    41.7 ( 10.54 )
    ( )
    Gender categorical
    Gender distribution was analysed only for the safety set.
    Units: Subjects
        Female
    48
        Male
    72
    Weight
    Weight at timepoint enrolment
    Units: kg
        arithmetic mean (standard deviation)
    78.9 ( 13.56 )
    ( )
    Height
    Height at timepoint enrolment
    Units: cm
        arithmetic mean (standard deviation)
    177.0 ( 9.62 )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    NDplus
    Reporting group description
    		 Patients who receive NOVOCART Disc plus (acitve cells)

    Reporting group title
    NDbasic
    Reporting group description
    		 Patients who receive NOVOCART Basic (no active cells)

    Reporting group title
    Standard of Care (SC)
    Reporting group description
    		 Patients who received standard of care, sequestrectomy only.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received surgery with sequestrectomy for tissue harvest.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised who underwent surgery (sequestrectomy for SC patients; transplantation in case of NDplus or NDbasic patients) and with at least one primary efficacy assessment after surgery/implantation. This is equivalent to the ITT population.

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    To characerize the safe use of the IMP and the transplantation/implantation procedures. - Adverse events (AEs) by event category, intensity, seriousness, and relationship to the graft and/or procedure.
    End point type
    Primary
    End point timeframe
    Until the end of study.
    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: Results are only available as numbers and percentage of occurrence, no statistical analysis was done.
    End point values
    		 NDplus NDbasic Standard of Care (SC) Safety set
    Number of subjects analysed
    58
    37
    25
    120
    Units: Prevalence
    53
    31
    22
    120
    No statistical analyses for this end point

    Primary: Functional effects of NDplus over SC, 60 months FU

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    End point title
    		 Functional effects of NDplus over SC, 60 months FU [2]
    End point description
    ODI: Mean total score changes from baseline to 60 months.
    End point type
    Primary
    End point timeframe
    60 months after treatment
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses were done between NDplus arm versus SC arm and NDbasic arm versus SC. Therefore this endpoint is available twice (NDplus vs. SC, NDbasic vs. SC).
    End point values
    		 NDplus Standard of Care (SC)
    Number of subjects analysed
    41
    21
    Units: Oswestry Dissability Index (ODI)
    median (standard deviation)
        Changes from baseline
    -32.6 ( 21.69 )
    -34.6 ( 21.33 )
    Statistical analysis title
    		 ODI total score changes NDplus vs. SC 60 month FU
    Statistical analysis description
    Non-confirmatory study without pre-specified decision-making rules or hypotheses. NDplus vs. SC
    Comparison groups
    Standard of Care (SC) v NDplus
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.24 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 12.44
    Notes
    [3] - Non-confirmatory study without pre-specified decision-making rules or hypotheses. p-values for LS means NDplus vs. SC.
    [4] - NDplus vs. SC at 60 months follow-up

    Primary: Functional effects of NDplus over SC, 12 months follow-up

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    End point title
    		 Functional effects of NDplus over SC, 12 months follow-up [5]
    End point description
    ODI total score changes from 12 month follow-up to baseline (treatment).
    End point type
    Primary
    End point timeframe
    12 months after treatment
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses were done between NDplus arm versus SC arm and NDbasic arm versus SC. Therefore this endpoint is available twice (NDplus vs. SC, NDbasic vs. SC).
    End point values
    		 NDplus Standard of Care (SC)
    Number of subjects analysed
    46
    20
    Units: ODI total score changes from baseline
        arithmetic mean (standard deviation)
    -33.7 ( 19.91 )
    -33.8 ( 24.63 )
    Statistical analysis title
    		 ODI total score changes NDplus vs. SC 12 months FU
    Statistical analysis description
    ODI totgal score changes 12 months to baseline NDplus to SC
    Comparison groups
    NDplus v Standard of Care (SC)
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.3062
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 12.67
    Notes
    [6] - Non-confirmatory study without pre-specified decision-making rules or hypotheses.

    Primary: Functional effects of NDplus over SC, 24 months follow-up

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    End point title
    		 Functional effects of NDplus over SC, 24 months follow-up [7]
    End point description
    ODI total score changes from baseline to 12 months follow-up.
    End point type
    Primary
    End point timeframe
    12 months follow-up after treatment.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses were done between NDplus arm versus SC arm and NDbasic arm versus SC. Therefore this endpoint is available twice (NDplus vs. SC, NDbasic vs. SC).
    End point values
    		 NDplus Standard of Care (SC)
    Number of subjects analysed
    44
    22
    Units: ODI total score changes from baseline
        arithmetic mean (standard deviation)
    -32.4 ( 20.00 )
    -36.7 ( 22.46 )
    Statistical analysis title
    		 ODI total score changes NDplus 24 months FU
    Statistical analysis description
    Non-confirmatory study without pre-specified decision-making rules or hypotheses.
    Comparison groups
    Standard of Care (SC) v NDplus
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.0788
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.33
         upper limit
    		 16
    Notes
    [8] - Non-confirmatory study without pre-specified decision-making rules or hypotheses.

    Primary: Functional effects of NDbasic over SC, 24 months follow-up

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    End point title
    		 Functional effects of NDbasic over SC, 24 months follow-up [9]
    End point description
    End point type
    Primary
    End point timeframe
    24 months follow-up after treatment
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses were done between NDplus arm versus SC arm and NDbasic arm versus SC. Therefore this endpoint is available twice (NDplus vs. SC, NDbasic vs. SC).
    End point values
    		 NDbasic Standard of Care (SC)
    Number of subjects analysed
    26
    22
    Units: ODI total score changes from baseline
        arithmetic mean (standard deviation)
    -41.3 ( 19.22 )
    -36.7 ( 22.46 )
    Statistical analysis title
    		 ODI total score change NDbasic 24 months FU
    Statistical analysis description
    Non-confirmatory study without pre-specified decision-making rules or hypotheses.
    Comparison groups
    Standard of Care (SC) v NDbasic
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 = 0.4161
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18
         upper limit
    		 8
    Notes
    [10] - Non-confirmatory study without pre-specified decision-making rules or hypotheses.

    Primary: Functional effects of NDbasic over SC, 12 months follow-up

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    End point title
    		 Functional effects of NDbasic over SC, 12 months follow-up [11]
    End point description
    End point type
    Primary
    End point timeframe
    12 months follow-up after treatment
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses were done between NDplus arm versus SC arm and NDbasic arm versus SC. Therefore this endpoint is available twice (NDplus vs. SC, NDbasic vs. SC).
    End point values
    		 NDbasic Standard of Care (SC)
    Number of subjects analysed
    26
    20
    Units: ODI total score changes to baseline
        arithmetic mean (standard deviation)
    -39.6 ( 19.20 )
    -33.8 ( 24.63 )
    Statistical analysis title
    		 ODI total score changes NDbasic 12 months FU
    Comparison groups
    NDbasic v Standard of Care (SC)
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 = 0.1506
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20
         upper limit
    		 8
    Notes
    [12] - Non-confirmatory study without pre-specified decision-making rules or hypotheses.

    Primary: Functional effects of NDbasic over SC, 60 months FU

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    End point title
    		 Functional effects of NDbasic over SC, 60 months FU [13]
    End point description
    End point type
    Primary
    End point timeframe
    60 months follow-up after treatment
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses were done between NDplus arm versus SC arm and NDbasic arm versus SC. Therefore this endpoint is available twice (NDplus vs. SC, NDbasic vs. SC).
    End point values
    		 NDbasic Standard of Care (SC)
    Number of subjects analysed
    26
    21
    Units: ODI total score changes from baseline
        arithmetic mean (standard deviation)
    -39.1 ( 20.54 )
    -34.6 ( 21.33 )
    Statistical analysis title
    		 ODI total score changes NDbasic over SC 60 months
    Statistical analysis description
    ODI total score changes NBasic over SC at 60 months after treatment
    Comparison groups
    NDbasic v Standard of Care (SC)
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 = 0.9826
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18
         upper limit
    		 6.67
    Notes
    [14] - Non-confirmatory study without pre-specified decision-making rules or hypotheses.

    Secondary: MRI changes disc height NDplus, NDbasic, SC 60 months FU

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    End point title
    		 MRI changes disc height NDplus, NDbasic, SC 60 months FU
    End point description
    Caudal disc height (mm) (from volume) at timepoint 60 month after treatment.
    End point type
    Secondary
    End point timeframe
    Timepoint 60 months
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    18
    11
    6
    Units: Disc height
    arithmetic mean (standard deviation)
        Changes in total score ODI
    -0.5 ( 2.57 )
    2.1 ( 6.99 )
    0.1 ( 1.67 )
    No statistical analyses for this end point

    Secondary: MRI changes disc volume NDplus, NDbasic, SC 60 months FU

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    End point title
    		 MRI changes disc volume NDplus, NDbasic, SC 60 months FU
    End point description
    Caudal disc volume (mm3), changes from baseline to 60 months follow-up.
    End point type
    Secondary
    End point timeframe
    60 months follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    18
    11
    6
    Units: Caudal disc volume
        arithmetic mean (standard deviation)
    -488.6 ( 1378.36 )
    128.3 ( 2212.52 )
    -479.0 ( 711.81 )
    No statistical analyses for this end point

    Secondary: MRI changes signal intensity NDplus, NDbasic, SC 60 months FU

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    End point title
    		 MRI changes signal intensity NDplus, NDbasic, SC 60 months FU
    End point description
    Caudal disc T2 (ms) Relaxations time of MRI measured as signal intensity .
    End point type
    Secondary
    End point timeframe
    60 month follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    15
    13
    6
    Units: Signal intensity (T2 relaxation time)
        arithmetic mean (standard deviation)
    -6.5 ( 8.27 )
    -3.0 ( 11.82 )
    1.9 ( 13.55 )
    No statistical analyses for this end point

    Secondary: MRI changes disc height NDplus, NDbasic, SC 12 months FU

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    End point title
    		 MRI changes disc height NDplus, NDbasic, SC 12 months FU
    End point description
    Caudial disc height (mm) (from volume) at timepoint 12 months after treatment.
    End point type
    Secondary
    End point timeframe
    Timepoint 12 months follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    21
    12
    7
    Units: Disc height
        arithmetic mean (standard deviation)
    0.00 ( 2.01 )
    0.4 ( 0.98 )
    0.2 ( 0.90 )
    No statistical analyses for this end point

    Secondary: MRI changes disc height NDplus, NDbasic, SC 24 months FU

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    End point title
    		 MRI changes disc height NDplus, NDbasic, SC 24 months FU
    End point description
    Caudal disc height (mm) (from volume) at timepoint 24 months after treatment.
    End point type
    Secondary
    End point timeframe
    Timepoint 24 months follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    18
    12
    7
    Units: Disc height
        arithmetic mean (standard deviation)
    -0.2 ( 1.52 )
    0.6 ( 0.99 )
    1.0 ( 0.86 )
    No statistical analyses for this end point

    Secondary: MRI changes disc volume NDplus, NDbasic, SC 12 months FU

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    End point title
    		 MRI changes disc volume NDplus, NDbasic, SC 12 months FU
    End point description
    Caudal disc volume (mm3) at timepoint 12 months after treatment.
    End point type
    Secondary
    End point timeframe
    Timepoint 12 months follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    21
    12
    6
    Units: Disc volume
        arithmetic mean (standard deviation)
    169.9 ( 971.39 )
    319.9 ( 1336.64 )
    496.9 ( 1280.50 )
    No statistical analyses for this end point

    Secondary: MRI changes disc volume NDplus, NDbasic, SC 24 months FU

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    End point title
    		 MRI changes disc volume NDplus, NDbasic, SC 24 months FU
    End point description
    Caudal disc volume (mm3) at timepoint 24 months after treatment.
    End point type
    Secondary
    End point timeframe
    Timepoint 24 months follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    18
    12
    7
    Units: Disc volume
        arithmetic mean (standard deviation)
    -180.1 ( 1166.15 )
    1.8 ( 1689.02 )
    802.7 ( 1364.16 )
    No statistical analyses for this end point

    Secondary: MRI changes signal intensity NDplus, NDbasic, SC 12 months FU

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    End point title
    		 MRI changes signal intensity NDplus, NDbasic, SC 12 months FU
    End point description
    Caudal disc T2 (ms) at timepoint 12 months after treatment.
    End point type
    Secondary
    End point timeframe
    Timepoint 12 months follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    19
    12
    7
    Units: Disc signal intensity (T2 relaxation tim
        arithmetic mean (standard deviation)
    -1.6 ( 8.89 )
    0 ( 7.12 )
    2.9 ( 10.93 )
    No statistical analyses for this end point

    Secondary: MRI changes signal intensity NDplus, NDbasic, SC 24 months FU

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    End point title
    		 MRI changes signal intensity NDplus, NDbasic, SC 24 months FU
    End point description
    Caudal disc T2 (ms) at timepoint 24 months after treatment.
    End point type
    Secondary
    End point timeframe
    Timepoint 24 months follow-up
    End point values
    		 NDplus NDbasic Standard of Care (SC)
    Number of subjects analysed
    16
    13
    7
    Units: Disc signal intensity (2 relaxation time
        arithmetic mean (standard deviation)
    -3.3 ( 9.64 )
    -1.3 ( 7.04 )
    5.9 ( 15.42 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study start to study finish.
    Adverse event reporting additional description
    Reporting by investigator after becoming aware of it with reporting form.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    actual
    Reporting groups
    Reporting group title
    Any AE NDplus group
    Reporting group description
    		 All NDplus patients

    Reporting group title
    Any AE NDbasic
    Reporting group description
    		 All NDbasic patients

    Reporting group title
    Any AE SC patients
    Reporting group description
    		 All patients from SC group

    Serious adverse events
    		 Any AE NDplus group Any AE NDbasic Any AE SC patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    40 / 53 (75.47%)
    12 / 37 (32.43%)
    6 / 25 (24.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Foot fracture
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post laminectomy syndrome
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 37 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Diastolic dysfunction
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperaesthesia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersomnia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 37 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic generalised epilepsy
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Arrested labour
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical incompetence
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 37 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Renal colic
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Ureteric stenosis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    11 / 53 (20.75%)
    4 / 37 (10.81%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    7 / 11
    3 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Sacroiliac joint dysfunction
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon calcification
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 37 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Erysipelas
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Intervertebral discitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Pneumonia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 37 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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: 5%
    Non-serious adverse events
    		 Any AE NDplus group Any AE NDbasic Any AE SC patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 53 (41.51%)
    31 / 37 (83.78%)
    22 / 25 (88.00%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Skin laceration
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 37 (2.70%)
    2 / 25 (8.00%)
         occurrences all number
    2
    1
    2
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    12 / 53 (22.64%)
    6 / 37 (16.22%)
    6 / 25 (24.00%)
         occurrences all number
    12
    6
    6
    Headache
         subjects affected / exposed
    5 / 53 (9.43%)
    4 / 37 (10.81%)
    2 / 25 (8.00%)
         occurrences all number
    5
    4
    2
    Radiculopathy
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences all number
    3
    1
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences all number
    3
    1
    0
    Nausea
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 37 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    3
    0
    1
    Toothache
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 37 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    3
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    Gastrooesophageal reflux disiease
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 37 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 37 (2.70%)
    2 / 25 (8.00%)
         occurrences all number
    1
    1
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 37 (8.11%)
    2 / 25 (8.00%)
         occurrences all number
    4
    3
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    16 / 53 (30.19%)
    9 / 37 (24.32%)
    12 / 25 (48.00%)
         occurrences all number
    16
    9
    12
    Intervertebral disc protrusion
         subjects affected / exposed
    17 / 53 (32.08%)
    10 / 37 (27.03%)
    1 / 25 (4.00%)
         occurrences all number
    17
    10
    1
    Arthralgia
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 37 (8.11%)
    1 / 25 (4.00%)
         occurrences all number
    5
    3
    1
    Procedural pain
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 37 (10.81%)
    1 / 25 (4.00%)
         occurrences all number
    1
    4
    1
    Facet joint syndrome
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    2
    1
    Pain in extremity
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    2
    1
    Ligament sprain
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Meniscus injury
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences all number
    3
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    20 / 53 (37.74%)
    9 / 37 (24.32%)
    7 / 25 (28.00%)
         occurrences all number
    20
    9
    7
    Bacterial infection
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 37 (2.70%)
    3 / 25 (12.00%)
         occurrences all number
    1
    1
    3
    Influenza
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    2
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 53 (7.55%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    4
    0
    0
    Bronchitis
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    0

    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.
    Final Safety results and brief summary of efficacy are reported in this synoptic clinical study report due to the Sponsor's decision to permanently discontinue the NDplus and NDbasic development program.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27567635
    http://www.ncbi.nlm.nih.gov/pubmed/26920137
    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
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