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    Clinical Trial Results:
    Subarachnoid administration of autologous bone marrow stromal cells in incomplete spinal cord injury.

    Summary
    EudraCT number
    		 2011-005684-24
    Trial protocol
    		 ES  
    Global end of trial date
    09 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2023
    First version publication date
    19 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CME-LEM2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02165904
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro
    Sponsor organisation address
    C/ Joaquín Rodrigo, 2, Majadahonda (Madrid), Spain, 28222
    Public contact
    Site contact point , Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro, +34 91 1917760,
    Scientific contact
    Site contact point, Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro, +34 91 1917760,
    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
    06 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Analyze the possible clinical efficacy of the administration of autologous stromal cells from the bone marrow expanded "in vitro" in the treatment of spinal cord injury patients (SCI) chronically established and incomplete (ASIA B, C or D).
    Protection of trial subjects
    Previous to NC1 preparation, a sample of peripheral blood was retrieved from each patient for genomic studies in order to rule out chromosomal abnormalities that could discourage cell expansion.
    Background therapy
    		 Patients performed physical therapy exercises.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The planned duration of the clinical trial was 24 months. The duration of the recruitment phase was 12 months, and the duration of the follow-up period after treatment was 12 months.

    Pre-assignment
    Screening details
    		 After signing the Informed Consent Form, participants were tested to determine if they met all the inclusion criteria and none of the exclusion criteria.

    Pre-assignment period milestones
    Number of subjects started
    		 12
    Number of subjects completed
    		 10

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Default selection criteria: 2
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable. All the participants received the same treatment.

    Arms
    Arm title
    		 Arm 1
    Arm description
    		 Treatment arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    NC1
    Investigational medicinal product code
    Other name
    PEI number 12–141 (by the Spanish Agency of Medicament and Health Products)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Administration inside of the syrinx of four doses of 30 x 10^6 autologous expanded mesenchymal stromal cells, supported in autologous plasma, through a surgical approach to the spinal cord (months 1, 4, 7 and 10). Therefore each patient received a total of 120 x 10^6 mesenchymal stromal cells.

    Number of subjects in period 1 [1]
    		Arm 1
    Started
    10
    Completed
    10
    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: 12 patients were enrolled in the study, but 2 of them were screening failures and did not receive the study treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 10 10
    Age categorical
    Age ranged between 34 and 59 years.
    Units: Subjects
        Adults (18-64 years)
    		 10 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.90 ( 8.85 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 8 8
    American Spinal Injury Association Impairment Scale (ASIA) grade
    Units: Subjects
        ASIA B
    		 4 4
        ASIA C
    		 5 5
        ASIA D
    		 1 1
    Spinal cord injury (SCI) vertebral level
    Units: Subjects
        C3-C4
    		 1 1
        C5-C5
    		 1 1
        C5-C6
    		 3 3
        D2
    		 1 1
        D7-D8
    		 1 1
        L1
    		 2 2
        L1-L2
    		 1 1
    Time since Spinal cord injury (SCI)
    Units: Subjects
        2.43
    		 1 1
        3.60
    		 1 1
        6.00
    		 1 1
        8.17
    		 1 1
        13.06
    		 1 1
        14.31
    		 1 1
        17.76
    		 1 1
        20.90
    		 1 1
        21.32
    		 1 1
        34.59
    		 1 1
    Time from spinal cord injury to treatment
    Units: years
        arithmetic mean (standard deviation)
    		 14.21 ( 9.88 ) -

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Treatment arm

    Subject analysis set title
    Before treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Baseline characteristics of the subjects

    Subject analysis set title
    At 3 months follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Characteristics of the subjects at 3 months follow-up

    Subject analysis set title
    At 6 months follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Characteristics of the subjects at 6 months follow-up

    Subject analysis set title
    At 9 months follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Characteristics of the subjects at 9 months follow-up

    Subject analysis set title
    At 12 months follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Characteristics of the subjects at 12 months follow-up

    Subject analysis set title
    At 4 months follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Characteristics of the subjects at 4 months follow-up

    Subject analysis set title
    At 7 months follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Characteristics of the subjects at 7 months follow-up

    Subject analysis set title
    At 10 months follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Characteristics of the subjects at 10 months follow-up

    Primary: Change in the score in ASIA scale

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    End point title
    		 Change in the score in ASIA scale
    End point description
    ASIA scale was used for sensitivity and motor assessments. Efficacy was assessed by taking into account the variation in the scores in the different scales between the subject's inclusion in the study and the scores obtained at the end of the follow-up period. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation.
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score
    arithmetic mean (standard deviation)
        Total Score
    188.2 ( 60 )
    202.2 ( 63.7 )
    218.4 ( 57.5 )
    228.9 ( 51.84 )
    235.5 ( 49.35 )
        Pin Prick Score
    54.50 ( 34.36 )
    61.20 ( 37.42 )
    71.60 ( 31.96 )
    78.30 ( 27.33 )
    82.80 ( 24.69 )
        Light Touch Score
    80.70 ( 11.70 )
    85.40 ( 14.08 )
    89.10 ( 13.19 )
    92.00 ( 13.26 )
    93.50 ( 12.89 )
        Motor Score
    53.00 ( 20.45 )
    55.60 ( 21.45 )
    57.70 ( 21.15 )
    58.60 ( 20.83 )
    59.20 ( 21.15 )
    Statistical analysis title
    		 Total Score: before treatment vs at 3 months FU
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Total Score: before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Total Score: before treatment vs at 9 months FU
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Total Score: before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 PinPrick Score: before treatment vs at 3 months FU
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.028
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 PinPrick Score: before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 PinPrick Score: before treatment vs at 9 months FU
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 PinPrick Score: before treatment vs at 12 months
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Light Touch Score: before treatment vs at 3 months
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Light Touch Score: before treatment vs at 6 months
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Light Touch Score: before treatment vs at 9 months
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Light Touch Score: before treatment vs 12 months
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Motor Score: before treatment vs at 3 months FU
    Comparison groups
    At 3 months follow-up v Before treatment
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.028
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Motor Score: before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Motor Score: before treatment vs at 9 months FU
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Motor Score: before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in the score in NIF scale

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    End point title
    		 Change in the score in NIF scale
    End point description
    Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment. Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence.
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on a scale
        arithmetic mean (standard deviation)
    95.7 ( 33.9 )
    95.7 ( 33.9 )
    95.7 ( 33.9 )
    96.10 ( 33.42 )
    98.6 ( 32.05 )
    Statistical analysis title
    		 Before treatment v At 3 months follow-up
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 9 months follow-up
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.157
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.027
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in the score in BARTHEL Scale

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    End point title
    		 Change in the score in BARTHEL Scale
    End point description
    Changes in Barthel score at the beginning, through and the end of the treatment. Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence.
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on a scale
        arithmetic mean (standard deviation)
    58 ( 36.07 )
    58 ( 36.07 )
    58 ( 36.07 )
    58 ( 36.07 )
    65 ( 35.59 )
    Statistical analysis title
    		 Before treatment v At 3 months follow-up
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 9 months follow-up
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.039
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in the score in IANR-SCIFRS scale

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    End point title
    		 Change in the score in IANR-SCIFRS scale
    End point description
    Changes in IANC-SCIFRS scale. The SCI Functional Rating Scale of the International Association of Neurorestoratology scale. This scale evaluates the global spinal cord function through nine sections, with a final section that only applies to men and assesses sexual function. Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value.
    End point type
    Primary
    End point timeframe
    Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Global
    29.10 ( 9.96 )
    31.5 ( 8.9 )
    33.9 ( 9.73 )
    35.9 ( 9.01 )
    36.9 ( 8.21 )
        Sexual (male)
    1.88 ( 0.64 )
    1.88 ( 0.64 )
    2.13 ( 0.64 )
    2.13 ( 0.64 )
    2.13 ( 0.64 )
    Statistical analysis title
    		 Global: Before treatment v At 3 months follow-up
    Comparison groups
    At 3 months follow-up v Before treatment
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.017
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Global: Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Global: Before treatment v At 9 months follow-up
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Global: Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Sexual Score (M): before treatment vs at 3 months
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Sexual Score (M): before treatment vs at 6 months
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.157
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Sexual Score (M): before treatment vs at 9 months
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.157
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Sexual Score (M): before treatment vs at 12 months
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.157
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in the score in PENN scale

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    End point title
    		 Change in the score in PENN scale
    End point description
    PENN scale measures the degree of spasms. Changes in PENN score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour.
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on a scale
        arithmetic mean (standard deviation)
    1.20 ( 1.14 )
    1.10 ( 1.10 )
    0.90 ( 0.88 )
    0.90 ( 0.88 )
    0.90 ( 0.88 )
    Statistical analysis title
    		 Before treatment v At 3 months follow-up
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.317
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.18
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 9 months follow-up
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.18
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.18
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in the score in Ashworth scale

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    End point title
    		 Change in the score in Ashworth scale
    End point description
    Ashworth scale measures the degree of spasticity. Efficacy was assessed by taking into account the variation in ASHWORTH score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 when there isn't increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on scale
        arithmetic mean (standard deviation)
    1.4 ( 0.81 )
    1.4 ( 0.81 )
    1.4 ( 0.81 )
    1.4 ( 0.81 )
    1.10 ( 0.99 )
    Statistical analysis title
    		 before treatment vs at 3 months FU
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 9 months FU
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.157
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in score in VAS scale

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    End point title
    		 Change in score in VAS scale
    End point description
    VAS: Visual Analog Scale. This scale evaluates neuropathic pain. Changes in VAS score at the beginning, through and the end of the treatment Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain.
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on a scale
        arithmetic mean (standard deviation)
    1.70 ( 3.13 )
    0.70 ( 1.16 )
    0.60 ( 0.97 )
    0.40 ( 0.84 )
    0.40 ( 0.84 )
    Statistical analysis title
    		 before treatment vs at 3 months FU
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.109
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.109
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 9 months FU
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.109
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.109
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in score in GEFFNER scale

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    End point title
    		 Change in score in GEFFNER scale
    End point description
    Geffner scale was used for the study of bladder function. Efficacy was assessed by taking into account the variation in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder
    End point type
    Primary
    End point timeframe
    Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on scale
        arithmetic mean (standard deviation)
    3.30 ( 1.34 )
    3.60 ( 1.26 )
    3.80 ( 1.14 )
    3.90 ( 1.10 )
    4.20 ( 1.23 )
    Statistical analysis title
    		 Before treatment v At 3 months follow-up
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.18
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    At 6 months follow-up v Before treatment
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.102
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 9 months follow-up
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.063
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.024
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in score in NBD scale

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    End point title
    		 Change in score in NBD scale
    End point description
    NBD scale was used for the study of of neurogenic bowel dysfunction (NBD). Efficacy was assessed by taking into account the variation in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction.
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
    End point values
    		 Before treatment At 3 months follow-up At 6 months follow-up At 9 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    10
    10
    Units: Score on a scale
        arithmetic mean (standard deviation)
    10.60 ( 6.64 )
    6.10 ( 4.15 )
    5.70 ( 4.35 )
    4.40 ( 3.86 )
    4.20 ( 3.88 )
    Statistical analysis title
    		 Before treatment v At 3 months follow-up
    Comparison groups
    Before treatment v At 3 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.042
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.018
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 9 months follow-up
    Comparison groups
    Before treatment v At 9 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.018
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.018
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in urodynamic studies: detrusor pressure

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    End point title
    		 Change in urodynamic studies: detrusor pressure
    End point description
    Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)
    End point type
    Primary
    End point timeframe
    Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up)
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: cm/H2O
        arithmetic mean (standard deviation)
    68.6 ( 20.08 )
    53.8 ( 20.8 )
    51.5 ( 37.22 )
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.074
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.169
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in urodynamic studies: Bladder compliance

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    End point title
    		 Change in urodynamic studies: Bladder compliance
    End point description
    Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling. It gives an indication on how the different mechanisms in the bladder wall react on stretching. It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality.
    End point type
    Primary
    End point timeframe
    Measure before treatment (baseline visit), 6 and 12 months after surgery
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: mL/cm H2O
        arithmetic mean (standard deviation)
    3.88 ( 3.24 )
    6.14 ( 3.36 )
    8.28 ( 6.41 )
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.059
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.037
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in urodynamic studies: Maximum cystometric capacity

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    End point title
    		 Change in urodynamic studies: Maximum cystometric capacity
    End point description
    Urodynamic studies in terms of Maximum cystometric capacity
    End point type
    Primary
    End point timeframe
    Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: mL
        arithmetic mean (standard deviation)
    234.9 ( 156.26 )
    292.4 ( 110.93 )
    292.6 ( 183.6 )
    Statistical analysis title
    		 Before treatment v At 6 months follow-up
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.202
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Before treatment v At 12 months follow-up
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.646
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in neurophysiological parameters: improvement in Somatosensory Evoked Potentials (SSEP)

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    End point title
    		 Change in neurophysiological parameters: improvement in Somatosensory Evoked Potentials (SSEP)
    End point description
    Change in neurophysiological parameters: improvement in Somatosensory Evoked Potentials (SSEP)
    End point type
    Primary
    End point timeframe
    Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: Number of patients
        Improvement in SSEP
    0
    7
    8
        No improvement in SSEP
    10
    3
    2
    Statistical analysis title
    		 Before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.206
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.058
    Method
    		 Chi-squared
    Confidence interval

    Primary: Change in neurophysiological parameters: improvement in Motor Evoked Potentials (MEP)

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    End point title
    		 Change in neurophysiological parameters: improvement in Motor Evoked Potentials (MEP)
    End point description
    Change in neurophysiological parameters: improvement in Motor Evoked Potentials (MEP)
    End point type
    Primary
    End point timeframe
    Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: Number of patients
        Improvement in MEP
    0
    4
    5
        No improvement in MEP
    10
    6
    5
    Statistical analysis title
    		 Before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Primary: Change in neurophysiological parameters: improvement in sensitivity conduction

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    End point title
    		 Change in neurophysiological parameters: improvement in sensitivity conduction
    End point description
    Change in neurophysiological parameters: improvement in sensitivity conduction
    End point type
    Primary
    End point timeframe
    Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: Number of patients
        Improvement
    0
    2
    3
        No improvement
    10
    8
    7
    Statistical analysis title
    		 Before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.058
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.206
    Method
    		 Chi-squared
    Confidence interval

    Primary: Change in neurophysiological parameters: improvement in motor conduction

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    End point title
    		 Change in neurophysiological parameters: improvement in motor conduction
    End point description
    Change in neurophysiological parameters: improvement in motor conduction
    End point type
    Primary
    End point timeframe
    Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: Number of patients
        Improvement
    0
    5
    7
        No improvement
    10
    5
    3
    Statistical analysis title
    		 Before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.206
    Method
    		 Chi-squared
    Confidence interval

    Primary: Change in neurophysiological parameters: improvement in voluntary muscle contraction

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    End point title
    		 Change in neurophysiological parameters: improvement in voluntary muscle contraction
    End point description
    Change in neurophysiological parameters: improvement in voluntary muscle contraction
    End point type
    Primary
    End point timeframe
    Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: Number of patients
        Improvement
    0
    4
    6
        No improvement
    10
    6
    4
    Statistical analysis title
    		 Before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4
    Method
    		 Chi-squared
    Confidence interval

    Primary: Change in neurophysiological parameters: presence of infralesional activity muscle reinnervation

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    End point title
    		 Change in neurophysiological parameters: presence of infralesional activity muscle reinnervation
    End point description
    Change in neurophysiological parameters: presence of infralesional activity muscle reinnervation
    End point type
    Primary
    End point timeframe
    Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
    End point values
    		 Before treatment At 6 months follow-up At 12 months follow-up
    Number of subjects analysed
    10
    10
    10
    Units: Number of patients
        Improvement
    0
    7
    9
        No improvement
    10
    3
    1
    Statistical analysis title
    		 Before treatment vs at 6 months FU
    Comparison groups
    Before treatment v At 6 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.206
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Before treatment vs at 12 months FU
    Comparison groups
    Before treatment v At 12 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.011
    Method
    		 Chi-squared
    Confidence interval

    Primary: Modification of magnetic resonance imaging (MRI)

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    End point title
    		 Modification of magnetic resonance imaging (MRI) [1]
    End point description
    Number of patients with changes in morphology of injury compared with basal images.
    End point type
    Primary
    End point timeframe
    Before treatment (baseline visit) and at 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: A qualitative evaluation was performed, comparing the results at month 12 with the baseline values.
    End point values
    		 Before treatment At 12 months follow-up
    Number of subjects analysed
    10
    10
    Units: Number of patients
        Morphological changes
    0
    0
        No morphological changes
    10
    10
    No statistical analyses for this end point

    Secondary: Change in expression of neurotrophins (BDNF) in CSF (cerebrospinal fluid) samples

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    End point title
    		 Change in expression of neurotrophins (BDNF) in CSF (cerebrospinal fluid) samples
    End point description
    Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophin was: BDNF (brain-derived neurotrophic factor).
    End point type
    Secondary
    End point timeframe
    Basal and 10 months after the administration
    End point values
    		 Before treatment At 10 months follow-up
    Number of subjects analysed
    9 [2]
    9 [3]
    Units: pg/ml
        arithmetic mean (standard deviation)
    19.14 ( 4.58 )
    33.82 ( 49.65 )
    Notes
    [2] - This data was not obtained in one of the patients.
    [3] - This data was not obtained in one of the patients.
    Statistical analysis title
    		 before treatment vs at 10 months FU
    Comparison groups
    Before treatment v At 10 months follow-up
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.515
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in expression of neurotrophins (GDNF) in CSF (cerebrospinal fluid) samples

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    End point title
    		 Change in expression of neurotrophins (GDNF) in CSF (cerebrospinal fluid) samples
    End point description
    Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophin was: GDNF (glial cell line-derived neurotrophic factor).
    End point type
    Secondary
    End point timeframe
    Basal, 4, 7 and 10 months after the administration
    End point values
    		 Before treatment At 4 months follow-up At 7 months follow-up At 10 months follow-up
    Number of subjects analysed
    10
    10
    8 [4]
    10
    Units: pg/ml
        arithmetic mean (standard deviation)
    10.20 ( 1.96 )
    10.93 ( 2.37 )
    11.31 ( 1.57 )
    10.46 ( 2.79 )
    Notes
    [4] - This data was not obtained in two patients.
    Statistical analysis title
    		 before treatment vs at 4 months FU
    Comparison groups
    Before treatment v At 4 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.262
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 7 months FU
    Comparison groups
    Before treatment v At 7 months follow-up
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.398
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 10 months FU
    Comparison groups
    Before treatment v At 10 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.766
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in expression of neurotrophins (NGF) in CSF (cerebrospinal fluid) samples

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    End point title
    		 Change in expression of neurotrophins (NGF) in CSF (cerebrospinal fluid) samples
    End point description
    Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophin was: NGF (nerve growth factor).
    End point type
    Secondary
    End point timeframe
    Basal 4, 7 and 10 months after the administration
    End point values
    		 Before treatment At 4 months follow-up At 7 months follow-up At 10 months follow-up
    Number of subjects analysed
    10
    10
    8 [5]
    10
    Units: pg/ml
        arithmetic mean (standard deviation)
    98.34 ( 19.34 )
    98.26 ( 17.30 )
    92.79 ( 12.01 )
    92.42 ( 14.84 )
    Notes
    [5] - This data was not obtained in two patients.
    Statistical analysis title
    		 before treatment vs at 4 months FU
    Comparison groups
    Before treatment v At 4 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.508
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 7 months FU
    Comparison groups
    Before treatment v At 7 months follow-up
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.123
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 10 months FU
    Comparison groups
    Before treatment v At 10 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.575
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in expression of neurotrophins (CNTF) in CSF (cerebrospinal fluid) samples

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    End point title
    		 Change in expression of neurotrophins (CNTF) in CSF (cerebrospinal fluid) samples
    End point description
    Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophin was: CNTF (Ciliary neurotrophic factor).
    End point type
    Secondary
    End point timeframe
    Basal 4,7 and 10 months after the administration
    End point values
    		 Before treatment At 4 months follow-up At 7 months follow-up At 10 months follow-up
    Number of subjects analysed
    10
    10
    9 [6]
    9 [7]
    Units: pg/ml
        arithmetic mean (standard deviation)
    5.82 ( 3.47 )
    6.66 ( 4.55 )
    8.76 ( 5.21 )
    7.73 ( 4.82 )
    Notes
    [6] - This data was not obtained in one of the patients.
    [7] - This data was not obtained in one of the patients.
    Statistical analysis title
    		 before treatment vs at 4 months FU
    Comparison groups
    Before treatment v At 4 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.241
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 7 months FU
    Comparison groups
    Before treatment v At 7 months follow-up
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.011
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 10 months FU
    Comparison groups
    Before treatment v At 10 months follow-up
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.066
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in expression of neurotrophins (NT3) in CSF (cerebrospinal fluid) samples

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    End point title
    		 Change in expression of neurotrophins (NT3) in CSF (cerebrospinal fluid) samples
    End point description
    Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophin was: NT3 (neurotrophin-3).
    End point type
    Secondary
    End point timeframe
    Basal, 4, 7 and 10 months after the administration
    End point values
    		 Before treatment At 4 months follow-up At 7 months follow-up At 10 months follow-up
    Number of subjects analysed
    10
    10
    8 [8]
    10
    Units: pg/ml
        arithmetic mean (standard deviation)
    175.00 ( 53.39 )
    205.66 ( 35.20 )
    213.04 ( 77.44 )
    188.00 ( 50.59 )
    Notes
    [8] - This data was not obtained in two patients.
    Statistical analysis title
    		 before treatment vs at 4 months FU
    Comparison groups
    Before treatment v At 4 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.114
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 7 months FU
    Comparison groups
    Before treatment v At 7 months follow-up
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.401
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 10 months FU
    Comparison groups
    Before treatment v At 10 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.508
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in expression of neurotrophins (NT4) in CSF (cerebrospinal fluid) samples

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    End point title
    		 Change in expression of neurotrophins (NT4) in CSF (cerebrospinal fluid) samples
    End point description
    Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophin was: NT4 (neurotrophin-4).
    End point type
    Secondary
    End point timeframe
    Basal, 4, 7 and 10 months after the administration
    End point values
    		 Before treatment At 4 months follow-up At 7 months follow-up At 10 months follow-up
    Number of subjects analysed
    10
    10
    8 [9]
    10
    Units: pg/ml
        arithmetic mean (standard deviation)
    3.72 ( 0.87 )
    3.40 ( 0.57 )
    3.85 ( 0.73 )
    4.07 ( 1.50 )
    Notes
    [9] - This data was not obtained in two patients.
    Statistical analysis title
    		 before treatment vs at 4 months FU
    Comparison groups
    Before treatment v At 4 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.445
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 7 months FU
    Comparison groups
    Before treatment v At 7 months follow-up
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.889
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 before treatment vs at 10 months FU
    Comparison groups
    Before treatment v At 10 months follow-up
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.441
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the entire clinical trial (Up to 12 months)
    Adverse event reporting additional description
    Adverse events were collected asking questions to the participants and performing general clinical examinations and neurological examinations.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Treatment arm

    Serious adverse events
    		 Arm 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Arm 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 10 (90.00%)
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 10 (30.00%)
         occurrences all number
    4
    Syncope
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Pain in coccyx
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Local pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Hyperthermia
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Leg pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Infected skin ulcer
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Nasopharingytis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2015
    Incorporation of the Geffner and NBD scales as efficacy variables. Addition of non-harmful events classification.

    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.
    The main limitation of the study is the small number of subjects analysed

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28089079
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