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    Clinical Trial Results:
    Treatment of autologous mesenchymal stem cells derived from bone marrow as a potential therapeutic strategy for the treatment of multiple sclerosis

    Summary
    EudraCT number
    		 2012-000734-19
    Trial protocol
    		 ES  
    Global end of trial date
    27 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Apr 2022
    First version publication date
    21 Apr 2022
    Other versions
    Summary report(s)
    		 Treatment of autologous mesenchymal stem cells derived from bone marrow as a potential therapeutic strategy for the treatment of multiple sclerosis

    Trial information

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    Trial identification
    Sponsor protocol code
    XCEL-MS-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Banc de Sang i Teixits
    Sponsor organisation address
    Passeig Taulat 116, Barcelona, Spain,
    Public contact
    Ruth Coll, Banc de Sang i Teixits, 34 93557 35 00, rucoll@bst.cat
    Scientific contact
    Ruth Coll, Banc de Sang i Teixits, 34 93557 35 00, rucoll@bst.cat
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1 - To evaluate the safety and tolerability of XCEL-MC-ALPHA by: a. Overall incidence of adverse events by treatment b. Incidence of adverse events by organ system preferred term, by treatment. c. Severity of adverse events per treatment. d. Intensity of adverse events per treatment. e. Causation by treatment.
    Protection of trial subjects
    There were no specific procedure. BM extraction were performed under local anaesthesia and sedation, and were discharged few hours later.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment period was from May 11th, 2015 to August 23trd, 2016. All patients were included in a single center (Hospital Vall d'Hebron) in Barcelona.

    Pre-assignment
    Screening details
    		 All screened patients (8) were compliant with inclusion/exclusion details and all entered the trial. All patients were diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS).

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 XCEL-MC-ALPHA/Placebo
    Arm description
    		 Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved in saline solution balanced with electrolytes (ViafloPlasmalyte, Baxter, S.L) and 2% v/v of human serum albumin (Instituto Grifols, S.A. Suspension for injection)]. Dose: 106±20% cells/kg. Mode of administration: Intravenous use. Infusion duration: 10 minutes
    Arm type
    		 Experimental

    Investigational medicinal product name
    XCEL-MC-ALPHA
    Investigational medicinal product code
    Other name
    BM-MSC cryopreserved
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Dose: 106±20% cells/kg (0.8x106 to 1.2x106 cells/kg). Mode of administration: Intravenous use. Infusion duration: 10 minutes.

    Arm title
    		 Placebo/XCEL-MC-ALPHA
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Dose: NA. Mode of administration: Intravenous use. Infusion duration: 10 minutes.

    Number of subjects in period 1
    		XCEL-MC-ALPHA/Placebo Placebo/XCEL-MC-ALPHA
    Started
    4
    4
    Completed
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 8 8
    Age categorical
    Demography and Baseline Characteristics: Mean (SD) age = 43.3 (5.6), 50% men, mean (SD) of years since the first outbreak = 15.7 (8.3), mean (SD) of outbreaks in the last year = 1.0 (0.5) and mean (SD) of baseline EDSS score = 3.0 (0.7). No significant differences were observed on demography and baseline characteristics, medical history and concurrent illnesses between the two groups at randomisation (U Mann-Whitney test, p>0.05 and Fisher’s exact test, p>0.05).
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all eligible patients who have received the study treatment.

    Subject analysis set title
    Efficacy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients in the safety population who have not incurred in any major protocol violation and have at least one baseline and one subsequent primary efficacy endpoint assessment of each treatment period. It will be the reference population for the efficacy analyses.

    Subject analysis sets values
    		 Safety Efficacy
    Number of subjects
    8
    8
    Age categorical
    Demography and Baseline Characteristics: Mean (SD) age = 43.3 (5.6), 50% men, mean (SD) of years since the first outbreak = 15.7 (8.3), mean (SD) of outbreaks in the last year = 1.0 (0.5) and mean (SD) of baseline EDSS score = 3.0 (0.7). No significant differences were observed on demography and baseline characteristics, medical history and concurrent illnesses between the two groups at randomisation (U Mann-Whitney test, p>0.05 and Fisher’s exact test, p>0.05).
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    8
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    XCEL-MC-ALPHA/Placebo
    Reporting group description
    		 Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved in saline solution balanced with electrolytes (ViafloPlasmalyte, Baxter, S.L) and 2% v/v of human serum albumin (Instituto Grifols, S.A. Suspension for injection)]. Dose: 106±20% cells/kg. Mode of administration: Intravenous use. Infusion duration: 10 minutes

    Reporting group title
    Placebo/XCEL-MC-ALPHA
    Reporting group description
    		 -

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all eligible patients who have received the study treatment.

    Subject analysis set title
    Efficacy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients in the safety population who have not incurred in any major protocol violation and have at least one baseline and one subsequent primary efficacy endpoint assessment of each treatment period. It will be the reference population for the efficacy analyses.

    Primary: Safety

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    End point title
    		 Safety
    End point description
    The safety and tolerability were evaluated by: a. Overall incidence of adverse events by treatment. b. Incidence of adverse events by system organ class and preferred term, by treatment. c. Severity of adverse events per treatment. d. Intensity of adverse events per treatment. e. Causatlity assessment.
    End point type
    Primary
    End point timeframe
    Week 24 and week 48
    End point values
    		 XCEL-MC-ALPHA/Placebo Placebo/XCEL-MC-ALPHA Safety
    Number of subjects analysed
    4
    4
    8
    Units: number
    4
    4
    8
    Statistical analysis title
    		 Descriptive
    Statistical analysis description
    Descriptive statistics: • Categorical variables: frequencies and category percentages. • Continuous variables: Mean and Standard Deviation (SD); Median and 25th and 75th percentiles of the distribution; number of cases; minimum and maximum value.
    Comparison groups
    Placebo/XCEL-MC-ALPHA v XCEL-MC-ALPHA/Placebo
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - Descriptive

    Secondary: Efficacy: Lesions that enhance with gadolinium T1 in sequence MRI

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    End point title
    		 Efficacy: Lesions that enhance with gadolinium T1 in sequence MRI
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 XCEL-MC-ALPHA/Placebo Placebo/XCEL-MC-ALPHA Efficacy
    Number of subjects analysed
    4
    4
    8
    Units: number
    4
    4
    8
    Statistical analysis title
    		 Enhanced lesions with gadolinium T1
    Comparison groups
    XCEL-MC-ALPHA/Placebo v Placebo/XCEL-MC-ALPHA
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 24
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    XCEL-MC-ALPHA/Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo/XCEL-MC-ALPHA
    Reporting group description
    		 -

    Serious adverse events
    		 XCEL-MC-ALPHA/Placebo Placebo/XCEL-MC-ALPHA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 XCEL-MC-ALPHA/Placebo Placebo/XCEL-MC-ALPHA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Neuralgia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Otitis externa
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Excessive cerumen production
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Vertigo
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 4 (50.00%)
         occurrences all number
    1
    2
    Periodontitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    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.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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