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    Clinical Trial Results:
    Highdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosis Modification according to manifestation

    Summary
    EudraCT number
    		 2011-002434-40
    Trial protocol
    		 DE  
    Global end of trial date
    27 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2025
    First version publication date
    01 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AST-MOMA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University hospital Tuebingen
    Sponsor organisation address
    Hoppe-Seyler-Straße 3, Tübingen, Germany, 72076
    Public contact
    Department Internal Medicine II, University Hospital Tuebinegn, 0049 70712980681, joerg.henes@med.uni-tuebingen.de
    Scientific contact
    Department Internal Medicine II, University Hospital Tuebinegn, 0049 70712980681, joerg.henes@med.uni-tuebingen.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
    02 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To optimise the treatment for severe systemic sclerosis with high dose chemotherapy and autologous stem cell transplantation by adapting the procedure to the individual organ manifestation.
    Protection of trial subjects
    The procedures set out in this trial protocol, pertaining to the conduct, evaluation, and documentation of this trial, are designed to ensure that all persons involved in the trial act according to Good Clinical Practice (GCP) and the ethical principles described in the applicable version of the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 44 patients were included, during screening 9 patients were excluded, 35 patients were transplanted

    Pre-assignment
    Screening details
    		 Patienten mit Cyclophosphamid refraktärer systemischer Sklerose mit schwerer Organbeteiligung

    Pre-assignment period milestones
    Number of subjects started
    		 44
    Number of subjects completed
    		 44

    Period 1
    Period 1 title
    aHSCT (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    n.a

    Arms
    Arm title
    		 Investigational arm
    Arm description
    		 single arm design
    Arm type
    		 Experimental

    Investigational medicinal product name
    HSCT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infusion
    Dosage and administration details
    n.a

    Number of subjects in period 1
    		Investigational arm
    Started
    44
    Completed
    44

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Investigational arm
    Reporting group description
    		 single arm design

    Primary: Overall survival 3 years

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    End point title
    		 Overall survival 3 years [1]
    End point description
    End point type
    Primary
    End point timeframe
    3 years
    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: Statistical details and charts can be found in the scientific publication: https://ard.bmj.com/content/83/Suppl_1/175.1
    End point values
    		 Investigational arm
    Number of subjects analysed
    44
    Units: Percentage
    44
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Every adverse event must be documented within 36 months after transplantation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Deatils of Adverse events can be found in the scientific publiciation: https://ard.bmj.com/content/83/Suppl_1/175.1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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
    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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