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    Clinical Trial Results:
    Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a single arm, open label, interventional, follow-up study

    Summary
    EudraCT number
    		 2021-005399-21
    Trial protocol
    		 AT  
    Global end of trial date
    03 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Dec 2025
    First version publication date
    27 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IC-01-02-2-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Innovacell GmbH
    Sponsor organisation address
    Mitterweg 24, Innsbruck, Austria, 6020
    Public contact
    Innovacell GmbH, Innovacell GmbH, 0043 512573680, office@innovacell.com
    Scientific contact
    Innovacell GmbH, Innovacell GmbH, 0043 512573680, office@innovacell.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of safety and efficacy of study treatment
    Protection of trial subjects
    This study was conducted in full accordance with the International Conference of Harmonisation Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    16 Oct 2023
    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
    Austria: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    3
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Approximately 10 patients that were planned to be randomized to placebo in STEFFI study (EudraCT 2010-021463-32). Patient recruitment was completed within 1 month. Patients have

    Pre-assignment
    Screening details
    		 Eligible patients were identified from the placebo group of the preceding STEFFI study and invited to participate in this follow-up. After signing a new informed consent, patients underwent baseline assessments, received ICEF15 treatment, and attended predefined follow-up visits to evaluate efficacy and safety.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Arm title
    		 Treatment Arm
    Arm description
    		 All patients enrolled in the STEFFI-FU study received treatment with ICEF15, and aSMDC product. The IMP was administered as a single intramuscular injection of 50 ± 10 x 106 cells into the external anal sphincter at the treatment/implantation visit
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous skeletal muscle-derived cells
    Investigational medicinal product code
    ICEF15
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The IMP (50+/- 10 x 10e6 aSMDC) is stored and transported in 3 x 1 mL cell transportation medium. Each dose of IMP is filled in 3 cryovials. Prior to implantation, IMP is prepared and thawed by addition of 3 x 1 mL Ringer's lactate solution. Total volume of IMP injected for implantation of 6 mL. The IMP was injected (single administration) at Visit 3 into the external anal sphincter of each of each patient using standardized, ultrasound -guided injection tool under analgo sedation (or general anaesthesia, if preferred).

    Number of subjects in period 1
    		Treatment Arm
    Started
    7
    Completed
    7

    Baseline characteristics

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

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 7 7
    Age categorical
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.9 ( 17.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 All patients enrolled in the STEFFI-FU study received treatment with ICEF15, and aSMDC product. The IMP was administered as a single intramuscular injection of 50 ± 10 x 106 cells into the external anal sphincter at the treatment/implantation visit

    Primary: Absolute change IEF 3 months

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    End point title
    		 Absolute change IEF 3 months [1]
    End point description
    The frequency of incontinence episodes were documented by a bowel diary that was completed by the patient. In this study, the frequency of incontinence episodes was calculated as the number of incontinence episodes over a period of 2 weeks.
    End point type
    Primary
    End point timeframe
    The primary endpoint of the current study was the incontinence episode frequency at V5 (3 months post implantation) compared to V2 (baseline period).
    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: Due to the limited number of patients included no formal testing has been applied
    End point values
    		 Treatment Arm
    Number of subjects analysed
    7
    Units: IEF change
        arithmetic mean (standard deviation)
    3.25 ( 0.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe of reporting adverse event: 16-OCT-2023 to 03-APR-2024
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 All patients enrolled in the STEFFI-FU study received treatment with ICEF15, and aSMDC product. The IMP was administered as a single intramuscular injection of 50 ± 10 x 106 cells into the external anal sphincter at the treatment/implantation visit

    Serious adverse events
    		 Treatment Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 Treatment Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
    Cardiac disorders
    Palpitations
    Additional description: Possibly related to concomitant Pelvic Floor Electrical Stimulation
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
    Additional description: Related to IMP - the AE has been reported for 2 patients
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Gastrointestinal disorders
    Rectal spasm
    Additional description: Related to concomitant Pelvic Floor Electrical Stimulation
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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