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    Summary
    EudraCT Number:2021-001376-42
    Sponsor's Protocol Code Number:IC-01-02-5-009
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2021-001376-42
    A.3Full title of the trial
    Skeletal muscle-derived cell implantation for the treatment of fecal
    incontinence: a phase III, randomized, controlled, double blind, two armed
    clinical study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial comparing muscle cell treatment with placebo in fecal
    incontinence patients
    A.3.2Name or abbreviated title of the trial where available
    FI-3 Fidelia
    A.4.1Sponsor's protocol code numberIC-01-02-5-009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04976153
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInnovacell GmbH
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInnovacell GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInnovacell GmbH
    B.5.2Functional name of contact pointInnovacell GmbH
    B.5.3 Address:
    B.5.3.1Street AddressScience Park Innsbruck Mitterweg 24
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.6E-mailoffice@innovacell.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameautologous Skeletal Muscle Derived Cells (aSMDC)
    D.3.2Product code ICEF15
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    Intramuscular use
    Rectal use
    Transdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.3Other descriptive nameAutologous skeletal myoblasts, ex vivo expanded
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40000000 to 60000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberEMEA/CAT/674819/2009
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fecal incontinence
    E.1.1.1Medical condition in easily understood language
    Accidental bowel leakage
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016296
    E.1.2Term Fecal incontinence
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055507
    E.1.2Term Fecal incontinence aggravated
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of safety and efficacy of study treatment
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of >=18 years of age
    2. Patients willing and able to comply with the study procedures
    3. Patients who are mentally competent and able to understand all study requirements
    4. Patients must agree to read and sign the Informed Consent (IC) form prior to any study-related procedures
    5. Female patients of childbearing potential willing to use appropriate methods of contraception (see Section 8.4.6.3). Women considered of childbearing potential shall only be included in the study after a confirmed menstrual period and a negative pregnancy test.
    Inclusion criteria, part 2, related to fecal incontinence:
    6. At Screening (V1), the patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months but equal or less than 10 years, and did not improve sufficiently by conservative treatment performed for at least 3 months
    7. Urge fecal incontinence episodes exceeding 'traces' (as defined by the patient's diary) that occur more than twice a week
    8. Incremental voluntary maximum squeeze pressure on anal manometry is 100mmHg or less in women and 150mmHg or less in men
    9. Ultrasound of the anal canal showing the overall extent of external anal sphincter injury and tear of 180 degrees or less
    E.4Principal exclusion criteria
    1. Patients who, according to the clinical judgment of the investigator, are not suitable for this study
    2. Patients deprived of their liberty by a judicial or administrative decision, patients admitted to a hospital, social institution or who are under a measure of legal protection, patients hospitalized without consent or who are in an emergency
    3. Patients who are currently participating or have participated in another clinical study (testing a medical device or drug) within 30 days prior to screening Visit 1 in this study or have previously participated in this study
    4. Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives, etc.)
    5. Female patients who are pregnant, lactating, or intending pregnancy in the near future and female patients of childbearing potential who are not willing to use appropriate methods (see section 8.4.6.3) of contraception up to Visit 8 or who have a positive pregnancy test (only to be performed in women of childbearing potential)
    6. Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction. This evaluation is based on the current medical history, surgical history, physical examination, anoscopy, anorectal manometry and anal canal ultra-sonography at the screening visit (V1)
    As specific exclusion:
    • Patients with chronic diarrhea or liquid stool that my cause fecal incontinence
    • Patients with rectal fecal impaction that may be the cause of overflow fecal in-continence
    • Patients who may have passive fecal incontinence due to rectal hyposensitivity and lack of urge to defecate
    • Patients in whom the cause of fecal incontinence is considered to be or cannot be excluded to be neuropathy or myelopathy
    • Patients with Goligher class III internal hemorrhoids (patients with Goligher class I and class II internal hemorrhoids are not excluded as they are considered not clinically involved in fecal incontinence)
    7. Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound
    8. Patients who underwent any anorectal surgery within 6 months before screening visit
    9. Patients who underwent a total of two or more external anal sphincter-related surgeries (only one repair after an obstetric injury after vaginal birth is allowed)
    10. Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures
    11. Patients with poorly controlled chronic constipation including obstructed defecation syndrome
    12. Patients with indications against a surgery under anesthesia
    13. Patients with a malignant disease not in remission for 5 years or more
    14. Patients who have undergone radiation therapy of the bowel and pelvis
    15. Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis
    16. Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy
    17. Patients with a diagnosis of chronic inflammatory bowel disease
    18. Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons
    19. Patients with known hypersensitivity to any component of the product (autologous cells, Ringer's lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor [FGF]), gentamicin)
    20. Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator)
    21. Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders
    22. Patients with severe myocardial disorders, irregular pulse or a pacemaker
    23. Patients with implantations of metal components in the electrical stimulation treatment area
    24. Defects of the skin and mucous membranes (injuries, ulcerations) and acute inflammation of the mucous membranes, skin or subcutaneous tissue in the treatment area
    25. Metal implants in the field of treatment
    26. Bleeding in the treatment area
    27. Known mental illnesses, cognitive disorders
    28. Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain
    29. Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment
    E.5 End points
    E.5.1Primary end point(s)
    Changes in frequency of incontinence episodes as measured by the bowel diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92), in both treatment groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 8 (target day 457)
    E.5.2Secondary end point(s)
    1. Frequency of response measured in both treatment arms as a reduction of the frequency of incontinence episodes by more than 50% under treatment. Derived from diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92).

    Additional secondary endpoints:

    2. Frequency of response measured in both treatment arms as a reduction of the frequency of incontinence episodes by more than 50% under treatment. Derived from diary records prior to Visit 5 (target day 123), Visit 6 (target day 184), Visit 7 (target day 275) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92).
    3. Changes in frequency of incontinence episodes at Visit 5 (target day 123), Visit 6 (target day 184), Visit 7 (target day 275) compared to baseline period derived from bowel diary records prior to implantation at Visit 3 (target day 92) in both treatment arms.
    4. Change in the Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) at Visit 8 (target day 457) compared to baseline determined before implantation at Visit 3 (target day 92) in both treatment arms.
    5. Change in the Visual Analogue Scale (VAS) at Visit 5 (target day 123), Visit 6 (target day 184), Visit 7 (target day 275), Visit 8 (target day 457) compared to baseline period derived from bowel diary records prior to implantation at Visit 3 (target day 92) in both treatment arms.
    6. Patient's assessment based on the Fecal Incontinence Quality of life questionnaire (FI-QoL) score at Visit 5 (target day 123), Visit 6 (target day 184), Visit 7 (target day 275), Visit 8 (target day 457) compared to baseline before implantation at Visit 3 (target day 92) in both treatment arms.
    7. Patient's assessment based on the SF-36v2 questionnaire score at Visit 8 (target day 457) compared to baseline before implantation at Visit 3 (target day 92) in both treatment arms.
    8. Investigator's assessment by the Clinical Global Impression (CGI) score at Visit 5 (target day 123), Visit 6 (target day 184), Visit 7 (target day 275), Visit 8 (target day 457) compared to baseline before implantation at Visit 3 (target day 92) in both treatment arms.
    9. Patient's assessment by the Patient Global Impression (PGIC) scale at Visit 5 (target day 123), Visit 6 (target day 184), Visit 7 (target day 275), Visit 8 (target day 457) compared to patient's personal impression of the disease status before cell implantation.
    10. Examinations based on the incontinence diary records.
    11. Changes in anorectal manometry at Visit 8 (target day 457) compared to baseline at screening (Visit 1, day 1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. visit 8 (target day 457)
    2. visit 5 (target day 123), 6 (target day 184), 7 (target day 275)
    3. visit 5 (target day 123), 6 (target day 184), 7 (target day 275)
    4. visit 8 (target day 457)
    5. visit 5 (target day 123), 6 (target day 184), 7 (target day 275), 8 (target day 457)
    6. visit 5 (target day 123), 6 (target day 184), 7 (target day 275), 8 (target day 457)
    7. visit 8 (target day 457)
    8. visit 5 (target day 123), 6 (target day 184), 7 (target day 275), 8 (target day 457)
    9. visit 5 (target day 123), 6 (target day 184), 7 (target day 275), 8 (target day 457)
    11. visit 8 (target day 457)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    United Kingdom
    Austria
    Bulgaria
    Czechia
    France
    Germany
    Italy
    Poland
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months35
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months45
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 290
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After unblinding and analysis of the data, patients of the placebo group will be offered cell therapy within the scope of a separate open label clinical study. The option of cell therapy will only be offered in the case superiority of the aSMDC treatment over placebo is found
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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