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    The EU Clinical Trials Register currently displays   43872   clinical trials with a EudraCT protocol, of which   7291   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-005399-21
    Sponsor's Protocol Code Number:IC-01-02-2-010
    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:2021-11-19
    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 number2021-005399-21
    A.3Full title of the trial
    Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a single arm, open label, interventional, follow-up study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial treating fecal incontinence patients with muscle cell treatment
    A.3.2Name or abbreviated title of the trial where available
    STEFFI-FU
    A.4.1Sponsor's protocol code numberIC-01-02-2-010
    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 AG
    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 AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInnovacell AG
    B.5.2Functional name of contact pointInnovacell AG
    B.5.3 Address:
    B.5.3.1Street AddressMitterweg 24
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone numberÖster512573680
    B.5.5Fax numberÖster5125736805
    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 nameautologuous 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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeaSMDC
    D.3.9.3Other descriptive nameautologous muscle derived cells
    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 numberEMA/CAT/573420/2009
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fecal incontinence (FI)
    E.1.1.1Medical condition in easily understood language
    Accidental bowel leakage
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 100000004856
    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 who participated in the phase IIb STEFFI study (IC-01-02-02-007) and were randomized to placebo
    2. Patients must agree to read and sign the Informed Consent (IC) form prior to any study-related procedures
    3. Patients willing and able to comply with the study procedures
    4. Patients who are mentally competent and able to understand all study requirements
    5. Female patients of childbearing potential willing to use appropriate methods of contraception. Women considered of childbearing potential shall only be included in the study after a confirmed menstrual period and a negative pregnancy test.
    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 (test-ing a medical device or drug) within 30 days prior to screening Visit 1
    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 of contraception up to Visit 5 or who have a positive pregnancy test (only to be performed in women of childbearing potential)
    6. Patients who underwent any anorectal surgery within 6 months before screening visit
    7. Patients with indications against a surgery under anesthesia
    8. Patients with a malignant disease not in remission for 5 years or more
    9. Patients who have undergone radiation therapy of the bowel and pelvis
    10. Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis
    11. Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy
    12. Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons (4 weeks)
    13. 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]), gentamycin)
    14. Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepa-titis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator)
    15. Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders
    16. Patients with severe myocardial disorders, irregular pulse or a pacemaker
    17. Patients with implantations of metal components in the electrical stimulation treatment area
    18. Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain
    19. 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 incontinence diary records prior to Visit 5 compared to the baseline period from diary records prior to biopsy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 5 (3 months after implantation) versus baseline ( 3 weeks after screening)
    E.5.2Secondary end point(s)
    1.Suitability to use an e-diary for incontinence recording
    2.Safety (Physical examination, vital signs, standard hematology, blood chemistry)
    3.Other (Pregnancy, concomitant medication)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Visit 5 (3 months after implantation versus Visit 2)
    2. Visit 1 (screening), 2 (21 days after screening at biopsy), 3 (day of implantation), 4 (1 day after implantation), 5 (3 months after implantation)
    3. Visit 1 (screening), 2 (21 days after screening at biopsy), 3 (day of implantation), 4 (1 day after implantation), 5 (3 months after implantation)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 months6
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) No
    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 state10
    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)
    None
    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 Decision2022-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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