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    Summary
    EudraCT Number:2010-021867-34
    Sponsor's Protocol Code Number:IC-01-01-5-006
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-12
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2010-021867-34
    A.3Full title of the trial
    An open, multicenter study to evaluate the urodynamic properties of a local implantation of autologous skeletal muscle-derived cells (SMDCs) in female patients with stress urinary incontinence
    A.3.2Name or abbreviated title of the trial where available
    PD Study
    A.4.1Sponsor's protocol code numberIC-01-01-5-006
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInnovacell Biotechnologie AG - Life Science Center Innsbruck
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameSkeletal Muscle Derived Cells
    D.3.2Product code SMDC
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSkeletal Muscle Derived Cells (SMDC)
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Stress urinary incontinence (SUI) in female patients with predominantly intrinsic sphincter deficiency of moderate severity (Grade 2 and Grade 3)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10066218
    E.1.2Term Stress urinary incontinence
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the functional status of the urethra and particularly the urethral rhabdosphincter by means of urodynamic measures after SMDCs implantation procedure in female patients with SUI.
    E.2.2Secondary objectives of the trial
    Efficacy variables:
    - Change from baseline of maximum urethral closure pressure,
    - Change from baseline of the functional urethral length,
    - Change from baseline of the area under the curve (AUC) of the urethral pressure curve at
    rest,
    - Change from baseline of the IEF score (a response is defined as a reduction by 50% and
    75%),
    - Change from baseline in the Visual Analogue Scale (VAS) score,
    - Change from baseline in the short pad-test results,
    - Change from baseline in the I-QoL score,
    - Examinations based on the micturition diary records,
    - Investigator’s Assessment by the Clinical Global Impression (CGI) score.

    Safety variables:
    - Physical examination,
    - Safety laboratory tests,
    - AEs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of ≥18 to 75 years,
    2. Graded as moderate SUI at the screening visit, according to the classification based on the
    short pad test of Hahn and Fall (1991) Grade 2 (2 - 10 mL leakage) or Grade 3 (11 -
    50 mL leakage),
    3. Diagnosed with SUI, predominantly intrinsic sphincter deficiency, confirmed by urodynamic
    testing (filling cystometry, urethral pressure profile) at screening.
    Patients will only be included in case of:
    - missing detrusor overactivity, i.e. involuntary detrusor contraction,
    - a cystometric capacity >300 mL,
    - compliance of >25 mL/cm H2O,
    - post void residual urine <50 mL,
    - ability to void urine spontaneously,
    - maximum urethral closure pressure <30 cm H2O and/or pressure transmission ratio <75% in
    the midurethra,
    - fixed urethra (no or low hypermobility),
    4. The SUI diagnosis has to be based on the patient’s medical history (including anamnestic
    complaints of involuntary leakage on effort or exertion or on sneezing or coughing) and a
    positive cough test (fixed volume) at the screening visit,
    5. History of inefficient, insufficient, and/or refused PFMT,
    6. Patients who have a negative urine test (dipstick) at visit 0,
    7. Patients willing and able to comply with the study procedures,
    8. Patients who are mentally competent and able to understand all study requirements,
    9. Patients must agree to read and sign the Informed Consent (IC) form prior to any study-
    related procedures,
    10. Female patients of childbearing potential willing to use acceptable methods of
    contraception (birth control pills, barriers, or abstinence).
    E.4Principal exclusion criteria
    1. Pelvic organ prolapse >Stage II (ICS-Classification: The most distal portion of the prolapse is
    more than 1 cm below the plane of the hymen, but protrudes no further than two centimeters
    less than the total vaginal length in cm) detected during the last 12 months prior to patient
    inclusion in the study,
    2. Patients who have a medical history of uncontrolled overactive bladder (OAB) or urinary
    incontinence other than SUI (including anamnestic complaints on involuntary urine leakage
    accompanied by or immediately preceded by urgency, not stress induced),
    3. Patients who have undergone a surgery in pelvis minor due to cancer,
    4. Patients who have undergone any surgery for SUI, including midurethral slings, Burch
    colposuspension, or bulking agents,
    5. Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis
    HCV, acute viral hepatitis HBV, and/or active Syphilis,
    6. Patients diagnosed with any kind of skeletal muscle disease,
    7. Patients who, according to the clinical judgment of the investigator, are not suitable for this
    study,
    8. Patients who are currently participating or have participated in another clinical trial (testing
    medical device or drug) within 30 days prior to the study begin or have previously
    participated in the current clinical study,
    9. Patients who are pregnant, lactating, or intending pregnancy in the near future, and those
    of childbearing potential who are not willing to use acceptable methods of contraception
    (birth control pills, barriers, or abstinence),
    10. Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral
    neuropathic pain,
    11. Patients with compromised immune systems,
    12. Patients complaining about symptoms of acute cystitis or urethritis at visit 0,
    13. Patients who had previously undergone radiation of the pelvis,
    14. Patients with coagulopathy and/or currently being under treatment with anticoagulant
    drugs. However, if the anticoagulant therapy may be changed to heparin treatment prior to
    the therapy, the patients can be included into the study,
    15. Patients with chronic pelvic pain or complaining about pelvic pain syndrome and/or
    dyspareunia,
    16. Patients with uncontrolled narrow-angle glaucoma,
    17. Patients with severe myocardial disorders or irregular pulse, and those with an artificial
    pacemaker,
    18. Patients with implantations of metal components in the electrical stimulation treatment
    area,
    19. Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives,
    etc.),
    20. Patients with a malignant disease not in remission for 5 years or more,
    21. Patients with any persistent chronic bacterial infections as well as local infections as
    indicated by a high value of CRP and confirmed by bacteriological analysis,
    22. Patients with known hypersensitivity to any component of the product (autologous cells,
    ringer’s lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the current study is the change from baseline in the USP measured by the transmission ratio in percent in the midurethra.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    urodynamic
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA12
    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 Information not present in EudraCT
    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
    last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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 Decision2011-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-10
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