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    Summary
    EudraCT Number:2009-011797-15
    Sponsor's Protocol Code Number:IC-01-01-4-003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-16
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-011797-15
    A.3Full title of the trial
    Skeletal muscle-derived cell implantation in female patients with stress urinary incontinence: a multicenter, randomized, parallel-group, placebo-controlled clinical study
    A.3.2Name or abbreviated title of the trial where available
    SUITE study
    A.4.1Sponsor's protocol code numberIC-01-01-4-003
    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
    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 SMDCs
    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.3.11 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.IMP: 2
    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 SMDCs
    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.3.11 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Yentreve®
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDULOXETINE
    D.3.9.1CAS number 116539594
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) Information not present in EudraCT
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    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 predominately intrinsic sphincter deficiency of moderate severity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066218
    E.1.2Term Stress urinary incontinence
    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 find the optimal cell count for functional regeneration
    of the urethral sphincter, including safety evaluation.
    E.2.2Secondary objectives of the trial
    Efficacy variables:
    • Change from baseline in the IEF score for comparison of each pair wise
    combination of treatment groups not considered in the primary analysis,
    • Change from screening in the short pad-test results,
    • Change from baseline in the I-QoL score,
    • Change from baseline in the Visual Analog Scale (VAS) score,
    • Frequency of responders regarding the IEF score; different definitions of
    response (reduction by 50% and 75%) will be used,
    • Amount of urinary volume lost during incontinence episodes,
    • Correlation between fluids taken and IEF score,
    • Investigator’s assessment by Clinical Global Impression (CGI) score.

    Standard safety examinations like comparison of routine laboratory measures and
    frequency, type, intensity, and seriousness of AEs including Suspected Unexpected
    Serious Adverse Reactions (SUSARs) will be provided.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of ≥ 18 years of age,
    • Age limit approved for Germany: 18 – 75 years,
    • Age limit approved for the Czech Republic: 18 – 65 years.
    2. Graded as moderate SUI at 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
    ambulatory urodynamic testing (filling cystometry) at screening.
    Patients will be included only in case of:
    • missing detrusor overactivity, i.e. involuntary detrusor contraction with a
    pressure <15 cm H2O,
    • a cystometric capacity >300 mL,
    • compliance of >25 mL/cm H2O,
    • post void residual urine <50 mL,
    • ability to void urine spontaneously.
    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 pelvic floor muscle training
    (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 informed consent 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
    [Ref a)1],
    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, i.e. midurethral slings,
    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 (only valid for patients in cell
    implantation groups), 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 suffering from major depressive disorders, and/or generalized anxiety
    disorders,
    17. Patients treated with monoamine oxidase inhibitors (MAOIs) and/or sedatives,
    serotonergic drugs (including triptans), alpha(1)-adrenoreceptor antagonists,
    18. Patients with a history of: duloxetine treatment within a period of 6 months
    prior to patient inclusion, liver disease resulting in hepatic impairment,
    uncontrolled hypertension, severe renal impairment, hypersensitivity to
    hydrochloride, and/or treatment with CYP1A2 inhibitors as fluvoxamine,
    ciprofloxacin, or enoxacine, and/or CYP3A4 inducers such as St. John’s wort,
    19. Patients with uncontrolled narrow-angle glaucoma,
    20. Patients with severe myocardial disorders or irregular pulse, and those with an
    artificial pacemaker,
    21. Patients with implantations of metal components in the electrical stimulation
    treatment area,
    22. Patients dependent from the sponsor, CRO, or the investigator (e.g.
    employees, relatives, etc.),
    23. Patients with malignant disease not in remission for five years or more,
    24. Patients with any persistent chronic bacterial infections as well as local
    infections,
    25. 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)
    Change from baseline (visit -5) of the Incontinence Episode Frequency (IEF) score. The IEF is calculated as number of incontinence episodes that occurred during 7 days receding a visit.
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 245
    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)
    All patients will be included in a separate 9-month follow-up study. The patients who
    had relapse of their SUI symptoms will be offered an adequate active treatment.
    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 Decision2010-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-06
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