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    Summary
    EudraCT Number:2010-021871-10
    Sponsor's Protocol Code Number:IC-01-01-05-004
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-22
    Trial results View 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 number2010-021871-10
    A.3Full title of the trial
    A multicenter, randomized, double-blinded, parallel-group, placebocontrolled study to assess the efficacy and safety of skeletal muscle-derived cell implantation in female patients with stress urinary incontinence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of this clinical study is to show efficacy and safety of cells in patients suffering from stress urinary incontinence and to show superiority of cells in female patients with stress urinary incontinence over placebo.
    A.3.2Name or abbreviated title of the trial where available
    Innovation
    A.4.1Sponsor's protocol code numberIC-01-01-05-004
    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 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 supportInnovacell Biotechnologie AG - Life Science Center Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPierrel Research Europe GmbH
    B.5.2Functional name of contact pointInternational Project Management
    B.5.3 Address:
    B.5.3.1Street AddressZeche Katharina 6
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45307
    B.5.3.4CountryGermany
    B.5.4Telephone number004920189900
    B.5.5Fax number00492018990101
    B.5.6E-mailoffice.europe@pierrel-research.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 nameSkeletal Muscle-Derived Cells
    D.3.2Product code SMDC
    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 INNSkeletal Muscle Derived Cells
    D.3.9.2Current sponsor codeSMDC
    D.3.9.3Other descriptive nameSkeletal Muscle Derived Cells
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200000
    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) 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 numberTissue enginneered Not combined EMEA/CAT/492229/2009
    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 placeboSolution 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
    Stress urinary incontinence (SUI) of moderate severity (Grade 2 and Grade 3) in female patients
    E.1.1.1Medical condition in easily understood language
    Stress urinary incontinence is the loss of small amounts of urine associated with movements that increase pressure and thus increase pressure on the bladder.
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 main objective is to show superiority of skeletal muscle-derived cells (SMDCs) over placebo in female patients with SUI
    E.2.2Secondary objectives of the trial
    no secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female patients will be eligible for inclusion into the study if all of the following criteria are met:
    1. Patients of ≥ 18 years of age
    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, 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,
    • no or low hypermobility of the urethra with Valsalva Q-tip <30°,
    • 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 Screening,
    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 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).

    Interim Inclusion Criteria:
    Patients with an IEF of at least 12 within the last 7 days prior to the visits Visit-1 and Visit 0 (as evaluated from the patient’s micturition diary) and with an I-QoL ≤ 65 as evaluated at Visit-1 and Visit 0 from the I-QoL questionnaire.
    E.4Principal exclusion criteria
    A patient will not be eligible for inclusion in the study if any of the following criteria are met:
    1. Pelvic organ prolapse > Stage I [International Continence Society (ICS) -Classification: the most distal portion of the prolapse is 1 cm or less proximal or
    distal to the plane of the hymen] 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, 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 during the study, 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,
    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 suffering from major depressive disorders, and/or generalized anxiety disorders,
    17. Patients with a history of: duloxetine treatment within a period of 6 months prior to patient inclusion,
    18. Patients with severe myocardial disorders or irregular pulse, and those with an artificial pacemaker,
    19. Patients depending on 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 clinically relevant increase in C-reactive protein (CRP) (i.e. > 35 mg/mL) and confirmed by bacteriological analysis,
    22. Patients with known hypersensitivity to any component of the product (autologous cells, ringer’s lactate, human
    serum albumin, dimethylsulfoxid (DMSO), bovine serum albumin, fibroblast growth factor).

    Interim Exclusion Criterion:
    Patients with diarrhea at time of procurement (Visit -1).
    E.5 End points
    E.5.1Primary end point(s)
    1. Responder rate; response is defined as a reduction in the IEF of 75% from baseline (Visit 0) to Visit 4. The IEF is calculated as number of incontinence
    episodes that occurred during 7 days preceding a visit.
    2. Change from baseline (Visit 0) to Visit 4 of the SUI complaints measured by the I-QoL sum score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    V-1
    V0
    V2
    V3
    V4
    E.5.2Secondary end point(s)
    Efficacy variables

    • Comparison of response rates by Fisher’s Exact test one-sided at visit 6 analogously to the primary criterion,
    • Comparison of the pre-post difference of the I-QoL sum score by t-test one-sided at visit 6 analogously to the primary criterion,
    • Frequency of responders regarding the IEF score; different definitions of response (reduction by 50% and 90%) will be used,
    • Change from baseline (Visit 0) in the I-QoL subscale scores,
    • Change from baseline (Visit 0) in the IEF score,
    • Change from screening in the short pad-test results,
    • Change from baseline (Visit 0) in the VAS score,
    • Investigator’s assessment by the Clinical Global Impression (CGI) score.

    Standard safety examinations like comparison of routine laboratory measures and frequency, type, intensity, and seriousness of adverse events (AEs) including Suspected Unexpected Serious Adverse Reactions (SUSARs) will be provided.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Change from baseline in the IEF score:
    V-1, V0, V2, V3, V4
    • Change from baseline (Visit 0) in the I-QoL subscale scores: V-1, V0, V2, V3, V4
    • Change from screening in the short pad-test results: Screening, V2, V3, V4
    • Change from baseline (Visit 0) in the VAS score: V-1, V0, V2, V3, V4
    • Investigator’s assessment by the Clinical Global Impression (CGI) score: Screening, V3, V4
    • Standard safety examinations: Screening, V0, V1, V1a, V2, V3, V4
    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 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.8.2.4Number 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 EEA29
    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
    Austria
    Bulgaria
    Czech Republic
    France
    Germany
    Italy
    Netherlands
    Romania
    Slovenia
    Spain
    Switzerland
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months32
    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 months32
    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.1.2.1Number of subjects for this age range: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 92
    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 360
    F.4.2.2In the whole clinical trial 372
    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)
    The inclusion in a separate follow-up study for additional 12 months is planned for all patients from this phase III study.

    Patients who did not respond to the treatment will be offered a SMDC therapy in the scope of a separate open-label study after the end of the current study.
    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 Decision2012-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-09
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