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    Summary
    EudraCT Number:2017-000956-25
    Sponsor's Protocol Code Number:15-06
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-05-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000956-25
    A.3Full title of the trial
    CELLEBRATE: An Adaptive, Two-Stage, Double-Blind, Stratified, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study Investigating Autologous Muscle Derived Cells for Treatment of Female Stress Urinary Incontinence Patients
    A.3.2Name or abbreviated title of the trial where available
    CLBT
    A.4.1Sponsor's protocol code number15-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03104517
    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 SponsorCook MyoSite, Incorporated
    B.1.3.4CountryUnited States
    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 supportCook MyoSite, Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIQVIA
    B.5.2Functional name of contact pointProject Manager, ID & Vaccines
    B.5.3 Address:
    B.5.3.1Street Address4820 Emperor Boulevard
    B.5.3.2Town/ cityDurham, NC
    B.5.3.3Post code27703
    B.5.3.4CountryUnited States
    B.5.6E-mailChristina.Benjes@iqvia.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 Muscle Derived Cells
    D.3.2Product code AMDC-USR
    D.3.4Pharmaceutical form Solution 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 INNAMDC
    D.3.9.2Current sponsor codeAMDC
    D.3.9.3Other descriptive nameAMDC
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 numberTissue Engineered Product, not combined; Committee on Advance Therapies, 7 October 2012, EMA/627170/2010
    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
    Female Stress Urinary Incontinence
    E.1.1.1Medical condition in easily understood language
    Accidental loss of urine due to physical activity such as coughing, sneezing, exercise or laughing.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To evaluate the efficacy of a single dose of 150 x 10(6) AMDC-USR in the reduction of stress incontinence episode frequency (EIF) in adult female subjects at 12 months post-treatment.
    E.2.2Secondary objectives of the trial
    To determine the safety of a single dose of 150 x 10(6) AMDC-USR at 12 months and 2 years post-treatment.
    and
    To evaluate improvement in quality of life (QOL) and the extent of reduction of stress IEF after a single dose of 150 x 10(6) AMDC-USR at 12 months and 2 years post-treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult female 50 to 75 years of age who has primary and moderate-to-severe symptoms of SUI (9-45 stress incontinence episodes over 3 days, as recorded in the 3-Day Diary at screening) for a duration of at least 6 months, as confirmed by subject medical history and clinical symptoms, including a focused incontinence evaluation.
    - Must have low hypermobility of the urethra with Valsalva Q-tip ≤ 30º.
    - Must be willing and able to comply with the study procedures, be
    mentally competent and able to understand all study requirements, and
    must agree to read and sign the informed consent form prior to any
    study-related procedures.
    - Must have completed 100% of their screening 3-Day Diary Evening
    Reports.
    - Must be willing to use acceptable methods of contraception if of childbearing potential.
    E.4Principal exclusion criteria
    - Symptoms of only urge incontinence as confirmed by basic evaluation of etiology from a subject medical history, including a focused incontinence history.
    - Symptoms of mixed urinary incontinence where urge incontinence is the predominant factor, defined by the 3-Day Diary as having more than 2x the number of urge leaks than stress leaks (Assessment of predominant urge incontinence is based on the medical record, physician's assessment, and a one-time 3-Day Diary).
    - Has not previously attempted conservative treatment prior to signing the informed consent (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, PFMT).
    - Morbidly obese (BMI ≥ 35).
    - Have medically diagnosed autoimmune disease(s) or other types of immune system compromise or disorder that has the potential for an exacerbation of the symptoms that may cause the subject to become susceptible to infections, or may require systemic corticosteroid/immunosuppressive treatment during the study.
    - Has known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate, DMSO, or ampicillin that medically warrants exclusion as determined by the physician.
    - History of cancer in pelvic organs, ureters, or kidneys.
    - Any cancer that has undergone treatment within the past 12 months.
    - Actively undergoing treatment with stimulation neuromodulation system (sacral, tibial, or percutaneous tibial nerve stimulation) within the last 6 months or planned during the course of the study.
    - Pregnant, lactating, or plans to become pregnant during the course of the study.
    E.5 End points
    E.5.1Primary end point(s)
    A comparison between the AMDC-USR and placebo groups in the percentage of subjects with ≥ 75% reduction in stress IEF as recorded in the 3-Day Diary at 12 months compared with baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    A comparison between the AMDC-USR and placebo groups for:
    - Change in mean I-QOL score as determined by I-QOL score and subscores at 12 months compared with baseline;
    - Percentage of subjects with ≥ 50% reduction in stress IEF as recorded in the 3-Day Diary at 12 months compared with baseline;
    - Percentage of subjects with continence restored defined as 0 or 1 stress incontinence episode as recorded in the 3-Day Diary at 12 months;
    and
    - Improvement (reduction) in stress IEF as recorded in the 3-Day Diary at 12 months compared with baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 Yes
    E.8.1.7.1Other trial design description
    Placebo treated patients will be given option to receive AMDC-USR after their 12 months follow up.
    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 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 concerned2
    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 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
    United Kingdom
    United States
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state144
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 320
    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)
    Patients are under physician care prior to enrollment in the study and are expected to remain under the supervision of the responsible physician. No specific sponsor related treatment or care is anticipated after end of participation and no limits are expected on the provision of standard care following participation.
    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 Decision2018-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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