Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004672-35
    Sponsor's Protocol Code Number:09-025
    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:2014-03-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-004672-35
    A.3Full title of the trial
    A Prospective Nonrandomized Study of Autologous Muscle Derived cell (AMDC) Transplantation for Treatment of Fecal Incontinence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the Safety of Cook Myosite Incorporated Muscle Cells (derived from the patients own muscle) in patients suffering from fecal incontinence
    A.3.2Name or abbreviated title of the trial where available
    Cook MyoSite AMDC Fecal Incontinence Clinical Study 09-025
    A.4.1Sponsor's protocol code number09-025
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01600755
    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 organisationWilliam Cook Europa, ApS
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressSandet 6
    B.5.3.2Town/ cityBjaeverskov
    B.5.3.3Post code4632
    B.5.3.4CountryDenmark
    B.5.4Telephone number4556868942
    B.5.6E-mailDNK-clinical-studies@cookmedical.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 for treatment of fecal incontinence, AMDC-ASR
    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 INNNot Applicable (N/A)
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeAMDC-USR
    D.3.9.4EV Substance CodeAS1
    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 combinedÍž Committee on Advanced Therapies, 7 OCT 2010, 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fecal incontinence in men and women
    E.1.1.1Medical condition in easily understood language
    Fecal incontinence in men and women
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055507
    E.1.2Term Fecal incontinence aggravated
    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
    The primary objective of the study is to determine the incidence of product- or procedure-related adverse events associated with the use of AMDC in the treatment of patients with fecal incontinence within a 12 months post-treatment period.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to study the effect of AMDC treatment for fecal incontinence at 1, 3, 6, and 12 months post-treatment based on clinical evaluation, the patient’s personal fecal incontinence diary and a fecal incontinence quality of life assessment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient has primary symptoms of fecal incontinence, as confirmed by patient medical
    history and physical examination, including visual inspection, digital rectal
    examination, anoscopy and/or sigmoidoscopy
    - Patient has a Wexner score of ≥ 5 at baseline
    - Patient has failed conservative treatment (e.g. dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 1 month prior to enrollment
    E.4Principal exclusion criteria
    - Evidence of faecal impaction or overflow on digital rectal examination
    - Patient has undergone a gracilis sling repair, insertion of an artificial sphincter, or anorectal operation that has caused damage to sphincter that might confound the study results
    - Patient has Inflammatory Bowel Disease (Crohn’s disease, ulcerative colitis)
    - Patient has known significant pelvic floor abnormalities with high pressure instability,significant rectocele, or prolapse beyond the introitus
    - Patient is less than 18 years of age
    - Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study
    - Patient is morbidly obese (BMI ≥ 35)
    - Patient has uncontrolled type I or type II diabetes
    - Patient is not suitable for muscle biopsy as determined by physician
    - Patient has positive diagnosis for Hepatitis B, Hepatitis C, Syphilis or HIV at screening
    - Patient has a compromised immune system due to disease state, chronic
    corticosteroid use or other immunosuppressive therapy
    - Patient is simultaneously participating in another investigational drug or device study or the patient has completed the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study
    - Patient is unable or unwilling to provide informed consent
    - Patient is unable or unwilling to commit to the follow-up procedures
    - Patient is febrile (defined as temperature ≥ 38.5 °C)at Time of Cell Delivery
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of safety is the incidence of treatment-related serious adverse events (SAEs) and the incidence of protocol-defined treatment or procedure related adverse events associated with the use of AMDC at 12 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome evaluation will be at 12 months after the initial treatment with AMDC.
    E.5.2Secondary end point(s)
    Secondary outcome measures will include the following:
    Effectiveness of the AMCD injection as measured by changes from baseline in:

    1) the frequency and nature of incontinent episodes at 1, 3, 6, and 12 months post-treatment as measured by a fecal incontinence diary

    2) the Wexner incontinence score at 1, 3, 6, and 12 months post-treatment

    3) fecal incontinence quality of life score (FIQL)scores at 1, 3, 6, and 12 months post-treatment

    4) sphincter functioon as measured by endeanal ultrasound at 12 months

    5) sphincter morphology as measured by anorectal manometry at 12 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondaty endpoints will be assessed at 1, 3, 6, and 12 months post-injection.
    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 No
    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 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 concerned1
    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
    Canada
    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
    1. All patients complete the required study followup,or are completed due to withdrawal, lost to followup,or death.

    2. The Data Safety Monitoring Board identifies a safety concern that would cause them to recommend stopping the trial. See 1 for completion of study visits.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 50
    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)
    Further treatment with AMDC product will not be available after the end of the study and patients will return to standard of care treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 22:20:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA