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    Summary
    EudraCT Number:2008-004286-25
    Sponsor's Protocol Code Number:CX-401/FATT2
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-004286-25
    A.3Full title of the trial
    Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.
    FATT 2: Fistula Advanced Therapy Trial (II)
    A.3.2Name or abbreviated title of the trial where available
    FATT II
    A.4.1Sponsor's protocol code numberCX-401/FATT2
    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 SponsorCELLERIX S.A.
    B.1.3.4CountrySpain
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/303
    D.3 Description of the IMP
    D.3.1Product nameASCs: Adipose derived Stem Cells
    D.3.2Product code Cx401
    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 IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNASCs
    D.3.9.3Other descriptive nameSuspension of adipose derived autologous adult stem cells
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8 000 000 to 12 000 000
    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
    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 placeboIntralesional use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complex perianal fistula in perianal Crohn´s disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10002156
    E.1.2Term Anal fistula
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of intralesional administration of eASCs (CX-401) when added to standard surgical care and drainage for the treatment of complex perianal fistulas in patients with CD.
    E.2.2Secondary objectives of the trial
    •To evaluate the safety of intralesional administration of eASC’s (CX-401) when given at baseline with a possible repeat dose at Week 12, and a follow-up period of 12 weeks.
    • To evaluate the effect of intrafistular administration of eASC’s (CX-401) on the incidence of complications of complex fistulas in patients with CD (such as abscesses or fluid collections) using MRI.
    • To compare the use of eASC’s (CX-401) with placebo with regard to the fistular relapse rate.
    • To obtain data regarding prevention of invasive surgical procedures and use of additional therapies.
    • To obtain QoL data.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    "Inflammation substudy (Biomarker Evaluation)" (only applicable at selected sites in Spain)

    SUBSTUDY OBJECTIVES
    1.- To determine both the frequency of the population of regulatory T cells (Treg) and the ratio Treg/Th17 in the blood of patients from FATT-2 study. This research may potentially link the frequency of Tregs in the blood of patients as an in vivo maker for Ontaril efficiency.
    2.- To investigate the levels of pro-inflammatory (Th1) cytokines and compare them to the levels of anti-inflammatory (Th2) cytokines. Analysis is designed to correlate the healing of the fistula induced by the ASC treatment with cytokine levels.
    E.3Principal inclusion criteria
    A patient can be included in the study if he/she meets ALL the criteria listed below:
    1. Signed informed consent.
    2. Patients with CD diagnosed at least 12 months earlier in accordance with accepted clinical,
    endoscopic, anatomical/topographical and/or radiologic criteria.
    France and Italy only:Patients with CD diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomical/topographical and/or radiological criteria, unresponsive (treatment failure and/or intolerance and/or contraindication) to conventional treatment, including anti-TNF. Treatment failure means persistence or recurrence of fistula-related discharge despite correctly conducted induction treatment with anti-TNF antibodies with at least 3 infusions/injections. It is, however, possible to authorize inclusion of patients who do not tolerate anti-TNF antibodies (allergy) and, in consequence, have not received a complete course of anti-TNF antibody treatment. Patients to whom treatment with anti-TNF agent is contraindicated, may also be included if they fulfill other eligibility criteria.
    3. Presence of complex perianal fistula with up to 3 external openings, assessed by MRI. The blinded fistulae branches visible though MRI are not considered fistula tracts but branches of the main tract. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria:
    - High fistulas (high inter-sphincteric, high trans-sphincteric, extra-sphincteric or
    supra-sphincteric)
    - Presence of 3 or fewer external openings associated to a complex perianal fistula.
    4. Non-active or mildly active luminal CD defined by a CDAI ≤220.
    5. Patients of either sex aged 18 years or older. Good general state of health according to clinical history and a physical examination.
    6. Women of a childbearing age with negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both men and women should use appropriate birth control methods defined by the investigator.
    E.4Principal exclusion criteria
    A patient cannot be included in the study if he/she meets ANY of the criteria listed below
    1. Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active Crohns disease requiring immediate therapy, assessed by rectosigmoidoscopy
    2. CDAI >220.
    3. Presence of an abscess or collections >2 cm, unless a complete surgical debridement of the area has been performed, including drainage of the collection(s) and an MRI scan confirms absence of (residual) abscess before randomization.
    4. Presence of setons. If present at screening they should be removed prior to treatment administration.
    5. Presence of >3 external openings.
    6. Rectal and/or anal stenosis.
    7. Treatment with infliximab or any other anti-TNF agent in the 8 weeks before the cell treatment administration.
    8. Patients having received adalimumab in the 4 weeks before the cell treatment
    administration.
    9. Treatment with tracrolimus or cyclosporine in the 4 weeks before the cell treatment administration.
    10. HIV, HBV, HCV or treponema infection.
    11. Persistent chronic bacterial infections of temporary nature as well as local infections unless succesfully treated prior liposuction, such as syphilis, brucellosis, typhus, melioidosis, qfever, meningitis, or other.
    12. Renal impairment defined by creatinine clearance below 60 ml/min calculated using Cockcroft-Gault formula (see appendix I) or the following laboratory ranges:
    Total bilirubin ≥ 1.5 x upper limit of normal (ULN) AST and ALT ≥ 2.5 X ULN
    Serum creatinine ≥ 1.5 ULN
    13. Known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
    14. Malignant tumor or patients with a prior history of malignant tumors.
    15. Current or recent history of abnormal, severe, progressive, uncontrolled liver function, anemia, hepatic, hematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric ,or cerebral disease.
    16. Congenital or acquired immunodeficiencies.
    17. Known allergies or hypersensivity to antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; HSA; DMEM; materials of bovin origin; local anesthetics or gadolinium (MRI contrast).
    18. Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia).
    19. Liposuction with extraction of at least 100 cm3 of fat from the abdominal wall is technically unfeasible or the patient does not consent to the procedure.
    20. Major surgery or severe trauma within the previous 6 months.
    21. Pregnant or breastfeeding women.
    22. Patients who do not wish to or cannot comply with study procedures.
    23. Patients currently receiving, or having received within 3 months prior to enrolment into this clinical study, any investigational drug.
    24. Patients unlikely to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of anti-TNF exposed patients with complete closure of their treated complex perianal fistula at Week 24. Complete closure of the fistula is defined as:
    • Absence of drainage/suppuration of the fistula through the external orifice, either spontaneously or when applying pressure, and
    • Complete re-epithelization of the external orifice (clinical evaluation), and
    • Absence of fluid collections >2 cm directly related to the treated fistula tract, as measured by MRI, in the longest diameter.
    Clinically, complete closure must be confirmed at both, the Week 24 and the Week 26 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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Sub-study to investigate autoimmune response (see Protocol section 10 – 1.2 Objectives)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.4Double blind No
    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
    Sub-study to investigate autoimmune response (see Protocol section 10 – 1.2 Objectives)
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Final study: last visit carried out. The last patient included may not need the second dose, this would mean that the last visit will correspond to a patient included previously who needs a second dose.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-09-11. Yes
    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 184
    F.4.2.2In the whole clinical trial 196
    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 the patients will receive standard of care.
    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 Decision2008-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
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