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    Summary
    EudraCT Number:2008-004286-25
    Sponsor's Protocol Code Number:CX-401/FATT2
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-15
    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 ConcernedNetherlands - Competent Authority
    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 perianal Crohn’s disease.
    FATT II: 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 EID50/dose 50% Embryo Infective Dose/dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20000000 to 40000000
    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
    To Compare the efficacy of eASCs versus placebo for closure of complex perianal fistula in perianal Crohn´s disease after 24 weeks from the initial administration of eASCs or placebo. Fistula closure is defined as absence of suppuration of the fistula through the external orifice, spontaneously and by pressure, and complete re-epithelization of the external orifice in the clinical evaluation and absence of collections > 2 cm directly related to the fistula tract treated, as measured by MRI.
    E.2.2Secondary objectives of the trial
    • To compare the efficacy of eASCs versus placebo for closure of complex perianal fistula in perianal Crohn´s disease after 12 weeks of follow-up.
    • To evaluate the changes over time in the Perianal Disease Activity Index (PDAI) and Crohn´s Disease Activity Index (CDAI).
    • To evaluate the changes over the time in the MRI Score of Severity (MSS).
    • To assess the Subjects’ quality of life.
    • To assess the incidence of luminal relapse and the avoided surgeries.
    • To evaluate the safety of the study treatments.
    E.2.3Trial contains a sub-study No
    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. Subjects with Crohn’s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
    3. Presence of complex perianal fistula with 3 or fewer fistulous tracts assessed by MRI.
    4. Subjects with persistent and active complex perianal fistula and non active luminal CD defined by a CDAI &#8804; 200.
    4.1. 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 (tracts) associated to a complex perianal fistula.
    - Pain/fluctuation
    5. Subjects of either sex aged over 18 years. Good general state of health according to the findings of the clinical history and the physical examination.
    6. Women of a childbearing age with negative serum or urine pregnancy test (sensitive to 25 IU 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 luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
    2. Subjects with a CDAI &#8805;201.
    3. Subjects with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start.
    4. The presence of setons unless removed prior to treatment start.
    5. Presence of >3 fistulous tracts and/or external openings.
    6. Subjects with rectal and/or anal stenosis evaluated by rectoscopy or EUA.
    7. Subjects who have received infliximab or any other anti-TNF agent in the 8 weeks before the cell treatment administration.
    8. Subjects who have received tracrolimus or cicolporine in the 4 weeks before the cell treatment administration.
    9. Subjects with rectovaginal fistula, anal fistula(s), and/or non-perianal enterocutaneous fistula.
    10. Subjects with HIV, HBV, HCV or treponema infection, whether active or latent.
    11. Subjects with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
    12. Subjects with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or Subjects with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years.
    13. Subjects with cardiopulmonary disease which, in the opinion of the investigator, is unstable or sufficiently serious to exclude the patient from the study.
    14. Subjects with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from the study.
    15. Subjects with congenital or acquired immunodeficiencies.
    16. Subjects with abnormal laboratory test findings that contraindicate their inclusion in the study.
    17. Subjects allergic to local anesthetics or gadolinium (MRI contrast).
    18. MRI is unfeasible, (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. Subjects in need of surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or a need for such surgery is foreseen in this region in the 26 weeks after treatment administration.
    21. Subjects who have suffered major surgery or severe trauma in the prior 6 months.
    22. Pregnant or breastfeeding women.
    23. Subjects who do not wish to or cannot comply with study procedures.
    24. Subjects currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.
    25. Subjects unlikely to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy as percentage of subjects in whom, at 24 weeks, the external openings of treated perianal fistula have closed.
    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
    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
    Autoimmune response (see Protcol 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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 2008-08-15. 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 156
    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 Decision2008-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-28
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