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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2006-003370-95
    Sponsor's Protocol Code Number:Cx401/FATT1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-003370-95
    A.3Full title of the trial
    "A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologous stem cells for the treatment of complex perianal fistulas in patients without inflammatory bowel disease" FATT I: Fistula Advanced Therapy Trial (I)
    A.3.2Name or abbreviated title of the trial where available
    FATT 1
    A.4.1Sponsor's protocol code numberCx401/FATT1
    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.L.
    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/E/05/303
    D.3 Description of the IMP
    D.3.1Product nameASCs:adipose derived stem cells
    D.3.2Product code ASCs
    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.3.10.2Concentration typeequal
    D.3.10.3Concentration number20+ 40 millions
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name TISSUCOL DUO
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER LABORATORIES
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTISSUCOL DUO (5.0ML) FIBRIN TISSUE ADHESIVE
    D.3.4Pharmaceutical form Gel
    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 INNFIBRIN
    D.3.9.3Other descriptive nameTISSUCOL
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) Information not present in EudraCT
    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 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
    Treatment of complex perianal fistulas in patients without inflammatory bowel disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10002156
    E.1.2Term Anal fistula
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the efficacy of ASCs versus ASCs plus fibrin adhesive versus fibrin adhesive for closure of complex perianal fistulas not associated to inflammatory bowel disease. 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
    1. Evaluate the changes over time in the clinical complexity of the fistula in patients treated with ASCs, ASCs plus fibrin adhesive, and fibrin adhesive alone.
    2. Compare the efficacy of ASCs vs ASCs plus fibrin adhesive and fibrin adhesive alone, for clinical evaluated closure of complex perianal fistulas not associated to inflammatory bowel disease. 3.Evaluate the safety in patients treated with ASCs vs ASCs plus fibrin adhesive versus fibrin adhesive alone. 4.Evaluate the quality of life of patients treated with ASCs in comparison to those treated wit ASCs plus fibrin adhesive and with fibrin adhesive alone (SF36 score). 5. Evaluate the degree of fecal incontinence (if any) using Wexner clinical scale (Wexner incontinence score) in patients treated with ASCs in comparison to those treated wit ASCs plus fibrin adhesive and with fibrin adhesive alone 6.Evaluate the number of surgeries avoided in patients treated with ASCs compared to those treated with fibrin adhesive alone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a.Patient with a complex perianal fistula amenable to local treatment with ASCs, as judged by the investigator after a clinical examination and MRI have been conducted.
    b.Patient of any sex aged 18 years or older
    c.Women of childbearing age should have a negative serum or urine pregnancy test and not be lactating before study entry. Both men and women should use adequate birth control methods as defined by the investigator.
    d.Seton presence is allowed at the time of study entry and until cells (in groups receiving ASCs) or fibrin adhesive are implanted.
    e.No condition that may prevent the patient from following the study procedures until 26 weeks of follow?up are completed is foreseen.
    f.Patient should give his/her signed, written informed consent.
    E.4Principal exclusion criteria
    a.Patient has been diagnosed with inflammatory bowel disease, as documented by radiology/endoscopy/histopathology.
    b.Patient has a rectovaginal fistula.
    c.Patient is a pregnant or lactating woman
    d.Patient has acute sepsis at the time of study entry
    e.A liposuction to draw al least 100 cc3 of fat from the abdominal wall is not technically feasible, or does not want this procedure to be performed.
    f.Patient needs surgery in the perianal region for reasons other than fistulas at the time of study entry, or is expected to possibly need any type of surgery in that area in the next 26 weeks. Abscess drainage is permitted.
    g.Presence of two or more complex perianal fistulas.
    h.Patient has collections >2 cm in MRI. If such collections exist, the patient may participate in the study if the investigating surgeon performs a complete toilette of the area, draining collections, and the absence of such collections or other collections >2 cm is shown in a subsequent MRI.
    i.Patient is allergic to local anesthetics or Gadolinium (MRI contrast agent)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion or patients in whom the external openings of the treated perianal fistula are closed clinically evaluated (absence of suppuration through the external opening of the fistula, spontaneously and by pressure, and the complete re-epithelization of the external opening) and also by MRI (absence of collections >2cm associated to the fistulous tract) after the ASC treatment cycle (1 + 1) with a dose of approximately 20 million ASCs in the first administration and 40 millions in the second administration, compared to the proportion of patients treated with ASCs plus fibrin adhesive or with fibrin adhesive alone, 24 weeks after receiving the first dose of study medication (26 in patients with a second dose.)
    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 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 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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    1 año y 6 meses
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 207
    F.4.2.2In the whole clinical trial 207
    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 Decision2007-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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