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    Summary
    EudraCT Number:2011-006064-43
    Sponsor's Protocol Code Number:Cx601-0302
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-006064-43
    A.3Full title of the trial
    A phase III, randomised, double blind, parallel group, placebo controlled,
    multicentre study to assess efficacy and safety of expanded allogeneic
    adipose-derived stem cells (eASCs) for the treatment of perianal fistulising
    Crohn's disease over a period of 24 weeks and an extended follow-up
    period up to 104 weeks. ADMIRE-CD study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.
    A.4.1Sponsor's protocol code numberCx601-0302
    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 SponsorTiGenix, S.A.U.
    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 supportTiGenix, S.A.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTiGenix S.A.U.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressParque Tecnológico de Madrid
    B.5.3.2Town/ cityTres Cantos. Madrid
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491804 9264
    B.5.5Fax number+3491804 9263
    B.5.6E-mailmariepaule.richard@tigenix.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/667
    D.3 Description of the IMP
    D.3.1Product nameAllogenic eASCs 5 million cells/ml suspension for injection. CX601
    D.3.2Product code Cx601
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 INNNot applicable
    D.3.9.2Current sponsor codeAllogenic eASCs
    D.3.9.3Other descriptive nameExpanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000000
    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) Yes
    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 No
    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 No
    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 placeboIntralesional use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perianal fistulising Crohn´s disease
    E.1.1.1Medical condition in easily understood language
    Treatment for perianal fistulising Crohn´s disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10002156
    E.1.2Term Anal fistula
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy and safety of eASCs compared to placebo for the
    treatment of perianal fistulising Crohn's disease over a 24-week and an
    extended follow-up period up to 104 weeks.
    E.2.2Secondary objectives of the trial
    There are no secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Signed informed consent*.
    (2) Patients with Crohn’s Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria.
    (3) Presence of complex perianal fistulas with a maximum of 2 internal openings and a maximum of 3 external openings, assessed by clinical assessment and MRI. Fistula must have been draining for at least 6 weeks prior to the inclusion.
    A complex perianal fistula is defined as a fistula that met one or more of the following criteria during its evolution:
    • High inter-sphincteric, trans-sphincteric, extra-sphincteric or supra-sphincteric.
    • Presence of ≥ 2 external openings (tracts).
    • Associated collections
    (4) Non-active or mildly active luminal CD defined by a CDAI ≤ 220.
    (5) Patients of either sex aged 18 years or older
    (6) Good general state of health according to clinical history and a physical examination.
    (7) For women of a childbearing age, they must have 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.
    *To participate in the extension follow-up period up to 52 weeks and 104 weeks, it is required the previous participation in the CX601-0302 study, having completed 24 and 52 weeks respectively. Patients should have signed the information consent for the extension follow-up period up to 52 weeks and 104 weeks.
    E.4Principal exclusion criteria
    (1) Presence of dominant luminal active Crohn’s disease requiring immediate therapy.
    (2) CDAI >220.
    (3) Concomitant rectovaginal fistulas
    (4) Patient naïve to specific treatment for perianal fistulising Crohn’s disease including antibiotics
    (5) Presence of an abscess or collections > 2 cm, unless resolved in the preparation procedure (week -3 to day 0).
    (6) Presence of > 2 internal openings.
    (7) Presence of > 3 external openings.
    (8) Rectal and/or anal stenosis and / or active proctitis, if this means a limitation for any surgical procedure.
    (9) Patient who underwent surgery for the fistula other than drainage or seton placement.
    (10) Patient with diverting stomas
    (11) Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks
    (12) Renal impairment defined by creatinine clearance below 60 ml/min calculated using Cockcroft-Gault formula or by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
    (13) Hepatic impairment defined by both of the following laboratory ranges:
    • Total bilirubin ≥ 1.5 x ULN
    • AST and ALT ≥ 2.5 x ULN
    (14) Known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
    (15) Malignant tumour or patients with a prior history of any malignant tumour, including any type of fistula carcinoma.
    (16) Current or recent history of abnormal, severe, progressive, uncontrolled hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.
    (17) Congenital or acquired immunodeficiencies.
    (18) Known allergies or hypersensivity to antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; HSA (Human Serum Albumin); DMEM (Dulbecco Modified Eagle’s Medium); materials of bovin origin; local anaesthetics or gadolinium (MRI contrast).
    (19) Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia).
    (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 previously treated with eASCs can not be enroled into this clinical study
    (25) Subjects who need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such surgery is foreseen in this region in the 24 weeks after treatment administration.
    (26) Contraindication to the anaesthetic procedure.
    E.5 End points
    E.5.1Primary end point(s)
    Remission of perianal fistulising Crohn’s disease at week 24 confirmed by MRI, defined as the clinical assessment of closure of all the external openings that were draining at baseline despite gentle finger compression at week 24, confirmed by MRI as absence of collections > 2 cm of the treated perianal fistulas at 24 weeks (central blind assessment).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    Secondary endpoints
    Efficacy analysis at week 24
    • KEY: Clinical Remission defined as closure of all treated external
    openings that were draining at baseline despite gentle finger
    compression, as clinically assessed by week 24
    • KEY: Response defined as closure of at least 50% of all treated
    external openings that were draining at baseline, as clinically assessed
    by week 24
    • Time to Clinical Remission by week 24 (defined as time from treatment
    start to first visit with closure of all treated external openings that were
    draining at baseline, as clinically assessed)
    • Time to Response by week 24 (defined as time from treatment start to
    first visit with closure of at least 50% of all treated external openings
    that were draining at baseline, as clinically assessed)
    • Relapse by week 24 defined, in patients with Clinical Remission at
    previous visit, as reopening of any of the treated external openings with
    active drainage as clinically assessed, or the development of a perianal
    collection > 2 cm of the treated perianal fistulas confirmed by centrally
    blinded MRI assessment by week 24)
    • Time to Relapse by week 24 in patients with Clinical Remission
    (defined as time from Clinical Remission to first visit with reopening of
    any of the treated external openings with active drainage as clinically
    assessed, or the development of a perianal collection > 2 cm of the
    treated perianal fistulas confirmed by centrally blinded MRI assessment
    by week 24)
    • Severity of the perianal Crohn's disease up to week 24, assessed with
    the Perianal Disease Activity Index (PDAI)
    • Quality of Life (QoL) up to week 24 assessed by the Inflammatory
    Bowel Disease Questionnaire (IBDQ)
    • CDAI score up to week 24
    • Van Assche score up to week 24
    Efficacy analysis at week 52:
    • Combined Remission of perianal fistulising Crohn's disease defined as
    the clinical assessment of closure of all the treated external openings
    that were draining at baseline
    despite gentle finger compression at week 52, and absence of collections
    > 2 cm of the treated perianal fistulas confirmed by centrally blinded
    MRI assessment by week 52
    • Clinical Remission defined as the closure of all treated external
    openings that were draining at baseline despite gentle finger
    compression, as clinically assessed at week 52
    • Response defined as closure of at least 50% of all treated external
    openings that were draining at baseline, as clinically assessed at week 52
    • Time to Combined Remission by week 52 (defined as time from
    treatment start to first visit with clinical assessment of closure of all the
    treated external openings that were draining at baseline despite gentle
    finger compression at week 52, and absence of collections > 2 cm of the
    treated perianal fistulas confirmed by centrally blinded MRI assessment
    by week 52)
    • Time to Clinical Remission by week 52 (defined as time from treatment
    start to first visit with closure of all treated external openings that were
    draining at baseline, as clinically assessed)
    • Time to Response by week 52 (defined as time from treatment start to
    first visit with closure of at least 50% of all treated external openings
    that were draining at baseline,
    as clinically assessed)
    • Relapse by week 52 in patients with Combined Remission at week 24,
    defined as reopening of any of the treated external openings with active
    drainage as clinically assessed or the development of a perianal
    collection > 2 cm of the treated perianal fistulas confirmed by centrally
    blinded MRI assessment by 52 weeks
    • Time to Relapse by week 52 in patients with Combined Remission at
    week 24 (defined as time from Combined Remission to first visit with
    reopening of any of the treated external openings with active drainage
    as clinically assessed, or the development of a perianal collection > 2 cm
    of the treated perianal fistulas confirmed by centrally blinded MRI
    assessment by week 52
    • Severity of the perianal Crohn's disease up to week 52, assessed with
    PDAI
    • Quality of Life (QoL) up to week 52 assessed by IBQD
    • CDAI score up to week 52
    • Van Assche score up to week 52
    Efficacy analysis at week 104:
    • Clinical Remission of perianal fistulising Crohn's disease defined as the
    clinical assessment of closure of all treated external openings that were
    draining at baseline despitegentle finger compression at week 104
    • Relapse by week 104 in patients with Combined Remission at week 52,
    defined as reopening of any of the treated external openings with active
    drainage as clinically assessed
    • Time to Relapse by week 104 in patients with Combined Remission at
    week 52 (defined as time from Combined Remission to first visit with
    reopening of any of the treated external openings with active drainage
    as clinically assessed)
    • Severity of the perianal Crohn's disease, assessed with PDAI up to
    week 104
    • Quality of Life (QoL) assessed by the IBQD up to week 104
    • CDAI score up to week 104
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 24, 52 and 104 weeks after the treatment
    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 No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Austria
    Belgium
    France
    Germany
    Israel
    Italy
    Netherlands
    Spain
    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
    Final study:Last visit of the last subject undergoing the trial.
    If the study is prematurely terminated or suspended for any reason, the reasons for terminating the study may include, but are not limited to the following:
    • Incidence or severity of AE indicating a potential health hazard to subjects.
    • Subject enrolment is unsatisfactory.
    • Investigator does not adhere to protocol or applicable regulatory guidelines in conducting the study.
    • Ethical or medical reasons.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 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: 139
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 208
    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)
    Medicinal Product allogenic eASCs would become available through compassionate use for placebo patients participating in the trial for the treatment of the same treated fistula, in case it remains unhealed. The patients should meet the trial inclusion and exclusion criteria at the time of the compassionate use request.
    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 Decision2012-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-30
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