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    Summary
    EudraCT Number:2011-006064-43
    Sponsor's Protocol Code Number:Cx601-0302
    National Competent Authority:Italy - Italian Medicines Agency
    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 ConcernedItaly - Italian Medicines Agency
    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. ADMIRE-CD study.
    Studio di fase III multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo per valutare l'efficacia e la sicurezza delle cellule staminali allogeniche espanse derivate dal tessuto adiposo (eASCs) per il trattamento della malattia di Crohn fistolizzante perianale della durata di 24 settimane. Studio ADMIRE-CD.
    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
    Studio per valutare l'efficacia e la sicurezza delle cellule staminali allogeniche derivate dal tessuto adiposo per il trattamento delle fistole perianali nei pazienti con malattia di Crohn
    A.3.2Name or abbreviated title of the trial where available
    ADIMIRE-CD study
    Studio ADMIRE-CD
    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 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 supportCELLERIX, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCELLERIX, S.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressC/Marconi, 1 Parque Tecnologico de Madrid
    B.5.3.2Town/ cityTres Cantos. Madrid
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 804 9264
    B.5.5Fax number+34 91 804 9263
    B.5.6E-maillydia.dorrego@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 milion 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAllogenic eASCs
    D.3.9.3Other descriptive nameExpanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs)
    D.3.9.4EV Substance CodeNA
    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) No
    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
    Malattia di Crohn fistolizzante perianale
    E.1.1.1Medical condition in easily understood language
    Treatment for perianal fistulising Crohn's disease
    Trattamento per le fistole anali della malattia di Crohn
    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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 fistulising Crohn’s disease over a 24-week period.
    Valutare l’efficacia e la sicurezza delle eASCs rispetto al placebo per il trattamento della malattia di Crohn fistolizzante per un periodo di 24 settimane.
    E.2.2Secondary objectives of the trial
    There are not secondary objectives
    Non ci sono obiettivi secondari
    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 fistulas (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.
    1-Consenso informato firmato
    2-Pazienti con malattia di Crohn (CD) diagnosticata almeno 6 mesi prima in conformità ai criteri clinici, endoscopici, istologici e/o radiologici accettati.
    3-Presenza di fistole perianali complesse con un massimo di 2 fistole (orifizi interni) e un massimo di 3 orifizi esterni, accertate con valutazione clinica e MRI. La fistola deve avere drenato per almeno 6 settimane prima dell’inclusione nello studio. Una fistola perianale complessa è definita come una fistola che ha soddisfatto uno o più dei seguenti criteri durante la sua evoluzione:
    •Alta intrasfinterica, transfinterica, extrasfinterica o soprasfinterica.
    •Presenza di 2 o più orifizi esterni (tratti).
    •Collezioni associate.
    4-CD luminale non attiva o lievemente attiva definita da un CDAI ≤ 220.
    5-Pazienti di entrambi i sessi di età pari o superiore a 18 anni.
    6-Stato generale di salute buono in base ad anamnesi clinica e visita medica.
    7-Le donne in età fertile devono avere un test di gravidanza su siero o urine negativo (sensibilità 25 UI di gonadotropina corionica umana [hCG]). Sia gli uomini che le donne devono utilizzare opportuni metodi di controllo delle nascite stabiliti dallo sperimentatore.
    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 fistular lesions.
    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-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. 25-Contraindication to the anaesthetic procedure.
    1-Presenza di malattia di Crohn luminale attiva dominante che richiede terapia immediata.
    2-CDAI &gt;220.
    3-Fistole rettovaginali concomitanti. 4-Paziente naïve a trattamento specifico per la malattia di Crohn fistolizzante perianale, compresi gli antibiotici.
    5-Presenza di ascesso o collezioni &gt; di 2 cm, salvo risoluzione nella procedura di preparazione (dalla settimana -3 al giorno 0).
    6-Presenza di più di 2 lesioni fistolari.
    7-Presenza di più di 3 orifizi esterni.
    8-Stenosi rettale e/o anale e/o proctite attiva, se questo rappresenta un limite per eventuale intervento chirurgico.
    9-Pazienti che sono stati sottoposti a intervento chirurgico per la fistola diverso da drenaggio o posizionamento di setone.
    10-Pazienti con stomi diverticolari. 11-Pazienti con trattamento a base di steroidi in corso o trattati con steroidi nelle ultime 4 settimane.
    12-Insufficienza renale definita da clearance della creatinina inferiore a 60 ml/min calcolata utilizzando la formula Cockcroft-Gault o mediante creatinina sierica &gt; 1,5 volte il limite superiore dell’intervallo di normalità (ULN).
    13-Insufficienza epatica definita da entrambi i seguenti intervalli di laboratorio:
    •Bilirubina totale ≥ 1,5 volte l’ULN.
    •AST e ALT ≥ 2,5 volte l’ULN.
    14-Storia nota di abuso di alcol o altre sostanze che danno dipendenza nei 6 mesi precedenti l’inclusione. 15-Tumore maligno o pazienti con una precedente anamnesi di tumore maligno, incluso qualsiasi tipo di carcinoma da fistola.
    16-Anamnesi attuale o recente di disturbo anomalo, grave, progressivo, non controllato di tipo epatico, ematologico, gastrointestinale (tranne CD), endocrino, polmonare, cardiaco, neurologico, psichiatrico o cerebrale.
    17-Immunodeficienze congenite o acquisite.
    18-Allergie note o ipersensibilità agli antibiotici, comprese, tra l'altro, penicillina, streptomicina, gentamicina, aminoglicosidi; HSA (albumina di siero umana); DMEM (Mezzo di coltura di Dulbecco modificato); materiali di origine bovina; anestetici locali o gadolinio (contrasto per MRI).
    19-Controindicazioni per la scansione della MRI (per esempio, per la presenza di pacemaker, protesi all’anca o grave claustrofobia).
    20-Intervento chirurgico importante o grave trauma nei 6 mesi precedenti. 21-Donne in gravidanza o che allattano al seno.
    22-Pazienti che non desiderano o non possono soddisfare le procedure dello studio.
    23-Pazienti che attualmente ricevono o hanno ricevuto nei 3 mesi precedenti l’arruolamento nel presente studio clinico qualsiasi farmaco sperimentale.
    24-Soggetti che necessitano di intervento chirurgico nella regione perianale per motivi diversi dalle fistole al momento dell’inclusione nello studio o per i quali tale intervento chirurgico è previsto in questa regione nelle 24 settimane successive alla somministrazione del trattamento.
    25-Controindicazione all’anestesia.
    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).
    Remissione della malattia di Crohn fistolizzante perianale alla settimana 24 confermata da MRI, definita come la valutazione clinica della chiusura di tutti gli orifizi esterni che stavano drenando alla baseline malgrado lieve compressione con le dita alla settimana 24, confermata da MRI come assenza di collezioni > di 2 cm delle fistole perianali trattate alla settimana 24 (valutazione in cieco centrale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 settimane
    E.5.2Secondary end point(s)
    Efficacy • Response, defined as closure of at least 50% of all external openings that were draining at baseline. • Time to remission, (first visit with closure of all external openings that were draining at baseline, as clinically assessed). • Time to response (first visit with closure of at least 50% of all external openings that were draining at baseline, as clinically assessed). • Severity of the perianal Crohn’s disease, assessed with the Perianal Disease Activity Index (PDAI). • Quality of Life (QoL) assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ). Safety: • Adverse events • Physical examination • Vital signs • Laboratory tests (biochemistry, haematology, urinalysis) • CDAI score
    Efficacia: • Risposta definita come chiusura di almeno il 50% di tutti gli orifizi esterni che stavano drenando alla baseline. • Tempo alla remissione (prima visita con chiusura di tutti gli orifizi esterni che stavano drenando alla baseline, secondo quanto valutato clinicamente). • Tempo alla risposta (prima visita con chiusura di almeno il 50% di tutti gli orifizi esterni che stavano drenando alla baseline, secondo quanto valutato clinicamente). • Gravità della malattia di Crohn perianale, valutata con l’indice di attività della malattia perianale (PDAI). • Qualità della vita (QoL) valutata dal questionario sulla qualità della vita di pazienti con malattie infiammatorie dell’intestino (IBDQ). Sicurezza: • Eventi avversi • Visita medica • Segni vitali • Esami di laboratorio (biochimica, ematologia, analisi delle urine) • Punteggio CDAI
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6, 12, 18 and 24 weeks after the treatment.
    A 6, 12, 18 e 24 settimane dal trattamento
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Israel
    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 last subject undergoing the trial. If the study is prematurely terminated , the reasons may include: -severity of AE. -Enrollment is unsatisfactory. -Investigator does not adhere to Protocol or applicable regulatory guidelines in conducting the study - Ethical or medical reasons.
    Fine dello studio: ultima visita dell'ultimo soggetto in sperimentazione. In caso di chiusura anticipata le motivazioni possono essere: -gravità degli AE -arruolamento insoddisfacente -mananza di adesione al Protocollo -motivi etici o medici
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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.1.1Number of subjects for this age range: 0
    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 state50
    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)
    Compasive use
    Uso compassionevole
    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 Decision2012-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
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