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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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:2022-003833-21
    Sponsor's Protocol Code Number:TJT2301
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2022-003833-21
    A.3Full title of the trial
    Is local injection of mesenchymal stem cells after endoscopic dilation safe and does it improve the outcome of intestinal stricture in patients with Crohn's disease?
    L’injection locale de cellules souches mésenchymateuses après dilatation endoscopique est-elle sure et améliore-t-elle le devenir des sténoses intestinales chez les patients atteints de maladie de Crohn ?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is local injection of mesenchymal stem cells after endoscopic dilation safe and does it improve the outcome of intestinal stricture in patients with Crohn's disease?
    L’injection locale de cellules souches mésenchymateuses après dilatation endoscopique est-elle sure et améliore-t-elle le devenir des sténoses intestinales chez les patients atteints de maladie de Crohn ?
    A.4.1Sponsor's protocol code numberTJT2301
    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 SponsorCHU of Liège
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU of Liège
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU of Liège
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de l'Hôpital, 1
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3243237256
    B.5.5Fax number3243237889
    B.5.6E-mails.vieujean@chuliege.be
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMesenchymal Stem Cells
    D.3.2Product code MSC
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubmucosal use
    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 placeboSubmucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation
    Patients atteints de maladie de Crohn avec sténose intestinale symptomatique, éligible à une dilatation endoscopique
    E.1.1.1Medical condition in easily understood language
    Crohn's disease patients
    Patients atteints de maladie de Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease.
    Evaluer la sécurité et l’efficacité de l’injection locale de CSMs, en association à une dilatation endoscopique, dans les sténoses de patients atteints de maladie de Crohn.
    E.2.2Secondary objectives of the trial
    - To identify the predictive factors of a clinical response to this combined treatment.
    - To evaluate the histological modifications of the proteome of the intestinal epithelium, of the adherent intestinal microbiota, the serum/plasma proteomic profile and the blood immunophenotyping, induced by these MSCs, to better understand the specific mechanisms of action of this treatment.
    - D’identifier les facteurs prédictifs d’une réponse clinique à ce traitement combiné.
    - D’évaluer les modifications histologiques, du protéome de l’épithélium intestinal, du microbiote intestinal adhérent, du profil protéomique du sérum/plasma et de l’immunophénotypage sanguin, induites par ces CSMs, pour tenter de mieux comprendre les mécanismes d'action spécifiques de ce traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient aged ≥ 18 years with Crohn's Disease diagnosed more than 6 months ago
    - Background treatment, for Crohn's Disease, stable for 4 months
    - Presence of stricture (whether de novo or anastomotic), meeting the radiological definition of stenosis, i.e. a combination of the following criteria: (1) localized luminal narrowing (reduction of luminal diameter by at least less than 50% compared to adjacent healthy bowel segment), (2) bowel wall thickening (25% increase in wall thickness compared to adjacent unaffected bowel) and pre-stenotic dilation (luminal diameter greater than 3 cm)
    - Presence of symptomatic stricture with abdominal pain after meals and limitations on the amount or type of food at screening
    - Presence of a stenosis accessible by ileo-colonoscopy, not passable (i.e. not allowing the passage of the adult ileo-colonoscope), of a length less than 5 cm, eligible for endoscopic dilation
    - Patient accepting the study protocol and having signed an informed consent
    - Patient capable of undergoing entero-MRI
    - Patient âgé de ≥ 18 ans atteint d’une maladie de Crohn diagnostiquée il y a plus de 6 mois
    - Traitement de fond, pour la maladie de Crohn, stable depuis 4 mois
    - Présence d’une sténose (qu’elle soit de novo ou anastomotique), répondant à la définition radiologique d’une sténose, à savoir une combinaison des critères suivants : (1) un rétrécissement luminal localisé (réduction du diamètre luminal d'au moins 50 % par rapport à l’intestin adjacent sain), (2) un épaississement de la paroi intestinale (augmentation de l'épaisseur de la paroi de 25 % par rapport à l'intestin adjacent non affecté) et une dilatation pré-sténotique (diamètre luminal supérieur à 3 cm)
    - Présence d’une sténose symptomatique avec douleurs abdominales après les repas et limitations pour la quantité ou le type de nourriture au screening
    - Présence d’une sténose accessible par iléo-coloscopie, non franchissable (c’est-à-dire ne permettant pas le passage de l’iléo-colonoscope), d'une longueur inférieure à 5 cm, éligible à une dilatation endoscopique
    - Patient acceptant le protocole d’étude et ayant signé un consentement éclairé
    - Patient capable de subir une entéro-IRM
    E.4Principal exclusion criteria
    - Patient liable for immediate surgery
    - Patient with intra-abdominal fistula or abscess
    - Patient with a stenosis not accessible to ileocolonoscopy
    - Patient presenting ≥ 2 strictures with impossibility of determining which stenosis is "dominant" and responsible for the symptoms (based on dilation in entero-MRI)
    - Patient with a stenosis longer than 5 cm
    - Patient with a contraindication to performing an MRE or to the use of contrast product injection in MRE (Gadolinium)
    - Pregnant woman or planning a pregnancy in the year
    - Patient with kidney insufficiency (with anuria, GFR or glomerular filtration rate < 30 ml/min or on dialysis), hepatic insufficiency (presence of fulminant hepatitis, cirrhosis with signs of portal hypertension , acute alcoholic hepatitis, esophageal varices, history of gastrointestinal bleeding following rupture of esophageal varices, hepatic encephalopathy, prolonged prothrombin time, ascites secondary to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with a total serum bilirubin level > 3 mg/dL)
    - Patient with documented human immunodeficiency virus (HIV) infection, active hepatitis B or C or tuberculosis
    - Patient having presented an opportunistic infection in the 6 months preceding inclusion or a serious infection in the previous 3 months
    - Patient who has developed a malignant tumor with a history of lymphoproliferative disease with the exception of: non-melanoma skin cancer, carcinoma in situ (e.g. skin, cervix, bladder, breast) and in remission for at least 3 years prior to screening, superficial bladder cancer, asymptomatic low-grade or localized curatively treated prostate cancer for which the “watch-and-wait” approach is the standard of care as well as any other cancer that has been in remission for ≥ 3 years prior to enrollment.
    - Patient redevable d’une intervention chirurgicale immédiate
    - Patient présentant une fistule ou un abcès intra-abdominal
    - Patient porteur d’une sténose non-accessible à l'iléo-coloscopie
    - Patient présentant ≥ 2 sténoses avec impossibilité de déterminer quelle sténose est « dominante » (sur base de la dilatation en entéro-IRM)
    - Patient présentant une sténose d’une longueur supérieure à 5 cm
    - Patient présentant une contre-indication à la réalisation d’une entéro-IRM ou à l’injection de produit de contraste utilisé en entéro-IRM (Gadolinium)
    - Femme enceinte ou envisageant une grossesse dans l'année
    - Patient atteint d’une insuffisance rénale (avec anurie, GFR ou taux de filtration glomérulaire < 30 ml/min ou dialysé), d’une insuffisance hépatique (présence d’une hépatite fulminante, d’une cirrhose avec signes d'hypertension portale, d’une hépatite alcoolique aiguë, de varices œsophagiennes, d’antécédents d’hémorragie digestive sur rupture de varices œsophagiennes, d’encéphalopathie hépatique, d’un allongement du temps de prothrombine, d’ascite secondaire à une hypertension portale, d’abcès hépatique bactérien ou fongique, d’une obstruction biliaire, d’une hépatite virale chronique avec un taux de bilirubine sérique totale > 3 mg/dL)
    - Patient atteint d’une infection documentée par le virus de l'immunodéficience humaine (VIH), d’une hépatite B ou C active ou d’une tuberculose
    - Patient ayant présenté une infection opportuniste dans les 6 mois précédant l’inclusion ou une infection grave dans les 3 mois précédents
    - Patient ayant développé une tumeur maligne porteur d’un antécédent de maladie lymphoproliférative à l’exception : du cancer de la peau non mélanique, du carcinome in situ (par ex : de la peau, du col, de la vessie, du sein) et en rémission depuis au moins 3 ans avant le screening, du cancer de la vessie superficiel, du cancer de la prostate asymptomatique de bas grade ou localisé traité de manière curative pour lequel l'approche « watch-and-wait » est le standard de soins ainsi que tout autre cancer qui est en rémission depuis ≥ 3 ans avant l’enrôlement.
    E.5 End points
    E.5.1Primary end point(s)
    A clinical response to the symptomatic stenosis at week 48 associated with either an endoscopic response or a radiological response AND an absence of further endoscopic dilation, surgical management for the stenosis or optimization of drug treatment or use of corticosteroid therapy
    Une réponse clinique à la sténose symptomatique à la semaine 48 associée à soit une réponse endoscopique soit une réponse radiologique ET une absence de nouvelle dilatation endoscopique, de prise en charge chirurgicale pour la sténose ou d’optimisation du traitement médicamenteux ou de recours à une corticothérapie
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 48
    A la semaine 48
    E.5.2Secondary end point(s)
    - The favorable evolution of clinical scores (PRO, CDOS, CDAI, SHS and S-PRO) between follow-up visits
    - The complete or partial endoscopic response of the stricture, assessed by ileo-colonoscopy, at 24 weeks
    - Improvement of the stenosis, during reassessment by DCE-MRI (lumen size, parietal thickness, pre-stenotic dilation and length of the stricture) between weeks 0, 24 and 48
    - The evolution of the CDEIS over time
    - The evolution of biomarkers (CRP, faecal calprotectin) over time
    - The time before a symptomatic, endoscopic and radiological clinical relapse
    - The need for a new intervention (endoscopic dilation, recourse to surgery, introduction of corticosteroid therapy or therapeutic optimization) at week 48.
    - L’évolution favorable des scores cliniques (PRO, CDOS, CDAI, SHS et S-PRO) entre les visites de suivi
    - La réponse endoscopique complète ou partielle de la sténose, évaluée par iléo-colonoscopie, à 24 semaines
    - L’amélioration de la sténose, lors de la réévaluation par entéro-IRM (calibre de la lumière, épaisseur pariétale, dilatation pré-sténotique et longueur de la sténose) entre les semaines 0, 24 et 48
    - L’évolution du CDEIS au cours du temps
    - L’évolution des biomarqueurs (CRP, calprotectine fécale) au cours du temps
    - Le délai avant une rechute clinique symptomatique, endoscopique et radiologique
    - Le besoin de réintervention (dilatation endoscopique, recours à la chirurgie, introduction d’une corticothérapie ou optimisation thérapeutique) à la semaine 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Week 24 and 48
    Aux semaines 24 et 48
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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.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)
    None
    Aucun
    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 Decision2023-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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