Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation
Conditions
Interventions
Product Name: Mesenchymal Stem Cells
Product Code: MSC
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo
Sponsors
CHU of Liège
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease.;Secondary Objective: - 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.;Primary 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;Timepoint(s) of evaluation of this end point: At Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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.;Timepoint(s) of evaluation of this end point: At Week 24 and 48 | — |
Countries
Belgium
Contacts
Public ContactPrincipal Investigator
CHU of Liège
Outcome results
None listed