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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06317818
Other study ID # TJT2301
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 6, 2023
Est. completion date August 2025

Study information

Verified date March 2024
Source Centre Hospitalier Universitaire de Liege
Contact Sophie Vieujean, MD
Phone +32 4 323.72.56
Email s.vieujean@chuliege.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mesenchymal Stem Cells
Suspension of mesenchymal stromal cells for intratissular injection
Comparative placebo
Cell-free cell suspension solution devoid of cells for intratissular injection

Locations

Country Name City State
Belgium CHU de Liège Liège

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease. Recording of occurrence of adverse events (serious or not) up to week 48 From Week 0 to Week 48
Primary Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating symptomatic clinical response The symptomatic clinical response will be assessed by a composite score, calculated over an average of 7 days, taking up 2 of the 16 questions of the S-PRO or Stenosis Patient Reported Outcome in English (also called Stricturing Crohn's Disease Questionnaire). A score for postprandial abdominal pain < 2 and an average score, out of 7 days, for amount of types of food <2 also. Between Week 0, Week 24 and Week 48
Primary Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating endoscopic response The endoscopic response will be defined by the ability to pass an adult colonoscope (complete endoscopic response) or an increase in lumen diameter (partial endoscopic response) measured in comparison with the size of an open biopsy forceps (7mm) Between Week 0, Week 24 and Week 48
Primary Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating radiological response The radiological response will be defined by the presence of 3 of the 4 following criteria: (1) an improvement in luminal narrowing (improvement greater than 50% and/or reduction in luminal diameter of less than 50%); (2) improvement in pre-stenotic dilation (pre-stenotic dilation reduced by 50%, bowel diameter equal to normal bowel and/or pre-stenotic dilation improved to less than 2.5 cm); (3) reduction in wall thickening (50% improvement in gut wall thickening); (4) a reduction in the length of the stricture (50% improvement) Between Week 0, Week 24 and Week 48
Secondary Evaluation of studying, in addition to biomarkers (CRP and fecal calprotectin), Evaluation of evolution of biomarkers (CRP and fecal calprotectin) over the time by blood and stool samples analysis Weeks 0, 4, 12, 24, 36 and 48
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