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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Suspension of mesenchymal stromal cells for intratissular injection
Cell-free cell suspension solution devoid of cells for intratissular injection
CHU de Liège
Liège, Belgium
RECRUITINGAssessment 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
Time frame: From Week 0 to Week 48
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.
Time frame: Between Week 0, Week 24 and Week 48
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)
Time frame: Between Week 0, Week 24 and Week 48
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)
Time frame: Between Week 0, Week 24 and Week 48
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
Time frame: Weeks 0, 4, 12, 24, 36 and 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.