RecruitingPhase 2NCT06317818

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?


Sponsor

Centre Hospitalier Universitaire de Liege

Enrollment

50 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether injecting stem cells (mesenchymal stem cells) directly into a narrowed section of the intestine — right after stretching it open with a procedure called endoscopic dilation — can help prevent the narrowing from coming back in patients with Crohn's disease. **You may be eligible if...** - You are 18 years or older and have had Crohn's disease for more than 6 months - Your medication for Crohn's disease has been stable for the past 4 months - You have an intestinal narrowing (stricture) that can be seen on imaging and causes symptoms like pain after eating - The narrowing is accessible via colonoscopy and short enough to treat **You may NOT be eligible if...** - You have a stricture longer than 5 cm, or multiple strictures, or one with a suspected cancer - You have an active abscess or fistula near the stricture - You have certain other serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERMesenchymal Stem Cells

Suspension of mesenchymal stromal cells for intratissular injection

OTHERComparative placebo

Cell-free cell suspension solution devoid of cells for intratissular injection


Locations(1)

CHU de Liège

Liège, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06317818


Related Trials