Local injection of stem cells after endoscopic dilation for Crohn's disease
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?
This study is testing if injecting stem cells into the intestines after a procedure can help people with Crohn's disease and narrow intestinal passages feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 1 site (Liège) |
| Trial ID | NCT06317818 on ClinicalTrials.gov |
What this trial studies
This exploratory phase II study evaluates the safety and efficacy of local injections of mesenchymal stem cells (MSCs) in patients with symptomatic intestinal strictures due to Crohn's disease. Participants will receive either the MSC treatment combined with endoscopic dilation or a placebo, allowing for a comparison of outcomes. The study aims to determine if this combined approach can improve the management of strictures in these patients. Eligible patients must have a specific type of stricture that meets defined radiological criteria and be experiencing symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Crohn's disease and symptomatic intestinal strictures eligible for endoscopic dilation.
Not a fit: Patients with strictures that are passable by ileo-colonoscopy or those not meeting the specific radiological criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of intestinal strictures in Crohn's disease patients, potentially reducing symptoms and the need for surgical interventions.
How similar studies have performed: While the use of mesenchymal stem cells in gastrointestinal conditions is being explored, this specific approach combining MSCs with endoscopic dilation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 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 entero-MRI or to the use of contrast product injection in entero-MRI (Gadolinium) * Pregnant woman or planning a pregnancy in the year * Patient with kidney insufficiency (with anuria, 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.
Where this trial is running
Liège
- CHU de Liège — Liège, Belgium (Recruiting)
Study contacts
- Study coordinator: Sophie Vieujean, MD
- Email: s.vieujean@chuliege.be
- Phone: +32 4 323.72.56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.