RecruitingPhase 1Phase 2NCT03901235

MSC Intratissular Injection in Crohn Disease Patients

Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells


Sponsor

University of Liege

Enrollment

60 participants

Start Date

Jan 15, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether injecting bone marrow stem cells directly into Crohn's disease lesions in the bowel can heal areas that have not responded to standard treatments, including biologic drugs. **You may be eligible if...** - You are 18 or older with Crohn's disease diagnosed for more than 6 months - You have at least one lesion (a narrowing, deep ulcer, or draining perianal fistula) that has not responded to standard treatments including anti-TNF therapy, vedolizumab, or ustekinumab - The lesion is in a part of the bowel accessible by colonoscopy **You may NOT be eligible if...** - Your Crohn's lesions do not meet the criteria above - You have had large portions of small intestine removed (more than 40 cm) - You have a pre-existing diagnosis of chronic pancreatitis - 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.

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Interventions

BIOLOGICALMesenchymal Stromal Cells

Suspension of mesenchymal stromal cells for intratissular injection


Locations(1)

CHU de Liège

Liège, Liège, Belgium

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NCT03901235


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