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

What this Trial Is About

Researchers are evaluating the use of local injections of mesenchymal stromal cells (MSC) to help heal difficult-to-treat intestinal and perianal lesions in people with Crohn's disease. This trial focuses on both how well the MSC injections promote healing and the safety of this treatment. The study is conducted by the University of Liege and includes patients with Crohn's disease lesions that have not responded to standard therapies, including immunosuppressants and biologic drugs. Participants receive injections of a suspension containing mesenchymal stromal cells directly into the affected tissues. The study includes three groups of 20 patients each, categorized by the type of lesion: strictures of the colon or ileum, deep ulcers in the colon or ileum, and actively draining perianal fistulas. The treatment is given locally to target these refractory lesions, with no placebo group or blinding involved. During the study, participants will be monitored up to 48 weeks for healing outcomes at 12 weeks, including deep ulcer healing, stricture healing, and fistula healing. Safety is assessed by tracking any treatment-related side effects throughout the study period. Additional assessments include disease activity, quality of life, intestinal damage, and obstruction scores measured at the start, 12 weeks, and 48 weeks. The goal is to understand the healing effects of MSC injections and their safety profile for people with Crohn's disease who have lesions resistant to other treatments.

MSC Intratissular Injection in Crohn Disease Patients