A Phase 1/2 interventional study of Mesenchymal Stromal Cells in Efficacy and Safety, sponsored by University of Liege. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by University of Liege · Phase 1/2, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Mesenchymal Stromal Cells
Suspension of mesenchymal stromal cells for intratissular injection
Proportion of patients with deep ulcer healing
Complete deep ulcer healing is defined by the disappearance of the ulcer; partial healing is defined by a decrease in the depth or the diameter of the ulcer.
Time frame: Week 12
Proportion of patients with stricture healing
Complete stricture healing is defined by the ability to pass the ileocolonoscope through the stricture; partial healing is defined by the increase in the diameter of the stricture.
Time frame: Week 12
Proportion of patients with complex perianal fistula healing
Complete complex perianal fistula healing is defined by the complete closure of the external fistula opening, no drainage upon gentle pressure, no abscess. And by looking at the size of the fistulous track, presence of collection, and gadolinium enhancement by MRI
Time frame: Week 12
Safety assessed by the incidence of treatment-emergent adverse events during the study period
Assessment of the incidence of adverse and serious adverse events over the 48 weeks study period. Toxicity grade of adverse events is determined using the Common Terminology Criteria for Adverse Events (version 4.0). Relationship to the therapeutic procedure will systematically be assessed.
Time frame: from week 0 to week 48
Evolution of clinical disease activity index
Assess disease activity in Crohn's disease over 7 days using the Crohn's disease activity index
Time frame: week 0, 12 and 48
Evolution of Short health scale (quality of life)
min : 0 - max : 10 (worse)
Time frame: week 0, 12 and 48
Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease)
which incorporates clinical, surgical, endoscopic, and imaging findings from all segments of the digestive tract into one composite score
Time frame: week 0, 12 and 48
Evolution of the " Group of Therapeutic Study of Inflammatory Disorders of the Digestive Tube" obstructive score for Crohn Disease strictures
Grade : from 0 to higher value 6
Time frame: weeks 0, 12 and 48
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University of Liege