Crohn's disease
Conditions
Brief summary
The occurrence of adverse events (serious or not) up to week 48 for safety evaluation, A clinical response to symptomatic stricture WITH either an endoscopic response or a radiological response AND the absence of recourse to endoscopic dilation, surgery, corticosteroid therapy or therapeutic optimization of anti-inflammatory treatment currently used for Crohn's Disease at the time of the procedure, for efficacy, for primary efficacy evaluation
Detailed description
Evolution of Patient Reported Outcomes (PROs) and Stenosis Patient Reported Outcomes (S-PROs) between weeks 0, 24 and 48, as well as the evolution of endoscopic and radiological parameters (measured by DCE-MRI) between weeks 0, 24 and 48, for secondary efficacy evaluation.
Interventions
DRUGMSC
DRUGThe placebo will be the administration buffer of the MSCs
DRUGcomposed of 75% NaCL 0.9% and 25% HSA 20% (Human serum albumin). The placebo will be administred as a sigle local injection
Sponsors
Centre hospitalier universitaire de Liege
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of adverse events (serious or not) up to week 48 for safety evaluation, A clinical response to symptomatic stricture WITH either an endoscopic response or a radiological response AND the absence of recourse to endoscopic dilation, surgery, corticosteroid therapy or therapeutic optimization of anti-inflammatory treatment currently used for Crohn's Disease at the time of the procedure, for efficacy, for primary efficacy evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of Patient Reported Outcomes (PROs) and Stenosis Patient Reported Outcomes (S-PROs) between weeks 0, 24 and 48, as well as the evolution of endoscopic and radiological parameters (measured by DCE-MRI) between weeks 0, 24 and 48, for secondary efficacy evaluation. | — |
Countries
Belgium
Outcome results
None listed