Crohn's disease MedDRA version: 14.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0 Level: HLGT Classification code 10003816 Term: Autoimmune disorders System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.0 Level: PT Classification code 10064147 Term: Gastrointestinal inflammation System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0 Level: PT Cl
Conditions
Sponsors
CHU-ULg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Age between 18 and 75 years old 2-Crohn’s disease affecting terminal ileum, colon or both with diagnosis confirmed according to Lennard Jones criteria 3-Clinically active disease with a CDAI between 220 and 450 and biologically active disease with a CRP > 5 mg/l and/or fecal calprotectin > 150 microg/g 4-Resistance or intolerance to mesalazine, steroids, purine analogues, methotrexate, infliximab and adalimumab 5-Adequate venous access (central catheter or good peripheral veins) 6-Willingness to sign the informed consent and enter the clinical trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1-Any condition not fulfilling inclusion criteria 2-Indication for surgery 3-Symptomatic stricture 4-Undrained perianal or intraabdominal abscess 5-Change in mesalazine dosage within the last 4 weeks, change in steroid dosage within the last two weeks, change in immunosuppressant dosage within the last 3 months, use of anti-TNF treatment within the last two months 6-HIV positive 7-Uncontrolled infection, arrhythmia or hypertension 8-Terminal organ failure: a.Renal: anuria, serious fluid overload, GFR 3 mg/dL, and symptomatic biliary disease; d. Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia, uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and efficacy of MSC in Crohn’s disease refractory or intolerant to conventional therapies. ;Secondary Objective: Measuring outcome of Crohn's disease treated by MSC: 1.Clinical response. 2.Remission (defined by CDAI<150) 3.CDAI level 4.CRP levels 5.Fecal calprotectin levels ;Primary end point(s): To assess clinical response rate (defined by a 100 points decrease in CDAI). ;Timepoint(s) of evaluation of this end point: To assess clinical response rate (defined by a 100 points decrease in CDAI) at week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Clinical response. 2.Remission (defined by CDAI<150). 3.CDAI level at week. 4.CRP levels. 5.Fecal calprotectin levels.;Timepoint(s) of evaluation of this end point: 1.Clinical response. at week 2, 4, 8 and 12, 2.Remission (defined by CDAI<150) at week 2, 4, 8 and 12, 3.CDAI level at week 2, 4, 8 and 12, 4.CRP levels at week 2, 4, 8 and 12, 5.Fecal calprotectin levels at week 2, 4, 8 and 12. | — |
Countries
Belgium
Contacts
Public ContactYves Beguin
CHU-ULg
Outcome results
None listed