Therapeutic effect of mesenchymal cells in patients suffering from a disease characterized by a severe inflammation and/or in whom the immune system attacks their own tissues.
- Conditions
- Crohn's diseaseMedDRA version: 14.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.0Level: HLGTClassification code 10003816Term: Autoimmune disordersSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 14.0Level: PTClassification code 10064147Term: Gastrointestinal inflammationSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-005966-39-BE
- Lead Sponsor
- CHU-ULg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
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
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 < 30 ml/min, dialysis;
b.Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;
c.Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1.Clinical response. <br>2.Remission (defined by CDAI<150) <br>3.CDAI level <br>4.CRP levels <br>5.Fecal calprotectin levels ;Primary end point(s): To assess clinical response rate (defined by a 100 points decrease in CDAI).<br>;Timepoint(s) of evaluation of this end point: To assess clinical response rate (defined by a 100 points decrease in CDAI) at week 8.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Clinical response.<br>2.Remission (defined by CDAI<150). <br>3.CDAI level at week.<br>4.CRP levels. <br>5.Fecal calprotectin levels.;Timepoint(s) of evaluation of this end point: 1.Clinical response. at week 2, 4, 8 and 12, <br>2.Remission (defined by CDAI<150) at week 2, 4, 8 and 12, <br>3.CDAI level at week 2, 4, 8 and 12, <br>4.CRP levels at week 2, 4, 8 and 12, <br>5.Fecal calprotectin levels at week 2, 4, 8 and 12.<br><br>