EUCTR2011-005966-39-BE
Active, not recruiting
Not Applicable
Mesenchymal stem cell therapy for the treatment of severe or refractory inflammatory and/or autoimmune disorders.
CHU-ULg0 sites20 target enrollmentDecember 12, 2011
ConditionsCrohn'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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn's disease
- Sponsor
- CHU-ULg
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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 \< 30 ml/min, dialysis;
- •b.Pulmonary: DLCO \< 35% and/or receiving supplementary continuous oxygen;
Outcomes
Primary Outcomes
Not specified
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