Mesenchymal Stem Cells for the treatment of Crohn's Disease
Completed
- Conditions
- Crohn's Diseasede ziekte van Crohn
- Registration Number
- NL-OMON22654
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Duijvestein M, van den Brink GR, Hommes DW. Stem cells as potential novel therapeutic strategy for inflammatory bowel disease. Journal of Crohn's and Colitis (2008) 2, 99¡V106
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Men and women > 18 years of age.
2. Subject is willing to participate in the study and has signed the informed consent.
Exclusion Criteria
1. Patients with evidence of infection or abscesses.
2. Patients suffering from renal- or hepatic failure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety: rate of (serious) adverse events in the study population <br /><br>2. Feasibility: determination of the number of expanded MSCs in relation to the amount of bone marrow collected, number of passages required and time to reach study target doses.<br>
- Secondary Outcome Measures
Name Time Method 1. Induction of clinical response (reduction of CDAI > 70) or clinical remission (CDAI below 150) at six weeks.<br /><br>2. Mucosal healing (videoendoscopy with biopsies) at six weeks.<br /><br>3. Biological response (CRP reduction) at six weeks.<br>