Mesenchymal stromal cell therapy for the treatment of proctitis in ulcerative colitis
- Conditions
- lcerative ColitisColitis UlcerosaInflammatory Bowel Diseases
- Registration Number
- NL-OMON21802
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
a)Men and women ≥ 18 years of age;
b)Patient must have UC confirmed by endoscopic and histologic evidence;
Exclusion Criteria
a)Patients suffering from renal- or hepatic failure;
b)Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety and tolerability of endoscopic injected MSCs in the distal colon of patients with refractory proctitis after 6 weeks.
- Secondary Outcome Measures
Name Time Method 1.To assess changes in the Mayo Score (appendix C) before and after BMMSC treatment; as an indication of efficacy.<br /><br>2.To assess changes in patient-reported outcome measures (PROMs) using the mHealth index (appendix D) [71].<br /><br>3.To summarize the changes in serum c-reactive protein (CRP) and fecal calprotectin.<br /><br>4.To compare histologic disease activity before and after local BMMSC treatment using the Geboes score (appendix E).<br /><br>5.To evaluate the effects of this intervention on immunological parameters and local MSC persistence.<br /><br>6.To evaluate the effect of local treatment with allogeneic BMMSCs on the quality of life using the 12-item Short Form Health Survey (SF-36) (appendix F) and the short Inflammatory Bowel Disease Questionnaire (sIBDQ) (appendix G).<br>