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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03299413 |
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Date of registration:
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27/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease
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Scientific title:
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Ulcerative Colitis Stem Cell Therapy |
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Date of first enrolment:
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June 5, 2017 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03299413 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Jordan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Single/unmarried females or married females using two modalities of contraception for
six months after completion of the study.
- Signed informed consent.
- Patients with previous diagnosis of ulcerative colitis (UC) or newly diagnosed UC
based on endoscopic or histopathologic features
- Colitis of any activity
Exclusion Criteria:
- Mental disability that impedes adequate understanding of the study and of the
associated procedures.
- Extensive severe toxic colitis requiring admission and IV steroids or biological
treatment/surgery.
- Patients with previous colectomies.
- History of malignant disease.
- Pregnant or breastfeeding women.
- Presence of severe concomitant diseases such as chronic obstructive pulmonary disease,
Diabetes Mellitus, Cardiovascular and other autoimmune diseases.
- Positive to one or more of the infectious disease panel
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Inflammatory Bowel Diseases
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Intervention(s)
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Biological: Wharton Jelly Mesenchymal stem cells
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Primary Outcome(s)
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
[Time Frame: 6 months]
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Secondary Outcome(s)
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Evaluation of the efficacy of the injected cells (Change from Baseline in partial mayo score)
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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