Inflammatory Bowel Diseases Clinical Trial
Official title:
Ulcerative Colitis Stem Cell Therapy
Verified date | April 2019 |
Source | University of Jordan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Scientists hypothesize that directly or parentally injecting Mesenchymal stem cells (MSCs) to affected areas will have a positive impact through reducing or abolishing intestinal inflammation in part via inhibition of neutrophil Myeloperoxidase (MPOx) activity. Inhibiting MPOx should modify disease progression as well as reduce colitis associated cancer risk.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | January 2020 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Jordan | Cell Therapy Center | Amman |
Lead Sponsor | Collaborator |
---|---|
Hanan Jafar | Scientific Research Support fund |
Jordan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death | 6 months | |
Secondary | Evaluation of the efficacy of the injected cells (Change from Baseline in partial mayo score) | Remission will be considered if reaches 0 points and response if the score diminishes. Endoscopy will be performed at 0 and 12 weeks. | 3 months |
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