Stem Cells for the Treatment of Pouchitis (NCT05578508) | Clinical Trial Compass
WithdrawnPhase 1
Stem Cells for the Treatment of Pouchitis
Stopped: PI decision not to move forward with study.
United States0Started 2022-04
Plain-language summary
The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men and women 18-75 years of age
✓. Residents of the United States
✓. Medically refractory pouchitis defined as lack of response to antibiotics, immunomodulators, and/or biologics
✓. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF therapy, anti-integrin and anti-interleukin are permitted if have been on them for at least 2 months prior to study enrollment without change
✓. No malignant or premalignant intestinal condition, ruled out on colonoscopy within 90 days of MSC delivery
✓. Ability to comply with protocol
✓. Competent and able to provide written informed consent
✓. Must have failed or have a contraindication to standard medical therapy including anti-TNF, anti-interleukin, or anti-integrin agent
Exclusion criteria
✕. Inability to give informed consent
✕. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient
✕. Specific exclusions:
✕. History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
What they're measuring
1
Adverse Events
Timeframe: Change from Baseline over 12 months after the MSC injection
2
Healing
Timeframe: Change from Baseline over 12 months after the MSC Injection