Stem Cells for the Treatment of Pouchitis

Withdrawn before enrolling · Phase 1

Conditions studied: Pouchitis, Crohn's Disease, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Pouch, Ileal

In brief

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.

Key facts

Study ID

NCT05578508

Run by

The Cleveland Clinic

People needed

0

Starts

2022-04-01

Expected to finish

2024-02-01

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• HIV
• Hepatitis B or C
• Abnormal CBC at screening
• Abnormal AST or ALT at screening
• History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
• Investigational drug use within thirty (30) days of baseline
• Pregnant or breastfeeding
• Multifocal proximal small bowel involvement which resembles Crohn's of the small bowel
• Evidence of pelvic sepsis and pelvic penetrating fistulizing disease
• Patients with intestinal diversion above the level of the pouch
• Neoplasia of pouch
• Change in medical regimen for pouchitis in the two months prior to study enrollment

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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