Stem Cells for the Treatment of Pouchitis

• Status: Withdrawn
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Case Western Reserve University

Criteria

Inclusion Criteria:

1. Men and women 18-75 years of age

2. Residents of the United States

3. Medically refractory pouchitis defined as lack of response to antibiotics, immunomodulators, and/or biologics

4. 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

5. No malignant or premalignant intestinal condition, ruled out on colonoscopy within 90 days of MSC delivery

6. Ability to comply with protocol

7. Competent and able to provide written informed consent

8. Must have failed or have a contraindication to standard medical therapy including anti-TNF, anti-interleukin, or anti-integrin agent

Exclusion Criteria:

1. Inability to give informed consent

2. 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

3. Specific exclusions:

• HIV

• Hepatitis B or C

• Abnormal CBC at screening

• Abnormal AST or ALT at screening

4. History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment

5. Investigational drug use within thirty (30) days of baseline

6. Pregnant or breastfeeding

7. Multifocal proximal small bowel involvement which resembles Crohn's of the small bowel

8. Evidence of pelvic sepsis and pelvic penetrating fistulizing disease

9. Patients with intestinal diversion above the level of the pouch

10. Neoplasia of pouch

11. Change in medical regimen for pouchitis in the two months prior to study enrollment