Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Approximately 10% of all female Crohn's patients have a rectovaginal fistula. Rectovaginal fistulas cause air, stool, and/or drainage per vagina and may be associated with pain, recurrent urinary tract infections and diminished quality of life. Conventional therapy includes immunosuppressive medications used to treat Crohn's disease and various surgical interventions. However, all have limited ability to heal these fistulas. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with rectovaginal fistulas in the setting of Crohn's disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amy Lightner; The Cleveland Clinic

Criteria

Inclusion Criteria:

1. Females 18-75 years of age with a diagnosis of Crohn's disease for at least six months duration.

2. Single-tract, rectovaginal fistula in the setting of Crohn's disease.

3. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia

4. Ability to comply with protocol

5. Competent and able to provide written informed consent, and ability to comply with protocol

6. Concurrent Crohn's related therapies with stable doses (>3 months) corticosteroids, 5-ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin are permitted

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:

1. Hepatitis B or C

2. HIV

3. Abnormal AST or ALT at screening

4. History of cancer including melanoma (with the exception of localized skin cancers) in the past five years

5. Investigational drug within one year of treatment

6. Pregnant or breast feeding or trying to become pregnant.

7. Presence of a rectovaginal or perineal body fistula

8. Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment

9. Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment

10. Severe anal canal disease that is stenotic and requires dilation

11. Inability to wean corticosteroids

12. Unwilling to agree to use acceptable contraception methods during participation in study

13. Known allergy to DMSO solution