Status:
UNKNOWN
Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease
Lead Sponsor:
Amy Lightner
Conditions:
Rectovaginal Fistula
Crohn Disease
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 trac...
Detailed Description
This study is designed to determine the safety and efficacy of direct injection of adult allogeneic bone marrow derived mesenchymal stem cells for the treatment of rectovaginal fistulas in the setting...
Eligibility Criteria
Inclusion
- Females 18-75 years of age with a diagnosis of Crohn's disease for at least six months duration.
- Single-tract, rectovaginal fistula in the setting of Crohn's disease.
- Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
- Ability to comply with protocol
- Competent and able to provide written informed consent, and ability to comply with protocol
- Concurrent Crohn's related therapies with stable doses (\>2 months) corticosteroids, 5-ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin are permitted
Exclusion
- 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 subject.
- Specific exclusions:
- Hepatitis B or C
- HIV
- Abnormal AST or ALT at screening(defined as \>/= 2x ULN)
- History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
- History of colorectal cancer within 5 years.
- Investigational drug within 30 days of treatment
- Pregnant or breast feeding or trying to become pregnant.
- Presence of a rectovaginal or perineal body fistula
- Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment
- Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment
- Severe anal canal disease that is stenotic and requires dilation
- Inability to wean corticosteroids
- Unwilling to agree to use acceptable contraception methods during participation in study
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04519697
Start Date
October 28 2020
End Date
October 1 2022
Last Update
April 5 2022
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195