Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Di… (NCT04519697) | Clinical Trial Compass
TerminatedPhase 1/2
Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease
Stopped: PI left Cleveland Clinic
United States20 participantsStarted 2020-10-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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 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 subject.