Stem cells tested for a tough Crohn's complication – but trial stopped early

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (\>2 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 subject. 3. Specific exclusions: 1. Hepatitis B or C 2. HIV 3. Abnormal AST or ALT at screening(defined as \>/= 2x ULN) 4. History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening. 5. History of colorectal cancer within 5 years. 6. Investigational drug within 30 days of treatment 7. Pregnant or breast feeding or trying to become pregnant. 8. Presence of a rectovaginal or perineal body fistula 9. Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment 10. Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment 11. Severe anal canal disease that is stenotic and requires dilation 12. Inability to wean corticosteroids 13. Unwilling to agree to use acceptable contraception methods during participation in study