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

Korábbi kezelés

• 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.
• Investigational drug within 30 days of treatment
• Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment
• Inability to wean corticosteroids

Más betegség

• History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
• History of colorectal cancer within 5 years.
• Presence of a rectovaginal or perineal body fistula
• 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

Laborértékek

• Specific exclusions:
  • Hepatitis B or C
  • HIV
  • Abnormal AST or ALT at screening(defined as >/= 2x ULN)

Egyéb

• Inability to give informed consent.
• Pregnant or breast feeding or trying to become pregnant.
• Unwilling to agree to use acceptable contraception methods during participation in study

• 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