Ensayos clínicos

Inclusion Criteria

1. Females 18-65 years of age.
2. Residents of the United States.
3. Crohn's disease with single or multiple draining complex rectovaginal fistulae for at least three months despite standard therapy
4. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
5. All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
6. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
7. Ability to comply with protocol
8. Competent and able to provide written informed consent
9. Must have failed standard medical therapy including anti-TNF agents
10. Currently with diverting ileostomy or accepting of diverting ileostomy at time of stem cell loaded plug placement.

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; Evidence of hepatitis B, C, or HIV
4. History of cancer including melanoma (with the exception of localized skin cancers)
5. Investigational drug within thirty (30) days of baseline
6. A resident outside the United States
7. Pregnant or breast feeding.
8. History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
9. Previous allergic reaction to a perianal fistula plug.
10. Allergic to local anesthetics
11. Pregnant patients or trying to become pregnant.
12. entero-vesicular or multiple concurrent perianal tracts