
    fda approval was not obtained until adult trial completes accrual
  
['perianal fistula']
['only 1 arm: treatment with msc-afp']

        Inclusion Criteria

          1. Males and females 12-17 years of age.

          2. Residents of the United States.

          3. Crohn's disease with single or multiple draining complex perianal fistulae (definition
             as below) for at least three months despite standard therapy (definition below).

          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 (and assent where appropriate).

          9. Must have failed standard medical therapy including anti-TNF agents

        Exclusion Criteria

          1. Inability to obtain informed consent (and assent where appropriate).

          2. Clinically significant medical conditions within the six months before administration
             of MSCs: e.g. sepsis, pneumonia active serious infection or other conditions that
             would, in the opinion of the investigators, compromise the safety of the patient.

          3. Specific exclusions;

             a. 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 trying to become 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. If adipose tissue is not technically feasible

         11. Weight less than 35 kg

         12. Allergic to local anesthetics

         13. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)
      