Pediatric MSC-AFP Sub-study for Crohn's Fistula

Prior treatment

• 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.
• Investigational drug within thirty (30) days of baseline
• History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
• Previous allergic reaction to a perianal fistula plug.

Other illness

• Specific exclusions;
  • Evidence of hepatitis B, C, or HIV
• History of cancer including melanoma (with the exception of localized skin cancers)
• Allergic to local anesthetics

Other

• Inability to obtain informed consent (and assent where appropriate).
• A resident outside the United States
• Pregnant or trying to become pregnant, or breast feeding.
• If adipose tissue is not technically feasible
• Weight less than 35 kg
• Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)

• Males and females 12-17 years of age.
• Residents of the United States.
• Crohn's disease with single or multiple draining complex perianal fistulae (definition as below) for at least three months despite standard therapy (definition below).
• Concurrent therapies with corticosteroids, 5-aminosalicylate (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted.
• All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
• 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 assent where appropriate).
• Must have failed standard medical therapy including anti-TNF agents