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

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer
using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20
million cells. 5 patients (age 12 to 17 years) with Crohn's perianal fistulas will be
enrolled.

Subjects will undergo standard adjuvant therapy including drainage of infection and placement
of a draining seton. Six weeks post placement of the draining seton, the seton will be
replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects
will be subsequently followed for fistula response and closure for 24 months. This is an
autologous product derived from the patient and used only for the same patient.

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-aminosalicylate (5-ASA) drugs,
thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (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)