Stem Cell Coated Fistula Plug in Patients With Crohn's RVF

The Investigators propose to study the safety of autologous mesenchymal stromal cell transfer
using a biomatrix (the Gore Bio-A174; Fistula Plug) in a Phase I study using a single dose of
20 million cells. Fifteen adult patients with refractory, rectovaginal fistulizing Crohn's
disease will be enrolled. Participants will undergo standard adjuvant therapy including
drainage of infection and placement of a draining seton with continuation of pre-existing
anti-Crohn's therapy. If the participant is not currently diverted, then participants will
undergo a laparoscopic diversion with a loop ileostomy. Six weeks post placement of the
draining seton, the seton will be replaced with the MSC loaded Gore Bio-A fistula plug as per
current clinical practice. The participants 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.

Participants will be screened at outpatient clinic visits and interested qualified
participants will be offered participation in the trial and consented. At the first study
visit (Visit 1; Screening visit), the patient will be evaluated and assessed. Six weeks post
placement of the draining seton, the seton will be replaced with the MSC loaded Gore Bio-A
fistula plug. Participants will return on: Day 1, Week 2, Week 4, Week 8, Week 12, Week 24,
Week 52, and Week 104.

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