Stem Cell Coated Fistula Plug in Patients With Crohn's RVF
Condition: Fistula Vagina; Crohn Disease
MeSH terms: Crohn Disease; Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of using an autologous mesenchymal
      stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's
      disease. This is an autologous product derived from the patient and used only for the same
      patient. Participants will be in this study for two years. There is potential to continue to
      monitor participants' progress with regular visits as part of standard of care. All study
      visits take place at Mayo Clinic and Rochester, MN.

      The study visit schedule is as follows:

      Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility
      of fistula tract, take fat biopsy, if eligible, and fecal diversion.

      Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement
      Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8;
      Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12).
      Visit 10 (Week 104, Month 24)
    

Detailed description: 
      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.
    

Intervention name(s): MSC-AFP
Intervention type(s): Drug
Intervention description(s): Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cells.
Other intervention name(s): • mesenchymal stromal cell coated fistula plug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment