Stem Cell Coated Fistula Plug in Patients With Crohn's RVF
Status:
Completed
Trial end date:
2020-09-20
Target enrollment:
Participant gender:
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)