Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II) (NCT04847739)
🩺 Plain-English Summary (8th-Grade Level)
A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm). Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Phoenix, Arizona
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Mayo Clinic Arizona — Phoenix, Arizona
- Office of Phillip Fleshner, MD — Los Angeles, California
- Stanford University — Redwood City, California
- UC Davis — Sacramento, California
- University of Colorado School of Medicine — Aurora, Colorado
- Mayo Clinic Jacksonville — Jacksonville, Florida
- University of Miami — Miami, Florida
- UChicago Medicine and Biological Sciences — Chicago, Illinois
- Indiana University Health University Hospital — Indianapolis, Indiana
- Mass Gen Hospital — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- NYU Langone Health — New York, New York
- Weill Cornell Medical College - NY Presbyterian Hospital — New York, New York
- University of Cincinnati — Cincinnati, Ohio
- Vanderbilt University Medical Center — Nashville, Tennessee
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Perianal Fistula clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.