Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
Public ClinicalTrials.gov record NCT04847739. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04847739
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2021
- Primary completion
- Apr 30, 2025
- Completion
- Jul 31, 2026
- Last update posted
- Jul 31, 2024
2021 – 2026
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Office of Phillip Fleshner, MD | Los Angeles | California | 90048 | — |
| Stanford University | Redwood City | California | 94063 | — |
| UC Davis | Sacramento | California | 95817 | — |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| University of Miami | Miami | Florida | 33136 | — |
| UChicago Medicine and Biological Sciences | Chicago | Illinois | 60637 | — |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | — |
| Mass Gen Hospital | Boston | Massachusetts | 02114 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Weill Cornell Medical College - NY Presbyterian Hospital | New York | New York | 10021 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04847739, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2024 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04847739 live on ClinicalTrials.gov.