Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)

Summary

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.

Timeline

Start

2021-09-13

Primary completion

2025-05

Completion

2026-08

Outcome

Met primary endpoint

paper 38% difference, 95% CI 11%-60%; P = 0.0078 PMID 41879234 ↗

Publications

• Schwartz DA, Dozois E, Ehman E, Faubion W Jr, Hudesman D, Johnson T, Pabla B, Papadakis K, Fleshner P. AVB-114 Demonstrates Clinical Benefit in Persistent Crohn's Perianal Fistulas: Randomized Cohort Results From the Multicenter STOMP2 Trial. Am J Gastroenterol. 2026 Mar 25. doi: 10.14309/ajg.0000000000004005. Online ahead of print.

Drugs

Indications