Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
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.