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

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

Brief description of study

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. Fistula remission in the investigational treatment group will be compared to a standard of care control arm. The design is prospective, multicenter, randomized, open-label with blinded outcome assessment, add-on therapy, parallel arm (active control and investigational treatment) study. The study has two parts: Part 1: includes screening, enrollment, randomization, all study follow-up visits for treatment arm subjects, and primary follow-up visits for control arm subjects. Part 2: control arm subjects that receive AVB-114 treatment following the Week 36 study visit (primary endpoint) and are then followed for an additional 52 weeks.

Clinical Study Identifier: s22-01355

ClinicalTrials.gov Identifier: NCT04847739

Principal Investigator: David P Hudesman.

Other Investigators: Shannon Chang, Adam Faye, Simon J Hong, Andre Da Luz Moreira, Ariela Holmer, Jordan E Axelrad, Jessica N. Simon.

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