Avobis Bio, LLC

The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured.

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.