The purpose of this research study is to determine whether the investigational product, AVB-114, is safe and effective to treat perianal fistulas in people with Crohn’s disease.

AVB-114 consists of stem cells taken from patient’s fat tissue placed into a bioabsorbable plug. Before participants receive study treatment, a small piece of fat, about the size of an olive, will be removed from their abdomen or thigh. This type of procedure is similar to a biopsy. This fat will be sent to a lab where stem cells will be collected from it and placed within the bioabsorbable plug. Bioabsorbable means that the plug material is not permanent and will be absorbed by the body. AVB-114 will be inserted into the fistula by the study doctor. It is expected, but not proven, that AVB-114 may promote healing of the fistula.

AVB-114 is considered investigational which means is still being tested and has not yet been approved as safe and effective for the treatment of perianal fistulas by the U.S. Food and Drug Administration (FDA) but has been approved for use in this clinical trial.

The study has 2 parts.

• Part 1: All required study visits for participants who initially receive study treatment and those who receive standard-of-care therapy (control arm).
• Part 2: Participants who are enrolled in the control arm may receive treatment with AVB-114 following week 36. 

Participation in this research will last approximately 28 months.