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

The purpose of this research study is to determine whether an investigational drug called 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 own fat (adipose) tissue, and placed into a bioabsorbable fistula plug. “Under investigation” means that the study product AVB-114, is still being tested and has not yet been approved as safe and effective for the treatment of perianal fistulas by the US Food and Drug Administration (FDA), but has been approved for use in this clinical trial.

Clinical Study Identifier: s22-01355

ClinicalTrials.gov Identifier: NCTTX1857

Principal Investigator: David P Hudesman.

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

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