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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Sep 2025

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At a glance

  • Drugs AVB-114 (Primary)
  • Indications Rectal fistula
  • Focus Therapeutic Use
  • Acronyms STOMP-II
  • Sponsors Avobis Bio

Most Recent Events

  • 07 Aug 2025 According to Avobis Bio LLC media release, RMAT designation provides benefits including frequent FDA interactions and discussion of potential surrogate endpoints or accelerated approval.
  • 07 Aug 2025 According to Avobis Bio LLC media release, primary analysis results will be submitted as a late-breaking abstract to an upcoming preeminent gastroenterology conference.
  • 07 Aug 2025 According to Avobis Bio LLC media release, company announced that primary analysis of the STOMP-II clinical trial has been completed and led to a request to the U.S. Food and Drug Administration (FDA) for Regenerative Medicine Advanced Therapy (RMAT) designation for AVB-114 for Crohn's perianal fistulas. Based on results of primary analysis leads to FDA RMAT submission and late-breaking abstract for implantable cell therapy.

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