Cure8 news brief
Perianal fistulas are a serious, hard-to-treat complication of Crohn disease. Fast Track status may speed development of a new implantable stem cell therapy that aims to close fistulas and promote local healing. Ongoing randomized trials will determine whether it is safe and effective compared with standard care.
People with Crohn disease and perianal fistulas, clinicians who treat fistulizing disease (gastroenterologists, colorectal surgeons), and researchers studying cell therapies or fistula treatments.
AVB-114 is an autologous (patient-derived) mesenchymal stem cell therapy delivered on a dissolvable plug placed into the fistula tract. Phase 1 STOMP-I focused on safety and feasibility in adults with complex single-tract Crohn’s perianal fistulas and reported no serious adverse events related to the device in the 12-month analysis.
The phase 2 STOMP-II trial is testing efficacy versus standard of care in patients whose fistulas did not respond to biologics or conventional therapy, with a combined clinical and radiological remission primary endpoint.
This news describes regulatory progress (Fast Track) that may speed development and discussions with the FDA but does not mean the treatment is approved or widely available yet.
Fast Track designation facilitates more frequent FDA interactions and a potentially faster review path but is not an approval. The supporting data come from a small, single-arm phase 1 study; larger randomized data from STOMP-II are pending. Readers should look for the full STOMP-II results and peer-reviewed publications for stronger evidence.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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