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Implantable Stem Cell Therapy Fast Tracked for Crohn Disease Perianal Fistulas
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.
What To Know
FDA Fast Track was granted to AVB-114, an investigational implantable therapy that uses a patient’s own fat-derived stem cells seeded into a bioabsorbable plug and inserted into perianal fistulas.
The designation was supported by safety and feasibility data from a single-arm phase 1 trial (STOMP-I) reporting clinical healing and MRI responses; a randomized phase 2 trial (STOMP-II; NCT04847739) is underway with results expected mid-2025.
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.
