AVB-114 Demonstrates Clinical Benefit in Persistent Crohn's Perianal Fistulas: Randomized Cohort Results From the Multicenter STOMP2 Trial.
David A Schwartz, Eric Dozois, Eric Ehman et al.
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In 30 seconds
The multicenter, randomized STOMP2 trial compared implantable autologous cell therapy AVB-114 with standard care in patients with Crohn’s disease and a persistent single perianal fistula after prior treatment failure or intolerance. After surgical fistula optimization, 48 participants were randomized equally between groups. At week 36, combined fistula remission—based on external closure, absence of drainage, and MRI findings—occurred in 45.8% with AVB-114 and 8.3% with standard care (38% difference, 95% CI 11%-60%; P = 0.0078). No serious treatment-emergent adverse events were reported in the AVB-114 group through week 36.
Key findings
- At week 36, combined remission was 45.8% with AVB-114 versus 8.3% with standard care (38% difference, 95% CI 11%-60%; P = 0.0078).
- MRI showed radiological improvement in 3 AVB-114 subjects and 1 standard-care subject; radiological healing occurred in 5 and 2 subjects, respectively.
- Through week 36, there were 56 treatment-emergent adverse events with AVB-114 and 40 with standard care; no serious events occurred in the AVB-114 group.
Why it matters
Persistent perianal fistulas in Crohn’s disease can remain difficult to close with existing therapies. In this randomized comparison, AVB-114 was associated with a substantially higher rate of combined clinical and MRI-defined remission at 36 weeks than standard care. The findings add controlled evidence for an autologous cell-based approach, while the follow-up and population studied define the scope of the result.
What to keep in mind
The trial included 48 participants with a single fistula tract and reports outcomes through week 36; applicability to other fistula patterns or longer-term outcomes is uncertain.