What question did this study set out to answer?

The study aims to evaluate the effectiveness of AVB-114 for inducing remission in patients with persistent Crohn’s perianal fistulas compared to standard of care.

March 27, 2026

AVB-114 Demonstrates Clinical Benefit in Persistent Crohn’s Perianal Fistulas: Randomized Cohort Results from the Multicenter STOMP2 Trial

Key Points

The study aims to evaluate the effectiveness of AVB-114 for inducing remission in patients with persistent Crohn’s perianal fistulas compared to standard of care.
Patients with a single perianal fistula who had failed previous treatments were selected.
Participants underwent surgical fistula optimization and adipose tissue biopsy for AVB-114 manufacturing.
Randomized 1:1 to receive either standard of care or AVB-114 implantation.
The primary endpoint was combined fistula remission at 36 weeks assessed through MRI.
At 36 weeks, combined remission rates were 8.3% for SoC vs. 45.8% for AVB-114, showing a significant difference (p=0.0078).
No subjects in the AVB-114 group had fluid collections >2cm at week 36.
MRI showed radiological healing in 5 AVB-114 subjects compared to 2 in SoC.
Both groups experienced treatment emergent adverse events, with AVB-114 showing no serious adverse effects.

Abstract

Objectives: Advanced therapies infrequently achieve complete fistula closure in patients with Crohn’s disease (CD). The primary objective of the STOMP2 clinical trial was to determine whether the implantable autologous cell therapy AVB-114 is effective in inducing remission of persistent Crohn’s perianal fistulas versus standard of care. Methods: Eligible patients had a single perianal fistula tract and had failed prior treatment or had documented medication intolerance to biologic or conventional CD therapy. All enrolled subjects underwent surgical fistula optimization and adipose tissue biopsy collection (in order to manufacture AVB-114) followed by 1:1 randomization to either standard of care (repeat fistula optimization including seton replacement) or AVB-114 implantation. The primary endpoint was combined fistula remission at 36 weeks, defined as closure of the external opening, no drainage of fluid despite gentle finger compression, and no collections >2cm in at least two of the three dimensions on MRI. Results: Subjects at 14 U.S. sites were equally randomized to SoC (N=24) or AVB-114 (N=24). Week 36 combined remission was 8.3% and 45.8% for subjects randomized to SoC and AVB-114, respectively (38% difference, 95% CI 11-60%; p=0.0078). At Week 36, MRI revealed no subjects with collections >2cm, radiological improvement (≥50% decrease in the MAGNIFI-CD score from baseline) in 1 SoC subject and 3 AVB-114 subjects, and radiological healing (complete resolution of T2-weighted hyperintensity in fistula tract) in 2 SoC subjects and 5 AVB-114 subjects. Through Week 36, there were 40 and 56 treatment emergent adverse events (TEAE) for SoC and AVB-114, respectively. There were no serious TEAEs in the AVB-114 group through Week 36. Conclusions: A significantly higher proportion of patients treated with AVB-114 achieved combined remission versus SoC, and the treatment was well tolerated. These data support the safety and efficacy of AVB-114 in persistent Crohn’s perianal fistulas.

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