Darvadstrocel in Complex Perianal Crohn’s Disease: Gastroenterology | June 2026
Clinical knowledge base written and curated by GastroAGI Team from primary medical literatureLast updated June 1, 2026
- Darvadstrocel is an allogeneic adipose-derived mesenchymal stem cell therapy designed to promote fistula healing through anti-inflammatory and immunomodulatory mechanisms. It is administered locally into conditioned fistula tracts after curettage and closure of the internal opening.
- Darvadstrocel previously generated considerable enthusiasm after the original ADMIRE-CD trial demonstrated significantly higher remission rates compared with placebo, leading to regulatory approval in Europe and Japan.
- The phase 3 ADMIRE CD II trial was designed as a larger confirmatory study involving patients from Europe, Israel, and North America with treatment-refractory complex perianal Crohn’s fistulas.
- A total of 568 patients were randomized to receive darvadstrocel or placebo following standard surgical conditioning of the fistula.
- The primary endpoint was combined remission at week 24, defined as closure of all treated external openings together with absence of significant collections on MRI.
- The study failed to meet its primary endpoint. Combined remission occurred in 48.8% of darvadstrocel-treated patients compared with 46.3% of placebo-treated patients, showing no statistically significant difference.
- Clinical remission, time to remission, and other secondary efficacy outcomes were also similar between treatment groups.
- Safety findings were reassuring, with no new safety concerns identified and adverse event rates similar between darvadstrocel and placebo.
- The negative result contrasts with the earlier ADMIRE-CD trial and raises important questions regarding the reproducibility of stem-cell–based therapies for fistulizing Crohn’s disease.
- These findings challenge the current role of darvadstrocel and suggest that future research may need to focus on alternative cell-based therapies, extracellular vesicles, or more targeted immunoregulatory approaches.
Bottom line: Despite promising results from the original ADMIRE-CD trial, the larger phase 3 ADMIRE CD II study failed to demonstrate superiority of darvadstrocel over placebo for complex perianal Crohn’s fistulas, casting doubt on the clinical benefit of stem-cell therapy in this setting.
