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Medically reviewed by Dr. Shani S. Saks, D.O. on August 2, 2023

Darvadstrocel was found to be safe and effective for Crohn’s disease patients suffering from treatment-refractory complex perianal fistulas.

Darvadstrocel is a suspension of allogeneic adipose-derived mesenchymal stem cells (eASCs). Darvadstrocel is safe and effective in Crohn’s disease (CD) patients suffering from treatment-refractory complex perianal fistulas, based on previous European study findings. 

The current study aimed to investigate the safety and efficacy of darvadstrocel in Japanese luminal CD patients with active complex perianal fistulas. The findings, published in the Journal of Crohn’s and Colitis, showed that the tolerability and efficacy of darvadstrocel in the study population were comparable to those reported in the preceding European studies.

Study Characteristics

A total of 22 patients were enrolled and completed the follow-up period of 52 weeks. The per-protocol set (PPS) comprised 19 patients. In the intention-to-treat (ITT) group, the mean age of the CD patients was 36.4 ± 10.4 years, and the mean duration of disease was 11.3 ± 6.6 years.

Positive Disease Remission and Improvement in Patients at Week 52

Combined disease remission in patients in the ITT group was achieved in 59.1% of the patients at week 24, of whom, 11 were still in remission at week 52, with newly observed combined remission in four patients. At week 52, 68.2% had achieved combined remission.

At week 52, 90.9% of the patients had shown a response, and 72.7% of the patients had achieved clinical remission. The mean changes in the total Perianal Disease Activity Index (PDAI) score at week 24 and week 52 were -2.4 ± 2.2 and -2.8 ± 2.6, respectively, indicative of improvement.

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High Remission and Response Rates at Week 52

The clinical remission and response rates at week 52 were 72.7% and 86.4%, respectively. The mean changes in the Van Assche and Crohn’s Disease Activity Index scores at week 52 were -2.2 ± 4.9 and -20.9 ± 51.3, respectively. The magnetic resonance imaging (MRI) assessment indicated a reduction of infected granulation tissue and suppression of inflammation, which may lead to scarring and closure of the fistula tract.

Safety of Darvadstrocel in Crohn’s Disease Patients

Treatment-emergent adverse events (TEAEs) were experienced by 90.9% of the patients during the study period, with the most common being proctalgia, nasopharyngitis, nausea, anal fistula, CD, and acrochordon. A moderate increase in blood bilirubin was seen in one patient after 47 weeks. Only two patients experienced severe TEAEs, which were unrelated to darvadstrocel treatment. The serious TEAEs not associated with the treatment comprised tubulointerstitial nephritis, intestinal obstruction, urinary calculus, and an intestinal anastomosis complication.


Furukawa, S., Mizushima, T., Nakaya, R., Shibata, M., Yamaguchi, T., Watanabe, K., & Futami, K. (2022). Darvadstrocel for Complex Perianal Fistulas in Japanese Adults with Crohn’s Disease: A Phase 3 Study. Journal of Crohn’s and Colitis, 17(3), 369–378. https://doi.org/10.1093/ecco-jcc/jjac144