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Clinical data
Trade namesAlofisel
Other namesCX-601
License data
Routes of
ATC code
Legal status
Legal status
  • UK: POM (Prescription only) [1]
  • EU: Rx-only [2]

Darvadstrocel, sold under the brand name Alofisel, is a medication to treat complex perianal fistulas in adults with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.[1] It contains mesenchymal stem cells from fat tissue of adult donors.[2]

It was approved for use in the European Union in March 2018.[2] The approval was spearheaded by data published in the ADMIRE-CD trial.[2][3]

It was approved for use in Japan by Japan's Ministry of Health, Labour and Welfare (MHLW) in September 2021.[4]

Medical use[edit]

Darvadstrocel has been approved by the European Union for the treatment of adults with complex Crohn's perianal fistulas after conventional or biological medications have not worked.[2]

Mechanism of action[edit]

Darvadstrocel works by reducing inflammation and facilitating the growth of tissue in the fistula tract.[2][3]



The ADMIRE-CD trial was a phase III trial that assessed the safety and efficacy of darvadstrocel vs. placebo in adults with Crohn's perianal fistulas.[3][5] The study randomized a total of 212 patients.[3] 107 patients were given darvadstrocel and 105 patients were given placebo.[3]

After one year, the study found darvadstrocel to be effective in closing external fistula openings, compared to placebo.[3] Patients taking darvadstrocel had a combined remission of 56.3% and clinical remission of 59.2%.[3] The placebo controls had a combined remission of 38.6% and clinical remission of 41.6%.[3]


Published in 2022, the INSPECT study is a retrospective study that evaluated the long-term effectiveness and safety of darvadstrocel in patients with perianal fistulas in Crohn's disease that were treated in the ADMIRE-CD trial.[6] The study data showed that darvadstrocel or the maintenance treatment used can have long term clinical remission in patients.[6]


  1. ^ a b "Alofisel 5 million cells/mL suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 12 February 2020. Retrieved 27 February 2020.
  2. ^ a b c d e f "Alofisel EPAR". European Medicines Agency (EMA). Retrieved 27 February 2020.
  3. ^ a b c d e f g h Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, et al. (April 2018). "Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease". Gastroenterology. 154 (5): 1334–1342.e4. doi:10.1053/j.gastro.2017.12.020. PMID 29277560.
  4. ^ NS Healthcare Staff Writer (28 September 2021). "Takeda's Alofisel approved in Japan to treat fistulas in patients with Crohn's disease". NS Healthcare.
  5. ^ "Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD)". Clinicaltrials.gov. Archived from the original on 15 June 2012.
  6. ^ a b Panés, Julian; Bouma, Gerd; Ferrante, Marc; Kucharzik, Torsten; Nachury, Maria; de la Portilla de Juan, Fernando; Reinisch, Walter; Selvaggi, Francesco; Tschmelitsch, Jörg; Brett, Neil R.; Ladouceur, Martin (31 January 2022). "INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial". Inflammatory Bowel Diseases. 28 (11): 1737–1745. doi:10.1093/ibd/izab361. ISSN 1536-4844. PMC 9629463. PMID 35099555.

Further reading[edit]

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