Darvadstrocel for the treatment of patients with perianal fistulas in Crohn's disease

P G Kotze, Antonino Spinelli, J Warusavitarne, F Di Candido, K Sahnan, S O Adegbola, S Danese

Research output: Contribution to journalReview articlepeer-review


Despite significant advances in medical and surgical therapy for perianal fistulas in Crohn's disease (CD), treatment results are still modest, and a specific need for more effective therapies is a reality. Darvadstrocel is composed of expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue and constitutes the first stem cell therapy for perianal fistulizing CD to receive approval from the European Medicines Agency (EMA). This therapy is injected in both internal and external openings, as well as inside the fistula tracks, to induce fistula healing. In this monograph, the authors review the preclinical pharmacology of darvadstrocel, as well as pharmacokinetics and metabolism, and cover the main indications and detailed information on the efficacy and safety profile of the agent. Possible interactions with other agents used to treat CD are also explored. Darvadstrocel is a safe and effective therapy for perianal complex fistulas in CD, and represents the beginning of a new era of mesenchymal stem cell therapy in this difficult phenotype of the disease.

Original languageEnglish
Pages (from-to)95-105
Number of pages11
JournalDrugs of Today
Issue number2
Publication statusPublished - Feb 2019


  • Adipose Tissue/cytology
  • Adult
  • Crohn Disease/complications
  • Humans
  • Rectal Fistula/etiology
  • Stem Cell Transplantation
  • Treatment Outcome


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