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Darvadstrocel for the treatment of perianal fistulas in Crohn's disease. INTRODUCTION: Perianal fistulizing Crohn's disease is associated with a poor quality of life and current medical and surgical treatment options are limited. Darvadstrocel, composed of mesenchymal stem (stromal) cells (MSC), has recently been approved by the European Medicines Agency (EMA) for the treatment for perianal disease. This drug profile educates the reader with this novel treatment approach. AREAS COVERED: A literature search was performed on PubMed with focus on perianal fistulizing Crohn's disease and mesenchymal stem (stromal) cells. This review summarizes evidence of the current standard of care and discusses the mechanism of action, manufacturing, and application and safety of darvadstrocel. EXPERT OPINION: Darvadstrocel is a safe and effective therapy for complex perianal fistulizing Crohn's disease.