Darvadstrocel

Darvadstrocel is a suspension of expanded human allogeneic adipose-derived mesenchymal stem cells extracted from the subdermal adipose tissue of healthy donors via liposuction. Darvadstrocel was first approved by the European Commission on March 23, 2018, under the brand name Alofisel. It is indicated for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn’s disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy. It is the first mesenchymal stem cell therapy approved in Europe for this therapeutic indication. Perianal fistula is a common manifestation of Crohn’s disease and is often difficult to manage, as it may be associated with complex presentations and symptoms. Darvadstrocel exhibits immunomodulatory and anti-inflammatory effects: it aims to reduce local inflammation and enhance tissue repair in perianal fistulas.

Darvadstrocel is indicated for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Darvadstrocel should be used only after conditioning of the fistulas.