ALOFISEL, (darvadstrocel), stem cell therapy

High clinical benefit in the treatment of complex perianal fistulas in Crohn's disease in combination with a biologic therapy, when fistulas have shown an inadequate response to at least one biologic therapy, and minor clinical added value in the therapeutic strategy.

• ALOFISEL has a marketing authorisation for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

• Its administration requires general or regional anaesthesia and a surgical procedure, after conditioning of fistulas.

• Its therapeutic benefit has been established only in patients with  quiescent or non-active Crohn’s disease, with complex but not complicated perianal fistulas and following an inadequate response (nonclosure of fistula openings) to at least one biologic therapy in the previous 6 months. In this situation, its efficacy in terms of remission is moderate after 24 weeks compared to placebo.

• It has no role in the event of failure of conventional therapy alone or in patients with proctitis.