Stem Cell

Stem Cell Therapy for Perianal Fistulas in Crohn’s Patients Shows Benefits in Phase 3 Trial

Stem Cell Therapy for Perianal Fistulas in Crohn’s Patients Shows Benefits in Phase 3 Trial

The 24-week results of a Phase 3 trial showing the effectiveness of the investigational therapy Cx601 in the treatment of complex perianal fistulas in patients with Crohn’s disease were recently published in The Lancet, according to Takeda Pharmaceutical and TiGenix.

The study is titled “Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomised, double-blind controlled trial.”

Patients with Crohn’s disease often exhibit complex perianal fistulas for which there are limited treatment options. The investigational agent Cx601 is a suspension of allogenic adipose-derived stem cells (eASC) that are being developed to treat these fistulas in patients who failed conventional therapies, including immunosuppressants or anti-TNF agents.

Following positive Phase 2 results, TiGenix initiated a randomized, double-blind, placebo-controlled Phase 3 trial in Europe and Israel, called ADMIRE-CD (NCT01541579), which showed that a single injection of Cx601 significantly increased the combined remission of the complex perianal fistulas, as assessed by the closure of all treated external openings that were draining at baseline, despite gentle finger compression. MRI…