Perianal Fistulas in Crohn’s Patients Effectively Treated in Long Term with Cx601, Study Finds

Perianal Fistulas in Crohn’s Patients Effectively Treated in Long Term with Cx601, Study Finds
TiGenix’s lead compound Cx601 is a safe and effective long-term treatment of complex perianal fistulas in Crohn’s disease patients, a clinical trial reports. The positive results come from the 104-week extension period of ADMIRE-CD, a randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT01541579) looking to confirm the safety and efficacy of a single administration of Cx601 in the treatment of complex perianal fistulas in Crohn's disease patients. Cx601 treatment consists of injecting previously allogeneic expanded adipose-derived stem cells, or eASC, (i.e., stem cells derived from adipose tissue of a donor, and not derived from patients themselves) directly into the lesions. The study’s primary endpoint was closure of all treated external openings draining at baseline within 24 weeks of treatment with lack of collections over 2 cm (confirmed by magnetic resonance imaging). In total, 212 patients were randomized to receive Cx601 or a placebo. TIGenix reported that Cx601 achieved statistical superiority on the primary endpoint, with 49.5 percent of patients exhibiting combined remission, compared to 34.3 percent in the placebo group, in August 2015. In terms of safety, adverse effects were comparable between Cx601 and placebo arms. A follow-up analysis of ADMIRE-CD, conducted at 52 weeks after treatment in
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