Leading European cell therapy company TiGenix NV has just announced the successful full enrollment of patients for a Phase III clinical trial of Cx601, the company's pipeline treatment for complex perianal fistulas in patients with Crohn's disease. Crohn's disease is a type of inflammatory bowel disease (IBD) that causes serious abdominal discomfort, alterations in bowel movement, malabsorption, and even bleeding. It affects approximately 3.2 people out of every 1,000 in Europe and North America, and still does not have a known cure.
TiGenix employed its expertise in developing breakthrough treatments using allogeneic expanded adipose-derived stem cells in inflammatory and autoimmune diseases in evaluating Cx601's safety and efficacy in over 278 patients, who received the experimental drug across 51 centers in Europe and Israel. The study's main goal is to achieve remission of fistulous disease in patients with Crohn's disease, which is complete healing of the perianal tracts. The first collection of treatment responses will be at 24 weeks, followed by a post-treatment evaluation at 52 weeks.
Assessments of healing will be done clinically, and confirmed