A clinical trial has demonstrated the efficacy of adipose-derived mesenchymal cells in inducing and maintaining remission of complex perianal fistulas in patients with Crohn’s disease.
In a recent Phase III clinical trial, a suspension of allogeneic adipose-derived mesenchymal stem cells was demonstrated to induce and maintain remission of treatment refractory complex perianal fistulas in patients with Crohn’s disease.
Funder TiGenix NV (Leuven, Belgium) and investigator Takeda Pharmaceutical Company Ltd (Osaka, Japan) made the announcement at the 12th Congress of the European Crohn’s and Colitis Organisation (Barcelona, Spain).
“Perianal fistulizing Crohn’s disease is difficult to treat with currently available therapies and often leads to pain, swelling, infection and incontinence,” commented Asit Parikh, Head of Takeda’s Gastroenterology Therapeutic Area Unit. “Existing therapies are limited and associated with complications and a high failure rate. [This therapy] may offer patients an alternative treatment option.”
The randomized, double-blind, controlled study aimed to investigate the safety and efficacy of the investigational suspension compound, termed, Cx601 for the treatment of complex perianal fistulas in this patient population. Significantly, the results indicated that 17.7% more patients in the treated group achieved clinical and radiological combined remission at 52 weeks when compared with the control group (56.3% and 38.6%, respectively).
The rate of occurrence and type of treatment related adverse events (non-serious and serious) and discontinuations due to adverse events were similar in both groups.
“These data highlight that the efficacy and safety of a single administration of this treatment were maintained during 1 year of follow up,” said Marie Paule Richard, Chief Medical Officer at TiGenix. “It is important to also note that the definition of combined remission used in this study, which includes both clinical and radiological assessment by MRI, is more stringent than the criteria commonly used in previous large scale, randomized clinical trials evaluating perianal fistulas in Crohn’s disease, based only on clinical assessment.”
A global pivotal Phase III trial for US registration of Cx601 for the treatment of complex perianal fistulas is expected to begin in 2017.