An intralesional injection of mesenchymal stem cells can significantly increase remission rates in patients with complex perianal fistulas associated with Crohn’s disease, an experimental study shows.
According to the authors of the Phase 3 randomised double-blind placebo controlled trial of 212 adults across 49 hospitals and seven countries in Europe and Israel their findings suggest that local treatment with Cx601 added on to established treatments for Crohn’s disease might open new therapeutic options for refractory perianal disease.
Professor Rupert Leong, Head of the Inflammatory Bowel Disease Service at Concord Hospital, said fistulising Crohn’s disease remained a difficult-to-manage phenotype associated with significant morbidity.
“A local stem cell based therapy is very attractive if patients are refractory to standard antibiotics and/or anti-TNF agents.
The alternative option includes surgical flaps, fistula closure devices and even diversion of faecal content via a stoma,” he told the limbic.
The study published in The Lancet found 50% of patients treated with the allogeneic adipose derived stem cells (Cx601) achieved the primary endpoint of combined remission within 24 weeks compared to 34% of patients receiving a placebo (difference 15·2%, 97·5% CI 0·2–30·3; p=0·024).
All patients continued to receive their background treatment.
Professor Leong said the research provided good preliminary data on a novel therapy and minimally invasive alternative to closure.
“The dose and the best regimen for the stem cells remains to be determined and further efficacy using higher doses might be possible. Durability of improvement also needs testing,” he said.