NEW YORK (Reuters Health) – Local administration of allogeneic expanded adipose-derived stem cells (Cx601) improves resolution of complex perianal fistulas in patients with Crohn’s disease, according to results from the ADMIRE CD trial.
“The therapy may be particularly beneficial for patients with active perianal fistulas and absent or mild luminal disease activity in whom avoidance of systemic immunosuppression is preferred,” Dr. Julian Panes from Hospital U. Fundacion Jimenez Diaz, Madrid, Spain, told Reuters Health by email. “The treatment has a localized effect and has proven very safe.”
As many as 50% of patients with Crohn’s disease have perianal fistulas, and closure rates are as low as 23% even in patients who otherwise respond to anti-TNF treatment. Moreover, 70% of patients relapse when such treatment is discontinued.
Dr. Panes and colleagues from 49 hospitals in Europe and Israel earlier found Cx601 to be safe and effective for treating complex perianal fistulas in Crohn’s disease patients who did not respond to conventional and/or biological treatments, with results as late as 24 weeks after treatment administration.
In the current study, they evaluated whether the initial responses observed with Cx601 were maintained up to 52 weeks after treatment administration. The study included 212 patients: 107 patients randomized to Cx601 and 105 to placebo.
Overall, 171 patients (80.7%) completed the 24-week follow-up and 131 (61.8%) completed the 52-week follow-up, according to the December 22 Gastroenterology online report.
In a modified intention-to-treat analysis, 56.3% of Cx601 recipients and 38.6% of controls (P=0.01) had achieved complete remission by 52 weeks, with a similar pattern at week 24 (51.5% vs. 35.6%, respectively).
Among patients who had achieved complete remission by week 24, more Cx601 recipients than controls (75.0% vs. 55.9%) had not relapsed by week 52, although this difference fell short of statistical significance.
The percentage of patients who experienced treatment-related, treatment-emergent adverse events through week 52 was nonsignificantly lower in the Cx601 group (20.4%) than in the control group (26.5%), and the 52-week rate of serious events of this type was similar in the two groups (roughly 7% in both).
“The therapy should be applied by surgeons with adequate training in perianal disease and educated on the technique of local stem cell injection,” Dr. Panes said.
TiGenix S.A.U. funded the study, employed four of the authors, and had various relationships with several others.
SOURCE: http://bit.ly/2En1nl7
Gastroenterology 2017.
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