Allogenic stem cells for anal Crohn’s fistula: treating early improves the deep response rate

Abstract

Purpose: The aim of this study was to evaluate the real-life clinical and radiological efficacy of darvadstrocel injection into complex perianal fistulas in Crohn’s disease. Secondary endpoints were to assess symptomatic efficacy, outcomes and factors associated with complete combined clinical-radiological response (deep response). Methods: After marketing the product in France, all patients treated consecutively were included. A complete clinical response was defined by a complete closure of all external openings with no discharge on pressure. A partial response was defined by closure of ≥ 50% of external openings with no discharge on pressure. A complete radiological response (MRI), evaluated at least after six months of follow-up, was defined by a completely fibrotic sequela without abscess. Results: Forty-three patients were included (M/F: 22/21, median age 37 [26-45] years). The fistulas of all patients were already drained with seton(s) and were on biologic treatment. After a median follow-up of 383 [359-505] days, 28 (65%) patients showed a clinical response (22 complete and 6 partial). Only 16 (37%) achieved a deep response. The PDAI decreased significantly after treatment: 39 (91%) patients reported symptomatic improvement in terms of discharge, pain, and induration, and 28 (65%) no longer had any perineal symptoms. Only a short history of Crohn’s disease < 3 years was significantly associated with deep response (OD 4.5 [1.0-19.1], p = 0.04). Conclusion: Darvadstrocel injection resulted in a clinical response for two thirds of patients and deep response for one third. A shorter duration of Crohn’s disease was associated with deep response.

Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn’s Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn’s Fistula (the PRIME Study)

“…On the other hand, Dawoud et al 27 treated 14 patients in Austria and achieved a clinical remission of 57%, although again in a small number of patients. Fathallah et al 28 reported on a series of 43 patients treated with darvadstrocel in real-world practice, observing clinical remission in 37% of patients. Recently, they published their clinical and response rate in 27 consecutive patients after 12 months of follow-up.…”