BACKGROUND: Perianal fistulas of Crohn's disease (CD) create a significant burden on patients' lives. However, the efficacy and safety of adipose-derived mesenchymal stem cell treatment are contradicting, and real-world evidence is lacking. AIMS: To examine the usability of darvadstrocel therapy in managing perianal CD. METHODS: We enrolled patients with CD and perianal fistulas in this retrospective multicenter study. The primary outcome was perianal clinical remission (defined as all treated fistulas closed) at weeks 26 and 52. Secondary outcomes were clinical response rates (≥ 1 fistulas closed), perianal activity (PDAI), patient satisfaction, and adverse events. Data were recorded at baseline and weeks 12, 26 and 52. Prediction of primary outcomes was performed by logistic regression. RESULTS: Overall, among 223 patients (male/female ratio: 0.48), perianal clinical remission was achieved in 78.2% and 62.3% until weeks 26 and 52. Baseline PDAI score (OR 0.75), number of fistulas (OR 0.28) and the number of weeks after preparation for surgery (OR 0.98) were associated with treatment failure. The clinical response rates were 84.8% and 79.8% at weeks 26 and 52. Improvement of subjective perianal symptoms was achieved in 77.8% and 78.4% of patients, respectively. Adverse events occurred in 13.5% of patients; perianal abscesses and proctalgia were the most frequently reported. CONCLUSION: Effectiveness data were higher than in clinical trials. The safety profile was reassuring, and patients' satisfaction was high. Appropriate patient selection, fistula preparation and expertise may help to achieve treatment success.

Colorectal Unit Surgical Division Tel Aviv Medical Center Affiliated to the Faculty of Medicine Tel Aviv University Tel Aviv Israel

Department of General Surgery Shaare Zedek Medical Center The Hebrew University School of Medicine Jerusalem Israel

Department of Medicine Albert Szent Györgyi Medical School University of Szeged Szeged Hungary

Department of Surgery Albert Szent Györgyi Medical School University of Szeged Szeged Hungary

Department of Surgery Transplantation and Gastroenterology Faculty of Medicine Semmelweis University Budapest Hungary

Digestive Diseases Institute IBD MOM Unit Shaare Zedek Medical Center Hebrew University Jerusalem Israel

Division of Gastroenterology 1st Department of Medicine Medical School University of Pécs Pécs Hungary

HCEMM USZ Translational Colorectal Research Group Szeged Hungary

IBD Unit Tel Aviv Medical Center Affiliated to the Faculty of Medicine Tel Aviv University Tel Aviv Israel

Surgical Department Clinical IBD Center ISCARE Prague Czech Republic

Surgical Department University Hospital Kralovske Vinohrady Prague Czech Republic

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