{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:15:43Z","timestamp":1790741743990,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,10,3]],"date-time":"2024-10-03T00:00:00Z","timestamp":1727913600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["UEG Journal"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Local injection of darvadstrocel, a suspension of expanded adipose\u2010derived allogenic mesenchymal stem cells, has been used for treatment\u2010refractory perianal fistulas in Crohn's disease (CD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>This study aimed to investigate efficacy and safety of darvadstrocel for complex perianal fistulas in CD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A systematic search was conducted through April 2024 in relevant databases for observational studies evaluating darvadstrocel. A random\u2010effects meta\u2010analysis model was used to calculate the pooled effect sizes (proportions or incidence rates [IRs]) with 95% confidence intervals (CIs) of effectiveness and safety outcomes. The risk of bias was evaluated using the Joanna Briggs Institute Critical Appraisal Tool. The <jats:italic>I<\/jats:italic><jats:sup>2<\/jats:sup> value assessed heterogeneity. Sensitivity and subgroup analyses were also conducted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twelve studies were included with 595 patients. The pooled rate of patients achieving clinical remission, defined as fistula healing, was 68.1% at month 6 (95% CI 63.4\u201372.7) and 77.2% (95% CI 70.1\u201383.8) at month 12. Combined remission, defined as clinical remission and absence of collections &gt;2\u00a0cm confirmed by magnetic resonance imaging, was reported in 60.6% and in 69.7% of patients at months 6 and 12, respectively. The rate of patients with treatment failure, defined as no clinical remission at the last follow\u2010up (mean 18.7\u00a0months; SD 9.9), was 34.5%. Failure rate was independent of follow\u2010up time (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.85). For effectiveness outcomes, between\u2010study heterogeneity was negligible. Subgroup analysis indicated that none of the covariates modified the treatment effect. Pooled IRs per 100 patient\u2010years of adverse events (AE), serious AEs, perianal abscesses, and reoperations were 19.6, 3.2, 16.9 and 7.1, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Evidence from observational studies supports the efficacy and safety of darvadstrocel for complex perianal fistulas in CD. Studies have reported high fistula healing rates that can be sustained long\u2010term in most patients, with negligible between\u2010study heterogeneity, as well as a favorable safety profile.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ueg2.12673","type":"journal-article","created":{"date-parts":[[2024,10,3]],"date-time":"2024-10-03T11:39:37Z","timestamp":1727955577000},"page":"416-426","source":"Crossref","is-referenced-by-count":11,"title":["Darvadstrocel for complex perianal fistulas in Crohn's disease: A systematic review and meta\u2010analysis"],"prefix":"10.1002","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9166-7350","authenticated-orcid":false,"given":"Carlos","family":"Taxonera","sequence":"first","affiliation":[{"name":"Inflammatory Bowel Disease Unit Gastroenterology Department Hospital Cl\u00ednico San Carlos and Instituto de Investigaci\u00f3n del Hospital Cl\u00ednico San Carlos [IdISSC]  Madrid 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