{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T21:42:00Z","timestamp":1791236520700,"version":"4.1.0"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2022,1,31]],"date-time":"2022-01-31T00:00:00Z","timestamp":1643587200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Takeda Pharmaceuticals International Co"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,11,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The efficacy of a single administration of darvadstrocel (expanded allogeneic adipose-derived mesenchymal stem cells) for treating complex perianal fistulas in patients with Crohn\u2019s disease was demonstrated in a randomized, double-blind trial (ADMIRE-CD [Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn\\'s Disease] trial). The current chart review study (INSPECT [A retrospectIve chart review study evaluatINg the longer-term effectiveneSs of darvadstrocel in PatiEnts who CompleTed ADMIRE-CD]) evaluated the longer-term effectiveness and safety of darvadstrocel.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Eligible patients had completed at least 52 weeks in the ADMIRE-CD trial. Data on clinical remission and fistula relapse outcomes were collected retrospectively at 104 and 156 weeks after treatment. Adverse events of special interest (tumorigenicity and ectopic tissue formation) were collected up to 208 weeks after treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Eighty-nine patients were included (43 darvadstrocel patients, 46 control subjects). At 52, 104, and 156 weeks posttreatment, clinical remission was observed in 29 (67.4%) of 43, 23 (53.5%) of 43, and 23 (53.5%) of 43 darvadstrocel-treated patients, compared with 24 (52.2%) of 46, 20 (43.5%) of 46, and 21 (45.7%) of 46 control subjects, respectively. In patients with clinical remission at week 52, this remission was sustained at 104 and 156 weeks after treatment in 19 (65.5%) of 29 and 16 (55.2%) of 29 darvadstrocel-treated patients and in 17 (70.8%) of 24 and 13 (54.2%) of 24 control subjects, respectively. Time to fistula relapse and incidence of fistula relapse or new fistula occurrence were not significantly different between groups. Tumorigenicity was reported for 1 (2.2%) patient in the control group (malignant epidermoid carcinoma). No ectopic tissue formation was reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Real-world follow-up of patients from the ADMIRE-CD trial indicates that clinical remission of complex perianal fistulas can be sustained in the long term irrespective of whether it is achieved through darvadstrocel administration or maintenance treatment regimens and confirms a favorable long-term safety profile of darvadstrocel.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izab361","type":"journal-article","created":{"date-parts":[[2022,1,31]],"date-time":"2022-01-31T15:42:50Z","timestamp":1643643770000},"page":"1737-1745","source":"Crossref","is-referenced-by-count":51,"title":["INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn\u2019s Disease Treated in the ADMIRE-CD Trial"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4971-6902","authenticated-orcid":false,"given":"Julian","family":"Pan\u00e9s","sequence":"first","affiliation":[{"name":"Inflammatory Bowel Disease Unit, Hospital Cl\u00ednic de Barcelona, IDIBAPS, CIBERehd , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerd","family":"Bouma","sequence":"additional","affiliation":[{"name":"Amsterdam Gastroenterology Endocrinology and Metabolism, Department of Gastroenterology and Hepatology, Amsterdam UMC , Amsterdam , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1492-0716","authenticated-orcid":false,"given":"Marc","family":"Ferrante","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals Leuven , KU Leuven, Leuven , 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Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Department for Gastroenterology and Hepatology, Medical University of Vienna , Vienna , Austria"},{"name":"Division of Gastroenterology, McMaster University , Hamilton, ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Selvaggi","sequence":"additional","affiliation":[{"name":"Unit of Colorectal Surgery, Department of Medical, Surgical, Neurological, Metabolic and Ageing Sciences, University of Campania Luigi Vanvitelli , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Tschmelitsch","sequence":"additional","affiliation":[{"name":"Department of Surgery, Hospital Barmherzige Br\u00fcder , Sankt Veit an der Glan , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil 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