{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T14:45:21Z","timestamp":1767797121268,"version":"3.49.0"},"reference-count":10,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T00:00:00Z","timestamp":1766966400000},"content-version":"unspecified","delay-in-days":28,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"This project is funded by DGOS through the grant PHRCi","award":["PHRCi 2013 #13-075"],"award-info":[{"award-number":["PHRCi 2013 #13-075"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,12,13]]},"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Crohn\u2019s disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract distinguished by progressive bowel damage with a risk of structuring and penetrating complications. It is characterised by focal or segmental transmural inflammation that disrupts intestinal mucosal integrity and favours the development of abscesses and fistulas. Perianal fistula develops in 13%\u201339% of patients with CD. Their care is difficult but improves with medical and surgical treatment to preserve anal continence and avoid a maximum proctectomy. Combined treatment with seton placement and concomitant anti-TNF (infliximab, adalimumab) allows wound healing in 40%\u201370% of cases. The currently available treatments are not curative and fail to provide a long-term resolution. The injection of adipose stromal cells is currently being evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischaemia, osteoarthritis, systemic sclerosis, etc). Immunoregulatory and anti-inflammatory properties of AdMSC (adipose-derived stroma\/stem cells) are responsible for accelerating healing and represent an innovative approach for treating perianal fistulas associated with CD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This phase I\/IIa study is designed to assess the treatment of complex perianal fistulas linked with CD after failure of conventional treatment by injection of AdMSC (CellReady) into the fistula. Two doses of associated AdMSC will be tested for a dose escalation (5\u00d710\n                      <jats:sup>7<\/jats:sup>\n                      \u2009and 10\u00d710\n                      <jats:sup>7<\/jats:sup>\n                      cells) and injected into the wall of the fistula. Those eligible for inclusion include patients with controlled luminal CD characterised by a Harvey-Bradshaw score below or equal to eight and diagnosed on clinical, endoscopic, histological and\/or radiological criteria, a colonoscopy dating back less than 1 year without ulcer in the rectum and presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports. All patients must have social security insurance or equivalent social protection. The aim of this study is to determine the optimal dose corresponding to maximum efficacy 6 months after injection of cells with a treatment-related adverse event rate of 20%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The EU CT number 2024-511821-75-00 was approved by the following Ethics Committee: CPP (committee for the protection of persons in French: comit\u00e9 de protection des personnes) Ouest 1 \u2013 Tours #2024UEMED-18 and ANSM (French Agency for the Safety of Health and Medicinal Products in French : Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9) #2024-511821-75-00 (Sponsor number RC31\/13\/7030, protocol V2.1). The results will be disseminated through conventional scientific channels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06636032\">NCT06636032<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                    <jats:p>The results will be disseminated through conventional scientific channels.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-104517","type":"journal-article","created":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T06:30:18Z","timestamp":1767076218000},"page":"e104517","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Rationale and design of the AlloFIST trial: a phase I\/IIa study to evaluate dose escalation of allogeneic adipose-derived stroma\/stem cells for the treatment of Crohn\u2019s fistula"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06636032","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06636032","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06636032","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2040-3045","authenticated-orcid":false,"given":"Etienne","family":"Buscail","sequence":"first","affiliation":[{"name":"Colorectal Surgery, University Hospital Centre Toulouse, Toulouse, France"},{"name":"Digestive Health Research Institute, Toulouse, Occitanie, France"},{"name":"Centre d\u2019investigation clinique de Toulouse, Toulouse, Occitanie, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cyrielle","family":"Gilletta de Saint Joseph","sequence":"additional","affiliation":[{"name":"Gastroenterology, University Hospital Centre Toulouse, Toulouse, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marine","family":"Lebrin","sequence":"additional","affiliation":[{"name":"Centre d\u2019investigation clinique de Toulouse, Toulouse, Occitanie, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ines","family":"Frument","sequence":"additional","affiliation":[{"name":"Centre d\u2019investigation clinique de Toulouse, Toulouse, Occitanie, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabian","family":"Gross","sequence":"additional","affiliation":[{"name":"Centre d\u2019investigation clinique de Toulouse, Toulouse, Occitanie, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Bournet","sequence":"additional","affiliation":[{"name":"Gastroenterology, University Hospital Centre Toulouse, Toulouse, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louis","family":"Buscail","sequence":"additional","affiliation":[{"name":"Gastroenterology, CHU Toulouse, Toulouse, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian","family":"Culetto","sequence":"additional","affiliation":[{"name":"Gastroenterology, University Hospital Centre Toulouse, Toulouse, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fatima","family":"Mokrane","sequence":"additional","affiliation":[{"name":"Radiology, University Hospital Centre Toulouse, Toulouse, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie Charlotte","family":"Delchier","sequence":"additional","affiliation":[{"name":"Radiology, University Hospital Centre Toulouse, Toulouse, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabelle","family":"Quelven","sequence":"additional","affiliation":[{"name":"Pharmacy, University Hospital 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