| Página principal > Artículos > Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: A randomized clinical trial with long-term follow-up > MARC |
000131392 001__ 131392 000131392 005__ 20240208155436.0 000131392 0247_ $$2doi$$a10.1002/sctm.19-0271 000131392 0248_ $$2sideral$$a117284 000131392 037__ $$aART-2020-117284 000131392 041__ $$aeng 000131392 100__ $$aGarcia-Arranz, M. 000131392 245__ $$aAutologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: A randomized clinical trial with long-term follow-up 000131392 260__ $$c2020 000131392 5060_ $$aAccess copy available to the general public$$fUnrestricted 000131392 5203_ $$aThe aim of this clinical trial (ID Number NCT01803347) was to determine the safety and efficacy of autologous adipose-derived stem cells (ASCs) for treatment of cryptoglandular fistula. This research was conducted following an analysis of the mistakes of a same previous phase III clinical trial. We designed a multicenter, randomized, single-blind clinical trial, recruiting 57 patients. Forty-four patients were categorized as belonging to the intent-to-treat group. Of these, 23 patients received 100 million ASCs plus intralesional fibrin glue (group A) and 21 received intralesional fibrin glue (group B), both after a deeper curettage of tracks and closure of internal openings. Fistula healing was defined as complete re-epithelialization of external openings. Those patients in whom the fistula had not healed after 16 weeks were eligible for retreatment. Patients were evaluated at 1, 4, 16, 36, and 52 weeks and 2 years after treatment. Results were assessed by an evaluator blinded to the type of treatment. After 16 weeks, the healing rate was 30.4% in group A and 42.8% in group B, rising to 55.0% and 63.1%, respectively, at 52 weeks. At the end of the study (2 years after treatment), the healing rate remained at 50.0% in group A and had reduced to 26.3% in group B. The safety of the cellular treatment was confirmed and no impact on fecal continence was detected. The main conclusion was that autologous ASCs for the treatment of cryptoglandular perianal fistula is safe and can favor long-term and sustained fistula healing. 000131392 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII/FEDER/RD16-0011-0005$$9info:eu-repo/grantAgreement/ES/ISCIII/FEDER/RD16-0011-0013$$9info:eu-repo/grantAgreement/ES/ISCIII/FEDER/RD16-0011-0015 000131392 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000131392 590__ $$a6.94$$b2020 000131392 591__ $$aCELL & TISSUE ENGINEERING$$b6 / 29 = 0.207$$c2020$$dQ1$$eT1 000131392 592__ $$a1.78$$b2020 000131392 593__ $$aCell Biology$$c2020$$dQ1 000131392 593__ $$aMedicine (miscellaneous)$$c2020$$dQ1 000131392 593__ $$aDevelopmental Biology$$c2020$$dQ1 000131392 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000131392 700__ $$aGarcia-Olmo, D. 000131392 700__ $$aHerreros, M.D. 000131392 700__ $$0(orcid)0000-0003-4173-7212$$aGracia-Solana, J.$$uUniversidad de Zaragoza 000131392 700__ $$aGuadalajara, H. 000131392 700__ $$ade la Portilla, F. 000131392 700__ $$aBaixauli, J. 000131392 700__ $$aGarcia-Garcia, J. 000131392 700__ $$0(orcid)0000-0001-7964-1166$$aRamirez, J.M.$$uUniversidad de Zaragoza 000131392 700__ $$aSanchez-Guijo, F. 000131392 700__ $$aProsper, F. 000131392 700__ $$athe, FISPAC, Collaborative, Group 000131392 7102_ $$11013$$2090$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Cirugía 000131392 773__ $$g9, 3 (2020), 295-301$$pStem cells translational medicine$$tStem Cells Translational Medicine$$x2157-6564 000131392 8564_ $$s841877$$uhttps://zaguan.unizar.es/record/131392/files/texto_completo.pdf$$yVersión publicada 000131392 8564_ $$s2298580$$uhttps://zaguan.unizar.es/record/131392/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000131392 909CO $$ooai:zaguan.unizar.es:131392$$particulos$$pdriver 000131392 951__ $$a2024-02-08-14:38:14 000131392 980__ $$aARTICLE
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