Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up
The 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...
| Autores: | , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2020 |
| País: | España |
| Institución: | Universidad de Navarra |
| Repositorio: | Dadun. Depósito Académico Digital de la Universidad de Navarra |
| Idioma: | inglés |
| OAI Identifier: | oai:dadun.unav.edu:10171/65509 |
| Acceso en línea: | https://hdl.handle.net/10171/65509 |
| Access Level: | acceso abierto |
| Palabra clave: | Complex cryptoglandular fistula Mesenchymal stem cells Phase III |
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Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-upGarcía-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998Herreros, M.D. (María Dolores)|||/items/5f7ca674-900a-4834-a92e-ab5374f1e7d0Gracia-Solana, J. (José)|||/items/92105c65-715d-4b4e-abe9-95512c92cbcbGuadalajara, H. (Héctor)|||/items/cd73ff10-d4bb-426c-b7c9-0741bac4430cde-la-Portilla, F. (Fernando)|||/items/c5afd819-79e9-4562-858f-87f4c222dc5eBaixauli-Fons, J. (Jorge)|||/items/c863985d-f450-4807-a4fe-56d26f6e8dfaGarcia-Garcia, J. (Jacinto)|||/items/57fca8ad-e34d-4e81-a9d9-cb1ccd6ea8ccRamirez, J.M. (José Manuel)|||/items/e5ef340d-f995-4a9b-9168-c1f62eb2026dSanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1Complex cryptoglandular fistulaMesenchymal stem cellsPhase IIIThe 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.WileyDadun. Depósito Académico Digital Universidad de Navarra20232023-02-2020202020-01-0120202020-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/65509reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/655092026-06-21T12:47:57Z |
| dc.title.none.fl_str_mv |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up |
| title |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up |
| spellingShingle |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up García-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5 Complex cryptoglandular fistula Mesenchymal stem cells Phase III |
| title_short |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up |
| title_full |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up |
| title_fullStr |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up |
| title_full_unstemmed |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up |
| title_sort |
Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up |
| dc.creator.none.fl_str_mv |
García-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5 Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998 Herreros, M.D. (María Dolores)|||/items/5f7ca674-900a-4834-a92e-ab5374f1e7d0 Gracia-Solana, J. (José)|||/items/92105c65-715d-4b4e-abe9-95512c92cbcb Guadalajara, H. (Héctor)|||/items/cd73ff10-d4bb-426c-b7c9-0741bac4430c de-la-Portilla, F. (Fernando)|||/items/c5afd819-79e9-4562-858f-87f4c222dc5e Baixauli-Fons, J. (Jorge)|||/items/c863985d-f450-4807-a4fe-56d26f6e8dfa Garcia-Garcia, J. (Jacinto)|||/items/57fca8ad-e34d-4e81-a9d9-cb1ccd6ea8cc Ramirez, J.M. (José Manuel)|||/items/e5ef340d-f995-4a9b-9168-c1f62eb2026d Sanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49 Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1 |
| author |
García-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5 |
| author_facet |
García-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5 Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998 Herreros, M.D. (María Dolores)|||/items/5f7ca674-900a-4834-a92e-ab5374f1e7d0 Gracia-Solana, J. (José)|||/items/92105c65-715d-4b4e-abe9-95512c92cbcb Guadalajara, H. (Héctor)|||/items/cd73ff10-d4bb-426c-b7c9-0741bac4430c de-la-Portilla, F. (Fernando)|||/items/c5afd819-79e9-4562-858f-87f4c222dc5e Baixauli-Fons, J. (Jorge)|||/items/c863985d-f450-4807-a4fe-56d26f6e8dfa Garcia-Garcia, J. (Jacinto)|||/items/57fca8ad-e34d-4e81-a9d9-cb1ccd6ea8cc Ramirez, J.M. (José Manuel)|||/items/e5ef340d-f995-4a9b-9168-c1f62eb2026d Sanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49 Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1 |
| author_role |
author |
| author2 |
Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998 Herreros, M.D. (María Dolores)|||/items/5f7ca674-900a-4834-a92e-ab5374f1e7d0 Gracia-Solana, J. (José)|||/items/92105c65-715d-4b4e-abe9-95512c92cbcb Guadalajara, H. (Héctor)|||/items/cd73ff10-d4bb-426c-b7c9-0741bac4430c de-la-Portilla, F. (Fernando)|||/items/c5afd819-79e9-4562-858f-87f4c222dc5e Baixauli-Fons, J. (Jorge)|||/items/c863985d-f450-4807-a4fe-56d26f6e8dfa Garcia-Garcia, J. (Jacinto)|||/items/57fca8ad-e34d-4e81-a9d9-cb1ccd6ea8cc Ramirez, J.M. (José Manuel)|||/items/e5ef340d-f995-4a9b-9168-c1f62eb2026d Sanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49 Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1 |
| author2_role |
author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Dadun. Depósito Académico Digital Universidad de Navarra |
| dc.subject.none.fl_str_mv |
Complex cryptoglandular fistula Mesenchymal stem cells Phase III |
| topic |
Complex cryptoglandular fistula Mesenchymal stem cells Phase III |
| description |
The 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. |
| publishDate |
2020 |
| dc.date.none.fl_str_mv |
2020 2020-01-01 2020 2020-01-01 2023 2023-02-20 |
| dc.type.none.fl_str_mv |
journal article http://purl.org/coar/resource_type/c_6501 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/10171/65509 |
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https://hdl.handle.net/10171/65509 |
| dc.language.none.fl_str_mv |
Inglés eng |
| language_invalid_str_mv |
Inglés |
| language |
eng |
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open access http://purl.org/coar/access_right/c_abf2 |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 |
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openAccess |
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application/pdf |
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Wiley |
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Wiley |
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reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra |
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Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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15.300724 |