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| Name | Class |
|---|---|
| Hospital Universitario Fundación JimĆ©nez DĆaz | OTHER |
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Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo EspaƱol de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Therapy | Procedure | Application of Darvadstrocel locally, after fistula tract curettage and internal opening closure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Efficacy of Darvadstrocel-Clinical | Clinical closure of the Fistula | 6 moths |
| Therapeutic Efficacy of Darvadstrocel-MRI | MRI imaging closure of the Fistula | 6 moths |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) | QoL according to dedicated questionnaire (EuroQoL 5D-3L) | 6 moths |
| PATIENT REPORTED OUTCOMES (PROs) | A Dedicated self complementary questionnaire (PROMs) |
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Inclusion Criteria:
Exclusion Criteria:
⢠Patient with recto-vaginal ļ¬stula; rectal or anal stenosis; or active severe proctitis.
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Patiens with perianal Crohn“s Disease who do not respond to current therapies.
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| Name | Affiliation | Role |
|---|---|---|
| Jose-M Ramirez, Prof | Catedra GERM Medicina Perioperatoria | Principal Investigator |
| Damian Garcia-Olmo, Prof | Fundación Jiménez Diaz. Madrid | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Elche | Elche | Alicante | Spain | |||
| HOSPITAL Meixoeiro Vigo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30298387 | Background | Scott LJ. Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn's Disease. BioDrugs. 2018 Dec;32(6):627-634. doi: 10.1007/s40259-018-0311-4. | |
| 28790453 | Background | Panes J, Rimola J. Perianal fistulizing Crohn's disease: pathogenesis, diagnosis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):652-664. doi: 10.1038/nrgastro.2017.104. Epub 2017 Aug 9. |
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| 6 moths |
| Efficiency | Cost-Effectiveness of the procedure | 6 moths |
| Vigo |
| Pontevedra |
| Spain |
| Hospital Vall D“Hebron | Barcelona | Spain |
| Hospital La Fe | Valencia | Spain |
| 29277560 | Background | Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24. |
| 34890373 | Result | Garcia-Olmo D, Gilaberte I, Binek M, D Hoore AJL, Lindner D, Selvaggi F, Spinelli A, Panes J. Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial. Dis Colon Rectum. 2022 May 1;65(5):713-720. doi: 10.1097/DCR.0000000000002325. |
| 27477896 | Result | Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29. |