Ensayo clínico en fase IIA para evaluar la seguridad y eficacia del tratamiento con células troncales alogénicas mesenquimales derivadas de la grasa en pacientes con estenosis inflamatoria única en el contexto de la Enfermedad de Crohn.
Datos básicos
- Protocolo:
- FJD-MEIC-21-01
- EUDRACT:
- 2021-006068-26
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2023
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Evaluar la factibilidad y seguridad de la administración de adMSCs alogénicas por vía laparoscópica para el tratamiento de pacientes con estenosis inflamatorias intestinales asociadas a la Enfermedad de Crohn. Objetivos Secundarios: Evaluar la eficacia preliminar del tratamiento. Evaluar los cambios en la calidad de vida de los pacientes tratados mediante el cuestionario de IBDQ32.
Documentos
- No hay documentos
Participantes
Financiadores - Promotores
Resultados del Ensayo Clínico
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
Adherence to diagnostic and treatment recommendations for the management of acute severe ulcerative colitis: a prospective and multinational study
Rodriguez-Lago, I.; (...); Gisbert, J. P.
Meeting Abstract. 2024
Are we ready for telemonitoring inflammatory bowel disease? A review of advances, enablers, and barriers.
Del Hoyo, Javier; (...); Aguas, Mariam
Article. 10.3748/wjg.v29.i7.1139. 2023
Baiona's Consensus Statement for Fecal Incontinence. Spanish Association of Coloproctology
Miguel, Javier Cerdan; (...); Mijaiel, Gervasio Salgado
Article. 10.1016/j.ciresp.2023.07.009. 2024
Catalase inhibition can modulate the ability of peripheral blood T cells to undergo apoptosis in Crohn's disease.
Moret-Tatay, Ines; (...); Beltran, Belen
Article. 10.1093/cei/uxad134. 2024
Clinical practice guidelines for diagnostic and therapeutic management of faecal incontinence: Baiona consensus from the Spanish Association of Coloproctology.
Cerdan Miguel, Javier; (...); Salgado Mijaiel, Gervasio
Article. 10.1016/j.cireng.2023.07.008. 2024
Cost of telemonitoring with the App TECCU in Inflammatory Bowel Disease compared to standard care in Spain: a multicenter clinical trial of GETECCU
Aguas Peris, M.; (...); Nos, P.
Meeting Abstract. 10.1093/ecco-jcc/jjae190.0428. 2025
Crossing barriers: the burden of inflammatory bowel disease across Western Europe.
Kumar A; (...); Brookes MJ
Article. 10.1177/17562848231218615. 2023
Early predictors of the need for surgery in patients with acute severe ulcerative colitis: results of the prospective, observational, international ESCP MASC study
Frasson, M.; (...); Pellino, G.
Meeting Abstract. 2023
Effect of the HLA-DQA1*05 allele on the efficacy of ustekinumab in patients with Crohn's Disease. Multicenter study based on the ENEIDA registry of GETECCU.
Guardiola Capon, J.; (...); Rodriguez-Moranta, F.
Meeting Abstract. 2024
Efficacy of Beclomethasone Dipropionate in Lowering Fecal Calprotectin Levels in Patients with Ulcerative Colitis in Clinical Remission and at Risk of Relapse: The Becalcu Randomized, Controlled Trial.
Ginard, Daniel; (...); Sans, Miquel
Article. 10.1159/000540792. 2024
Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.
Loras C; (...); Esteve M
Article. 10.1186/s13063-023-07447-1. 2023
European Society of Coloproctology: Guidelines for diagnosis and treatment of cryptoglandular anal fistula
Reza, Lillian; (...); Zimmerman, David
Article. 10.1111/codi.16741. 2024
Evaluation of tolerance to mercaptopurine in patients with inflammatory bowel disease and gastrointestinal intolerance to azathioprine.
Article. 10.1016/j.gastrohep.2023.12.001. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Ileal Predominance in Crohn's Disease Is Associated With Increased Intestinal Surgery and Biological Therapy Use, With Lower Treatment Persistence
Giordano, Antonio; (...); ENEIDA project of GETECCU
Article. 10.14309/ajg.0000000000003207. 2025
Immunoepigenetic Regulation of Inflammatory Bowel Disease: Current Insights into Novel Epigenetic Modulations of the Systemic Immune Response.
Bastida, Guillermo; (...); Moret-Tatay, Ines
Article. 10.3390/genes14030554. 2023
Impact of Anti-CD20 therapies on the immune homeostasis of gastrointestinal mucosa and their relationship with de novo intestinal bowel disease in multiple sclerosis: a review.
Quesada-Simo, A.; (...); Gil-Perotin, S.
Article. 10.3389/fphar.2023.1186016. 2023
Impact of telemonitoring on the management of Inflammatory Bowel Disease in Spain: a multicenter TECCU clinical trial
Peris, M. Aguas; (...); Nos, P.
Meeting Abstract. 2023
Influence of familial forms of inflammatory bowel disease on the use of immunosuppressants, biological agents, and surgery in the era of biological therapies. Results from the ENEIDA project.
Gonzalez-Munoza, Carlos; (...); Domenech, Eugeni
Article. 10.1093/postmj/qgae076. 2024
Is the withdrawal of anti-tumour necrosis factor in inflammatory bowel disease patients in remission feasible without increasing the risk of relapse? Results from the randomised clinical trial of GETECCU (EXIT)
Chaparro, M.; (...); Gisbert, J. P.
Meeting Abstract. 2023
Leishmania infection in patients with inflammatory bowel disease: Case series and literature review.
Gimeno-Pitarch L, Almela P, Nos P
Article. 10.1016/j.gastrohep.2023.04.001. 2024
Long-term impact of early medical prevention of postoperative recurrence on second intestinal resections in patients with Crohn's Disease. Data from the ENEIDA registry
Pinero, G. S.; (...); Domenech, E.
Meeting Abstract. 10.1093/ecco-jcc/jjae190.0794. 2025
Long-term treatment outcomes of complicated acute diverticulitis in immunocompromised patients.
Sancho-Muriel, Jorge; (...); Flor-Lorente, Blas
Article. 10.1007/s00384-024-04753-1. 2024
MicroRNA and granulocyte-monocyte adsorption apheresis combotherapy after inadequate response to anti-TNF agents in ulcerative colitis.
Saez-Gonzalez, Esteban; (...); Beltran, Belen
Article. 10.1002/jca.22101. 2023
Multicentre, prospective, randomized control non-inferiority trial of bladder catheter management in colon surgery
Serra-Aracil, Xavier M.; (...); Mora-Lopez, Laura
Article. 10.1111/codi.16593. 2023
Multicriteria Decision Analysis for Updating of Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units in Spain.
Calvet X; (...); Barreiro-de Acosta M
Article. 10.1093/ecco-jcc/jjac068. 2022
Need for therapeutic escalation in patients with refractory ulcerative proctitis: Results from the PROCU study of the ENEIDA registry.
Ferreiro-Iglesias, Rocio; (...); Barreiro-de Acosta, Manuel
Article. 10.1111/apt.18133. 2024
New surgical techniques and strategies for Crohn's disease: results vs expectations
Pellino, Gianluca, Scheiding, Monica Millan
Article. 10.1016/j.ciresp.2024.04.014. 2024
New surgical techniques and strategies for Crohns disease: results vs expectations.
Pellino, Gianluca, Millan Scheiding, Monica
Article. 10.1016/j.cireng.2024.04.017. 2024
Optimization through iv maintenance with ustekinumab in Inflammatory Bowel Disease. Efficacy and adjusted regimen in real world
Minguez, A.; (...); Bastida, G.
Meeting Abstract. 2024
Optimizing outcomes with maintenance IV UST in highly bio-exposed patients with IBD. Efficacy and adjusted regimen in real world.
Minguez, Alejandro; (...); Bastida, Guillermo
Article. 10.1016/j.gastrohep.2024.502253. 2024
Patterns and predictors of postoperative complications and recurrence after ileocecal resection for Crohn's disease: a national multicenter longitudinal study.
Soler-Silva, A; (...); Millan, M
Article. 10.1007/s10151-024-03054-7. 2025
Personalised therapy in inflammatory bowel disease
Calderón P; (...); Quera R
Article. 10.1016/j.gastrohep.2023.12.006. 2024
Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis on sexuality and inflammatory bowel disease.
Calvo Moya M; (...); Gutiérrez Casbas A
Article. 10.1016/j.gastrohep.2023.12.013. 2024
Prevention of postoperative recurrence of Crohn's disease with vedolizumab: First results of the prospective placebo-controlled randomised trial REPREVIO
D'Haens, G.; (...); Laharie, D.
Meeting Abstract. 2023
Psoriasis induced by antiTNF therapy in inflammatory bowel disease: Therapeutic management and evolution of both diseases in a nationwide cohort study.
Sanz Segura, Patricia; (...); Garcia-Lopez, Santiago
Article. 10.1016/j.dld.2024.05.021. 2024
Real life 2 year experience with ustekinumab in a Spanish open-label cohort of ulcerative colitis patients.
Iborra Colomino, M. I.; (...); Nos, P.
Meeting Abstract. 2023
Real-world effectiveness of vedolizumab in managing refractory pouchitis: a multicenter study on intravenous to subcutaneous transition
Gimeno-Pitarch, L.; (...); Iborra, M.
Meeting Abstract. 10.1093/ecco-jcc/jjae190.1018. 2025
Real-world long-term effectiveness of ustekinumab in ulcerative colitis: results from a spanish open-label cohort.
Iborra, Marisa; (...); Nos, Pilar
Article. 10.1080/00365521.2023.2278427. 2023
Resistance to apoptosis in complicated Crohn's disease: Relevance in ileal fibrosis
Seco-Cervera M; (...); Barrachina MD
Article. 10.1016/j.bbadis.2023.166966. 2024
Results of the national registry of patients diagnosed with inflammatory bowel disease candidates for bariatric surgery (ReNacEIBar).
Ferrer-Márquez M; (...); Tarascó Palomares J
Article. 10.1016/j.cireng.2023.05.018. 2024
Role of Interleukin-8 in Predicting Long-Term Response to Vedolizumab in Ulcerative Colitis Patients
Minguez, A.; (...); Nos, P.
Meeting Abstract. 10.1093/ecco-jcc/jjae190.1111. 2025
Subcutaneous infliximab cut-off points in a large cohort of Spanish patients with inflammatory bowel disease and factors associated with long-term outcomes
Iborra, M.; (...); Nos, P.
Meeting Abstract. 2024
Subcutaneous infliximab cut-off points in patients with inflammatory bowel disease. Data from the ENEIDA registry.
Article. 10.1093/ecco-jcc/jjae127. 2024
Surgery for inflammatory bowel disease in Spain: How are we doing? Initial results of a nationwide prospective registry
Sanchez-Guillen, L.; (...); Millan, M.
Article. 10.1016/j.ciresp.2023.08.001. 2024
Surgery for inflammatory bowel disease in Spain: How are we doing? Initial results of a nationwide prospective registry.
Sanchez-Guillen, L; (...); Millan, M
Article. 10.1016/j.cireng.2023.08.001. 2024
Switching to standard-dose subcutaneous vedolizumab increases the percentage of patients in biochemical remission even in those intensified with intravenous vedolizumab: one year results of a Spanish multicentre observational study
Andres Pascual, L.; (...); Sicilia, B.
Meeting Abstract. 10.1093/ecco-jcc/jjae190.1000. 2025
Telemonitoring with TECCU of active Inflammatory Bowel Disease is Not Inferior to Standard Care: Short-term Results of a Multicentre Randomized Controlled Trial of GETECCU.
Article. 10.2196/60966. 2024
The Risk of Developing Disabling Crohn's Disease: Validation of a Clinical Prediction Rule to Improve Treatment Decision Making
Bastida Paz, Guillermo; (...); Nos, Pilar
Article. 10.1159/000531789. 2023
Therapeutic drug monitoring during induction therapy with Ustekinumab in patients with Crohn's disease: the key to early identification of patients with inadequate response
Minguez, A.; (...); Nos, P.
Meeting Abstract. 2023
Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study).
Herreros, Maria Dolores; (...); Garcia-Olmo, Damian
Article. 10.1097/DCR.0000000000003216. 2024
Ustekinumab and vedolizumab as first-line biological therapy for inflammatory bowel disease. A multicenter study based on the ENEIDA registry.
Sard, M. Calafat; (...); Domenech, E.
Meeting Abstract. 2023
Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry.
Manosa, Miriam; (...); Domenech, Eugeni
Article. 10.1016/j.dld.2022.07.013. 2022
Vedolizumab to prevent postoperative recurrence of Crohn's disease (REPREVIO): a multicentre, double-blind, randomised, placebo-controlled trial.
D'Haens, Geert; (...); Laharie, David
Article. 10.1016/S2468-1253(24)00317-0. 2025