{"id":63160,"date":"2026-11-10T17:58:11","date_gmt":"2026-11-10T17:58:11","guid":{"rendered":"https:\/\/ibima.eu\/?p=63160"},"modified":"2026-11-10T18:22:06","modified_gmt":"2026-11-10T18:22:06","slug":"saturn-eu","status":"publish","type":"post","link":"https:\/\/ibima.eu\/es\/saturn-eu\/","title":{"rendered":"SATURN"},"content":{"rendered":"

[et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbSecretome bAsed Therapy for complex perianal fistUlas in CRohN\u2019s disease (SATURN)\u00bb _builder_version=\u00bb4.27.7″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_align=\u00bbcenter\u00bb title_text_color=\u00bb#0C71C3″ module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb2_3,1_3″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb30px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb2_3″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.27.7″ _module_preset=\u00bbdefault\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″]<\/p>\n

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Financed by<\/span><\/strong> : European Comission<\/span><\/span><\/span><\/p>\n

Program<\/strong>: HORIZON-HLTH-2025-01-TOOL-02<\/span><\/p>\n

Project Reference: <\/b>101290269<\/span><\/span><\/p>\n

Role in the project:<\/strong> Partner<\/span><\/p>\n

Duration:<\/b> October 2026 to September 2031<\/span><\/p>\n

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Contact: Miriam Rol<\/span><\/p>\n

Implementation Centre: IBIMA Plataforma BIONAND<\/a><\/span><\/p>\n

Research group of IBIMA involved: Unidad de Investigaci\u00f3n Cl\u00ednica Independiente y Ensayos Cl\u00ednicos de IBIMA Plataforma BIONAND (UICEC-IBIMA Plataforma BIONAND)<\/a><\/span><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb||-48px||false|false\u00bb custom_padding=\u00bb50px||50px||true|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbABSTRACT\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_color=\u00bb#0C71C3″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][et_pb_text _builder_version=\u00bb4.27.7″ _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb0px||19px||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n

SATURN aims to demonstrate the safety and efficacy of EVerGel, a mesenchymal stem cell\u2013derived extracellular vesicle\u2013enriched secretome (MSC-EV-Se) therapy, through phase I and II clinical trials in patients with complex perianal fistulas (CPF) in Crohn\u2019s disease.<\/p>\n

EVerGel is a dual formulation of MSC-EV-Se: a PBS solution injected subcutaneously to modulate perilesional inflammation, and injected in a thermosensitive intraluminal hydrogel to support tract closure, ensure optimal biodistribution? and provide sustained drug release. This approach aims to improve healing in CPF refractory to anti-TNF therapies. Multicenter, randomized, placebo-controlled phase I and II clinical trials will be conducted in France, Spain, and Italy.<\/p>\n

The project addresses key bottlenecks of secretome-based therapies. A GMP-compliant, scalable, and standardized manufacturing process has already been established for clinical batches, and a potency testing matrix will be created through characterization of bioactive factors. Longitudinal analyses of patient biopsies and fluids with multi-omics, imaging, and functional assays will map immune modulation and tissue repair pathways, offering insights into the mode of action and informing future patient stratification.<\/p>\n

To achieve these objectives, a 15-partner consortium across 5 European countries (France, Spain, Germany, Italy, and Belgium), coordinated by EVerZom (France), gathers leading clinical centers (II-FJD Madrid, ICH Milan, AP-HM Marseille), EV\/secretome research labs (Universit\u00e9 de Nantes, Univ. of Essen), manufacturing experts (EFS and INITS, France), a clinical operations network (ECRIN, France), a patient association (EFFCA, Belgium), and a regulatory CRO (Revio, Spain).<\/p>\n

The project will deliver a standardized, regulatory-ready secretome product with initial clinical validation, interoperable assays, and reference materials, and a clear path to phase III evaluation in a high-burden indication<\/p>\n

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