Secretome bAsed Therapy for complex perianal fistUlas in CRohN’s disease (SATURN)
Financed by : European Comission
Program: HORIZON-HLTH-2025-01-TOOL-02
Project Reference: 101290269
Role in the project: Partner
Duration: October 2026 to September 2031
Contact: Miriam Rol
Implementation Centre: IBIMA Plataforma BIONAND
Research group of IBIMA involved: Unidad de Investigación Clínica Independiente y Ensayos Clínicos de IBIMA Plataforma BIONAND (UICEC-IBIMA Plataforma BIONAND)
ABSTRACT
SATURN aims to demonstrate the safety and efficacy of EVerGel, a mesenchymal stem cell–derived extracellular vesicle–enriched secretome (MSC-EV-Se) therapy, through phase I and II clinical trials in patients with complex perianal fistulas (CPF) in Crohn’s disease.
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.
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.
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 (Université 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).
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
Partners
- EVERZOM, Coordinator
- INSTITUTO INVESTIGACION SANITARIA FUNDACION JIMENEZ DÍAZ (Partner)
- UNIVERSITAETSKLINIKUM ESSEN (Partner)
- Humanitas (Partner)
- CENTRE HOSPITALIER REGIONAL DE MARSEILLE, ASSISTANCE PUBLIQUE-HOPITAUX MARSEILLE (Partner)
- ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (Partner)
- FUNDACION PARA LA INVESTIGACION DE MALAGA EN BIOMEDICINA Y SALUD (Affiliated)
- FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO LA PAZ (Affiliated)
- NANTES UNIVERSITE (Partner)
- CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES (Affiliated)
- INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (Partner)
- Revio Pharmaceutical Consultants S.L. (Partner)
- EUROPEAN FEDERATION OF CROHN’S AND ULCERATIVE COLITIS ASSOCIATIONS (Partner)
- ETABLISSEMENT FRANCAIS DU SANG (Partner)
- INITS SMO (Partner)