Objective
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
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Keywords
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Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
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Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.6 - Health Care Systems
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HORIZON.2.1.5 - Tools, Technologies and Digital Solutions for Health and Care, including personalised medicine
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-RIA - HORIZON Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-HLTH-2025-01
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
75014 Paris
France
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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Participants (15)
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28040 Madrid
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45147 Essen
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20100 Rozzano (Mi)
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13354 Marseille Cedex 20
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75014 Paris
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
41013 Sevilla
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
29590 MALAGA
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
28046 Madrid
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44000 Nantes
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
44093 Nantes
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
75654 Paris
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
28200 MADRID
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
1000 Bruxelles / Brussel
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93210 LA PLAINE SAINT DENIS
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34000 Montpellier
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