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Call key data

Advancing cell secretome-based therapies

Funding Program

Horizon Europe: Cluster 1 - Health

Call number

HORIZON-HLTH-2025-01-TOOL-02

deadlines

Opening
22.05.2025

Deadline
16.09.2025 17:00

Funding rate

100%

Call budget

€ 40,000,000.00

Estimated EU contribution per project

between € 9,000,000.00 and € 13,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

short description

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”.

Call objectives

Secretome-based therapies have emerged as a promising alternative to cell-based therapies. The secretome of cells is defined as the repertoire of molecules and biological factors that are secreted into the extracellular space and has been shown to be a key factor for therapeutic activity due to its paracrine effects. The potential to manufacture, store and use secretome factors as off-the-shelf products, while maintaining the therapeutic benefits of cells but with fewer safety concerns, has placed the secretome at the forefront of regenerative medicine. Different cell secretomes or parts thereof have been the subject of clinical trials, but there is currently no regulatory-approved secretome-based therapy owing to several challenges. Currently, for the majority of secretome-based therapies, the main bottlenecks are: the incomplete understanding of their mode of action, their reproducibility due to a lack of standardised manufacturing processes and a lack of potency- and quality assurance assays. Additional limitations are the characterisation of the bioactive factors and the optimisation of the delivery strategies.

Proposals submitted under this topic should tackle the above-mentioned issues and pave the way to secretome-based therapies that are safe, efficacious, and regulatory-approved for human use. The activities should cover secretomes or their parts that are derived from human cells and comprise all the following elements:

  • The selection of a secretome-based therapy whose main mechanism of action has been elucidated in in-vitro and/or in-vivo models prior to the start of the proposed work. The selected secretome or its chosen bio-active components (extracellular vesicles, trophic factors, organelles, RNA, proteins, peptides, etc.), including those that are potentially harmful, should have been characterised and its/their therapeutic activity should already have been demonstrated in relevant pre-clinical models. All types of human cells may be used as underlying parent cells.
  • All activities that are necessary to ensure regulatory and ethical approvals enabling the conduct of the clinical study. This may comprise the full characterisation, standardised analytical methods, further pre-clinical studies in relevant models (pertinent to the targeted disease or disorder) and appropriate quality assurance assays including computational approaches, organoids and organ-on chips/microfluidic systems.
  • Establishment of a manufacturing protocol for the selected secretome or its components, including all the steps of the biogenesis: parent cells selection, their pre-conditioning and bio-processing (isolation, expansion, cultivation in bioreactors), processing of the conditioned media, the extraction of the secretome or its components (isolation, purification, storage, distribution) and its/their delivery to target site in the human body (mode of administration, final formulation).
  • Definition of relevant quality criteria for and establishment of a fully GMP-conform production process that enables to carry out clinical trials of the proposed secretome-based therapy.
  • Carrying out of all the above-mentioned activities in close interaction with and in compliance with all requirements of the relevant competent authorities, allowing to perform clinical trials.
  • Conduct of an interventional randomised controlled clinical trial comprising phase 1 and phase 2 to generate scientific evidence demonstrating safety and efficacy of the proposed secretome-based therapy.
  • Applicants are expected to deliver no later than at month 12 of the project the documentation needed for the GMP-conform production (e.g. SOP - Standard Operating Procedures) and no later than at month 24 the documentation needed for the conduct of the clinical trial (e.g. IMDP), enabling to get the regulatory approval for the clinical trial. The overall goal is to perform and finalise the phase 1 and phase 2 clinical trials during the lifetime of the project and further achieve authorization of the proposed secretome-based therapy.
  • Optionally and if essential for the chosen secretome-based therapy, the work should also include an engineering step of the secretome to achieve the desired profile for increased safety and improved therapeutic effect. To this end, the secretome or its bioactive component(s) may be modified either pre- or post-biogenesis, by use of classical methods on the parent cells, except their genetic modification, or by physico-chemical modification of the bio-active secretome component. The effected modifications of the secretome should lead to the improvement of the functional properties/features and/or of the delivery to target site (organ, tissue, etc.) for the bioactive secretome component. All these modifications should not alter the main mechanism of action and retain the proposed secretome-based therapy within the boundaries of substances of human origin. The therapeutic effect of the secretome or its components should come from its/their endogenous capabilities and functionalities; exogenous loading with drugs (using the secretome or its components as drug carrier), be it pre- or post-biogenesis, is not in scope.

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Expected effects and impacts

All types of diseases, dysfunctions or health impairments may be targeted, preference should be given to conditions that affect larger patient populations and/or represent a high burden on public health systems.

Sex differences should be taken into consideration, both with regard to the parent cells and for the targeted therapeutic application. Participation of small and medium-sized enterprises (SMEs) is strongly encouraged and if an exploitation strategy is developed, it should commit to a first deployment in the EU.

Proposals should consider the involvement of the European Commission's Joint Research Centre (JRC) as a potential interface between research activities and pre-normative regulatory science and in relation to the potential validation of test methods fit for regulatory purpose. In that respect, the JRC will consider collaborating with any successful proposal and this collaboration, when relevant, should be established after the proposal’s approval.

Applicants should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.

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Expected results

Proposals under this topic should aim to deliver results directed towards and contributing to several of the following expected outcomes:

  • Researchers and biopharmaceutical developers work together with clinicians striving to translate innovative therapeutic approaches into healthcare solutions.
  • Producers of innovative health technologies use standardised manufacturing processes.
  • Healthcare providers get access to a new type of innovative therapies with demonstrated health benefits as compared to traditional treatments.
  • Patients benefit from innovative therapies for conditions for which there are currently no or only insufficient therapeutic strategies.
  • Health systems ultimately benefit from improved patient outcomes, superior to the current standard of care.

Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Canada, Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), New Zealand (Aotearoa), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom

eligible entities

EU Body, Education and training institution, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

Yes

Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • countries associated to Horizon Europe - see list of particpating countries

Only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:

  • at least one independent legal entity established in a Member State; and
  • at least two other independent legal entities, each established in different Member States or Associated Countries.

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

other eligibility criteria

Specific cases:

  • Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • Legal entities created under EU law (EU bodies) including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • International European research organisations are eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’ actions or when provided for in the specific call/topic conditions. Other international organisations are not eligible to receive funding, unless provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.
  • Joint Research Centre (JRC)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.
  • EU restrictive measures — Entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) as well as Article 75 TFEU, are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any).
  • Legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine — Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, there is currently no appropriate context allowing the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine. Therefore, even where such entities are not subject to EU restrictive measures, such legal entities are not eligible to participate in any capacity. This includes participation as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any). Exceptions may be granted on a case-by-case basis for justified reasons.
    With specific regard to measures addressed to Russia, following the adoption of the Council Regulation (EU) 2024/1745 of 24 June 2024 (amending Council Regulation (EU) No 833/2014 of 31 July 2014) concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine, legal entities established outside Russia but whose proprietary rights are directly or indirectly owned for more than 50% by a legal person, entity or body established in Russia are also not eligible to participate in any capacity.
  • Measures for the protection of the Union budget against breaches of the principles of the rule of law in Hungary — Following the Council Implementing Decision (EU) 2022/2506, as of 16 December 2022, no legal commitments can be entered into with Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain. Affected entities may continue to apply to calls for proposals and can participate without receiving EU funding, as associated partners, if allowed by the call conditions. However, as long as the Council measures are not lifted, such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc.).In case of multi-beneficiary grant calls, applicants will be invited to remove or replace that entity in any funded role and/or to change its status into associated partner. Tasks and budget may be redistributed accordingly.

Additional information

Topics

Health, Social Services, Sports

Relevance for EU Macro-Region

EUSDR - EU Strategy for the Danube Region, EUSBSR - EU Strategy for the Baltic Sea Region, EUSALP - EU Strategy for the Alpine Space, EUSAIR - EU Strategy for the Adriatic and Ionian Region

UN Sustainable Development Goals (UN-SDGs)

Additional Information

Applications must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Applications must be submitted using the forms provided inside the electronic submission system (not the templates available on the topic page, which are only for information). The structure and presentation must correspond to the instructions given in the forms.

Applications must be complete and contain all parts and mandatory annexes and supporting documents.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 45 pages.

 

Call documents

Horizon Europe Work Programme 2025 Cluster 1 - HealthHorizon Europe Work Programme 2025 Cluster 1 - Health(1200kB)

Contact

National Contact Points for Horizon Europe
Website

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