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Grant Analysis

Purpose & Target

The core objective of this grant is to advance cell secretome-based therapies by funding projects that conduct comprehensive clinical trials (Phase 1 and 2) to demonstrate their safety and efficacy for human use. The grant specifically aims to overcome current bottlenecks in understanding, reproducibility, and standardization of these therapies.

Explicit identification of target recipient type and size: Legal entities capable of conducting advanced biomedical research and clinical trials, including biopharmaceutical developers, research institutions, universities, and Small and Medium-sized Enterprises (SMEs).
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Health, Biotechnology, Regenerative Medicine)
Geographic scope and any location requirements: Projects must be based in EU Member States, Horizon Europe Associated Countries, or the United States of America. Applications require an international consortium.
Key filtering criteria for initial grant screening:
Focus on human cell secretome-based therapies.
Inclusion of Phase 1 and Phase 2 clinical trials.
Demonstrated plan for GMP-conform (Good Manufacturing Practice) production.
Project must be undertaken by an interdisciplinary consortium.
Grant frequency and program context: This grant is part of the Horizon Europe Work Programme 2025, specifically under Cluster 1 - Health. It is a recurring type of call within the annual work programmes.

Financial Structure

Total budget allocated for this topic (HORIZON-HLTH-2025-01-TOOL-02) for the year 2025 is 40,000,000 EUR.
Minimum grant amount per project: 9,000,000 EUR.
Maximum grant amount per project: 13,000,000 EUR.
Currency: EUR.
Expected number of grants to be awarded under this topic: 3.
The funding rate for Research and Innovation Actions (RIA) under Horizon Europe is typically 100% of eligible costs, though this specific percentage is not explicitly detailed in the provided document.
Financial and operational capacity requirements for applicants are described in Annex C of the Horizon Europe Work Programme General Annexes, which is a standard reference for all Horizon Europe grants.

Eligibility Requirements

Organization Type and Structure

Any legal entity established in the United States of America is eligible to receive Union funding.
Legal entities from EU Member States and Horizon Europe Associated Countries (as described in Annex B of the Work Programme General Annexes) are eligible.
SMEs (Small and Medium-sized Enterprises) are strongly encouraged to participate.
The Joint Research Centre (JRC) may participate as a member of the consortium selected for funding.
A consortium is required, involving a broad spectrum of actors from different sectors.
Entities assessed as “high-risk suppliers” of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities, and associated partners.

Technical and Capacity Requirements

Demonstrated capability to conduct interventional randomised controlled clinical trials (Phase 1 and 2).
Capacity for GMP-conform (Good Manufacturing Practice) production processes.
Expertise in biomedical research, regenerative medicine, standardized analytical methods, computational approaches, organoids, and organ-on-chips is expected.
The selected secretome-based therapy must have its main mechanism of action elucidated in in-vitro and/or in-vivo models prior to the project start.
The selected secretome or its chosen bio-active components (e.g., extracellular vesicles, trophic factors, organelles, RNA, proteins, peptides) must have been characterized, and its therapeutic activity must have already been demonstrated in relevant pre-clinical models.

Project Specifics

The secretome or its parts must be derived from human cells.
The therapeutic effect must stem from the secretome's endogenous capabilities and functionalities; exogenous loading with drugs (using the secretome or its components as a drug carrier) is not within the scope of this grant.
If an engineering step is included, modifications to the secretome or bioactive component must not involve genetic modification of the parent cells, nor should they alter the main mechanism of action. The modified therapy must also remain within the boundaries of substances of human origin.
Proposals must explicitly take sex differences into consideration, both concerning the parent cells used and for the targeted therapeutic application.

Application Process

Application Submission

Application deadline: 2025-09-16.
Submission session open: Applications have been accepted since 2025-05-22.
Submission format: Proposals are processed through a single-stage submission procedure.
Submission platform: Applications must be submitted via the Funding & Tenders Portal Submission System.

Required Documentation

A standard application form (HE RIA, IA) is required, which is available directly within the Submission System.
A dedicated annex for clinical studies must be completed. Applicants are strongly encouraged to use the template provided in the submission system for this purpose.

Project Milestones and Deliverables

Applicants are expected to deliver documentation needed for GMP-conform production (e.g., Standard Operating Procedures - SOPs) no later than month 12 of the project.
Documentation needed for the conduct of the clinical trial (e.g., Investigational Medicinal Product Dossier - IMDP) must be delivered no later than month 24, enabling the regulatory approval necessary to start the clinical trial.
The overarching goal is to fully perform and finalize Phase 1 and Phase 2 clinical trials within the project's lifetime and subsequently work towards achieving market authorization for the proposed secretome-based therapy.

Support and Guidance

Online Manual: Provides comprehensive guidance on procedures from proposal submission to grant management.
Horizon Europe Programme Guide: Offers detailed insights into the structure, budget, and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ: A resource for frequently asked questions regarding proposal submission, evaluation, and grant management.
Research Enquiry Service: For general questions about European research and EU Research Framework Programmes.
National Contact Points (NCPs): Provide country-specific guidance, practical information, and assistance on participation in Horizon Europe, including for non-EU and non-associated countries.
Enterprise Europe Network (EEN): Offers advice to businesses, with a special focus on SMEs, including guidance on EU research funding.
IT Helpdesk: Available for technical issues related to the Funding & Tenders Portal, such as forgotten passwords, access rights, and technical aspects of proposal submission.
European IPR Helpdesk: Assists with intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk: European Standards Organisations that advise on integrating standardization into project proposals.
The European Charter for Researchers and the Code of Conduct for their recruitment: Outlines general principles and requirements for researchers, employers, and funders.
Partner Search: A tool to help applicants find suitable partner organizations for their consortium.

Evaluation Criteria

Scoring Thresholds

Excellence: Threshold of 4
Impact: Threshold of 4
Implementation: Threshold of 4
Cumulative Threshold for all criteria: 12

Excellence Criteria

Scientific and technological quality: This includes the soundness of the research methodology and approach, particularly the robust design and execution plan for the Phase 1 and 2 clinical trials.
Clarity of objectives: The proposal should clearly define objectives that demonstrate significant progress beyond the current state-of-the-art in secretome-based therapies.
Quality of the consortium: Assessed based on the expertise, complementarity of skills among partners, and the effectiveness of the proposed management structure.
Understanding of mechanism of action: The proposal must include a clear plan for elucidating the mode of action and ensuring the reproducibility and quality assurance of the secretome-based therapies.
Ethical and regulatory considerations: Attention to these aspects from the project's inception, including compliance with relevant authorities.

Impact Criteria

Contribution to societal health: How the project contributes to developing and using new tools, technologies, and digital solutions for a healthy society.
Patient outcomes: Expected improvements in patient outcomes, disease prevention, diagnosis, treatment, and monitoring through safer, more sustainable, efficient, cost-effective, and affordable therapies.
European leadership: Strengthening Europe's scientific and technological expertise and leadership in health technology development.
Disease burden reduction: Potential for reducing the burden of diseases through innovative diagnostic and therapeutic approaches.
Healthcare efficiency: Improvement of health research and innovation productivity and the quality of healthcare through the ethical and secure use of health data and analytical tools (e.g., AI).
Public trust: Fostering citizen trust and support for innovative technologies in healthcare based on expected health outcomes and risk assessment.
Market pathway: A clear pathway towards standardized manufacturing processes and market authorization is expected.
First deployment: If an exploitation strategy is developed, there must be a commitment to first deployment in the EU.

Implementation Criteria

Work plan coherence: The coherence and effectiveness of the proposed work plan, including the appropriateness of allocated resources.
Management quality: The quality and capacity of the project's management structure.
Resource allocation: Appropriate allocation of tasks and resources among consortium members.
Risk management: Robust risk management and mitigation strategies for technical, ethical, and regulatory challenges.
Milestone delivery: Feasibility of timely delivery of key documentation, specifically GMP-conform production documentation (by month 12) and clinical trial documentation (by month 24).
Trial completion: The feasibility of completing Phase 1 and Phase 2 clinical trials within the project's lifetime.

Compliance & Special Requirements

Regulatory and Ethical Compliance

Strict adherence to all regulatory and ethical approvals required for conducting clinical studies is mandatory.
Compliance with all requirements of the relevant competent authorities throughout the project lifecycle.
Production processes for the secretome-based therapies must be GMP-conform (Good Manufacturing Practice).
Any modifications to the secretome or its bioactive components must ensure the proposed therapy remains within the boundaries of substances of human origin.
Projects must comprehensively address ethical, legal, and regulatory considerations in their design and implementation, ensuring secure, ethically sound, and inclusive delivery of solutions.
If projects utilize satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS services.

Project-Specific Requirements and Preferences

Preference is given to proposals targeting diseases, dysfunctions, or health impairments that affect larger patient populations and/or represent a high burden on public health systems.
Proposals must explicitly include consideration of sex differences both concerning the parent cells used for secretome production and the targeted therapeutic application.
The involvement of the European Commission's Joint Research Centre (JRC) is encouraged, as they can serve as a potential interface between research activities and pre-normative regulatory science, including the validation of test methods.
Cooperation between EU-funded projects is strongly welcomed and supported to facilitate cross-fertilisation, knowledge exchange, best practice development, and other synergies.

Exclusions and Strategic Alignment

Entities assessed as “high-risk suppliers” of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities, or associated partners.
Projects should strategically align with and contribute to the objectives of key EU policies, including the Biotechnology and Biomanufacturing Strategy and the Artificial Intelligence Strategy.
The grant aims to support objectives of the Strategic Technologies for Europe Platform (STEP), which seeks to boost investments in critical technologies within Europe.

Grant Details