Leveraging Europe's Expertise to accelerate Cell Therapy for Type 1 Diabetes

The Innovative Health Initiative Joint Undertaking (IHI JU) is offering a grant opportunity titled "Leveraging Europe's Expertise to Accelerate Cell Therapy for Type 1 Diabetes." This initiative seeks to advance beta-cell replacement therapy as a functional cure for Type 1 Diabetes (T1D). This call supports collaborative research projects under the Horizon Europe program and has a total budget of EUR 37.2 million for various topics, with an indicative expectation of funding one project for EUR 8.8 million.

Eligible applicants include universities, research organizations, patient organizations, small and medium-sized enterprises (SMEs), and mid-sized companies. Larger companies may participate but are generally required to contribute resources. Importantly, legal entities from the UK and Canada are excluded from eligibility for this call.

The application process is structured in two stages: a short proposal with a 20-page limit is due by October 9, 2025, and a full proposal with a 50-page limit is due by April 29, 2026. The grants aim to support projects that tackle key challenges in beta-cell therapies, encouraging collaborations across academia, industry, and healthcare sectors.

The primary target sector is biotech/medtech, focusing on cell therapy for T1D and aligning with EU health policies. Projects should be in the research and development stage, addressing areas such as manufacturing, regulatory processes, clinical integration, and reimbursement strategies. The call emphasizes patient-centered outcomes and real-world evidence.

The expected impacts include furthering the adoption of beta-cell therapy, fostering Europe's leadership in regenerative medicine, and improving healthcare quality and accessibility. Key objectives revolve around establishing standardized frameworks for manufacturing and clinical trials, developing immune-modulating strategies, and integrating cell therapies into diabetes care.

Furthermore, the funding conditions require industry partners to contribute at least 45% of the total project costs. Successful applicants will be supported in creating innovative treatment models that improve patient outcomes and healthcare efficiencies while ensuring ethical standards and data privacy are respected.

Overall, this funding opportunity represents a significant effort to make advances in the treatment of Type 1 Diabetes through collaborative and innovative solutions in cell therapy, enhancing Europe's position in this vital area of healthcare.

The Innovative Health Initiative (IHI) JU Call 11, specifically topic HORIZON-JU-IHI-2025-11-04-two-stage, titled "Leveraging Europe's Expertise to accelerate Cell Therapy for Type 1 Diabetes," is a Research and Innovation Action (RIA) aiming to advance beta-cell replacement therapy as a functional cure for Type 1 Diabetes (T1D). This call is part of the Horizon Europe program and is implemented through a two-stage submission process. The call opens on June 17, 2025, with deadlines for the first stage on October 9, 2025, and for the second stage on April 29, 2026. The total budget allocated to this topic is EUR 37,209,000, with an indicative expectation of funding one project.

The expected impacts of this action are substantial, aiming to support the widespread adoption of beta-cell therapy, accelerate the development of stem cell-based therapies, strengthen Europe’s position as a leader in beta-cell therapy, advance regenerative medicine for other metabolic and autoimmune disorders, improve treatments and guidelines for patients and healthcare providers, and boost European industrial competitiveness. These impacts align with the IHI JU's objectives of improving healthcare quality, accessibility, and sustainability, and contribute to various EU policies and initiatives, including the European Health Union, the Pharmaceutical Strategy for Europe, the EU political priority to boost European competitiveness, the UN Sustainable Development Goals (SDG 3), the European Health Data Space Regulation (EHDS), and the EU Artificial Intelligence Act.

The expected outcomes of the action are comprehensive and aim to benefit various stakeholders. These outcomes include: a standardized framework for impurity thresholds and manufacturing best practices, validated immune-modulating strategies, established scalable and cost-effective manufacturing processes, improved preclinical models and clinical criteria, AI-driven predictive models and real-time monitoring technologies, patient-centered clinical endpoints, cost-effectiveness assessments and reimbursement frameworks, training programs for healthcare providers, and fully operational European innovation hubs.

The scope of the action addresses the challenges and background of T1D, an autoimmune disease that leads to lifelong insulin dependence. Beta-cell replacement therapy offers a promising path towards a functional cure, but critical challenges must be addressed. The key objectives of this action include:

1. Establishing standardized criteria and analytical methods to detect, quantify, and characterize unintended bystander cells and impurities in stem cell-derived or beta-cell therapies for T1D.
2. Enhancing graft survival and immune tolerance by developing immune-modulating strategies and identifying novel biomarkers.
3. Advancing manufacturing and quality control by establishing robust cryopreservation techniques and optimising scalable, cost-effective manufacturing methodologies.
4. Streamlining preclinical and clinical development by enhancing preclinical models and optimising clinical trial design.
5. Implementing advanced monitoring and artificial intelligence (AI)-driven predictive tools to assess transplant success and metabolic function.
6. Defining clinically meaningful and patient-centred endpoints using real-world evidence to capture quality of life and disease burden in T1D.
7. Exploring reimbursement models for beta-cell therapies by developing initial cost-effectiveness models and collaborating with health technology assessment (HTA) bodies.
8. Integrating cell therapy into diabetes care and collaborative networks through specialised training for healthcare providers and the creation of a network of multidisciplinary centres across Europe.

Additional key considerations for applicants include: a sustainability plan for the maintenance, update, and validation of the project's results; consideration of the potential regulatory impact of the results; ensuring transparent and open dissemination of outcomes; and giving adequate consideration in the ethical standards and data privacy frameworks applicable to the use of personal health data and biobanks.

The action is also expected to explore synergies with complementary initiatives such as NHPIG, the Vanguard-project, the Islet-project, JOIN4ATMP, relevant Horizon 2020/Europe projects, and the European Pancreas and Islet Transplantation Registry (EPITR).

The admissibility conditions include proposal page limits of 20 pages for RIA short proposals at stage 1 and 50 pages for RIA full proposals at stage 2. Eligible countries are described in Annex B of the Work Programme General Annexes, and specific provisions may be available for non-EU/non-Associated Countries. Other eligibility conditions are described in Annex B of the Work Programme General Annexes and in the “Conditions of the Calls for proposals and Call management rules” section of the IHI JU Work Programme (WP). Financial and operational capacity and exclusion criteria are described in Annex C of the Work Programme General Annexes.

The evaluation and award process, submission and evaluation processes, and indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes and the Online Manual. The legal and financial set-up of the grants is described in Annex G of the Work Programme General Annexes.

Specific conditions include that legal entities established in the UK and Canada are not eligible to receive funding for this topic. Specific conditions on Availability, Accessibility and Affordability (3A) do not apply to this topic, and the JU retains the right to object to transfer/exclusive licensing.

Relevant documents include templates of the reference documents and associated guidance, which can be found on the IHI JU website. Application forms, templates, and annexes are available for download in the submission system of the Funding and Tender Opportunities portal. The IHI JU 11th Call for proposals full topic text is also available.

The budget overview indicates that EUR 37,209,000 is allocated for this topic in 2025, with an indicative number of 1 grant.

This funding opportunity aims to significantly advance the field of beta-cell therapy for Type 1 Diabetes by addressing key challenges related to manufacturing, regulation, clinical development, and patient access. It encourages collaboration between researchers, industry, healthcare providers, and policymakers to develop standardized approaches, improve treatment outcomes, and integrate beta-cell therapies into standard diabetes care across Europe. The emphasis on AI-driven tools, real-world evidence, and cost-effectiveness models highlights the commitment to innovation and sustainability in healthcare solutions. The exclusion of legal entities from the UK and Canada is a notable restriction for potential applicants.

In simpler terms, this EU grant is all about finding better ways to treat Type 1 Diabetes using cell therapy. Type 1 Diabetes happens when the body's immune system destroys cells in the pancreas that make insulin. This grant wants researchers and companies to work together to make cell therapy a real cure. They want to make sure the therapy is safe, works well, is affordable, and can be used by everyone in Europe who needs it. The grant will fund projects that focus on making the cells, testing them, getting them approved by regulators, and even figuring out how to pay for them so everyone can get access. They also want to train doctors and create centers where people can go to get this new therapy. It's a big project that aims to make Europe a leader in this type of treatment and improve the lives of people with Type 1 Diabetes.

Eligible Applicant Types: The eligible applicant types are not explicitly stated in the provided text. However, based on the nature of Horizon Europe Research and Innovation Actions and the Innovative Health Initiative JU, eligible applicants are likely to include a mix of: research organizations (universities, research institutes), industry (including SMEs and large enterprises), healthcare providers, regulatory bodies, ICT companies, patient organizations, and policymakers. The call emphasizes the need for consortia with a strong industry contribution.

Funding Type: The funding type is a grant, specifically a HORIZON Action Grant Budget-Based [HORIZON-AG], as indicated by the "Type of MGA" information. The call is for HORIZON JU Research and Innovation Actions (HORIZON-JU-RIA).

Consortium Requirement: The opportunity requires a consortium. The text mentions "public consortia" and emphasizes the need for cross-sector collaboration, indicating that multiple applicants are required.

Beneficiary Scope (Geographic Eligibility): The primary geographic eligibility is for EU and associated countries, as this is a Horizon Europe call. However, the text notes that "A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects." Therefore, some third-country participation is possible, as detailed in the Horizon Europe Programme Guide.

Target Sector: The primary target sector is health, specifically focusing on: cell therapy, regenerative medicine, biotech/medtech, pharma/healthcare, artificial intelligence (AI), and ICT. The specific focus is on leveraging these sectors to advance beta-cell therapies for Type 1 Diabetes (T1D).

Mentioned Countries: The United Kingdom and Canada are explicitly mentioned as countries whose legal entities are not eligible for funding under topics HORIZON-JU-IHI-2025-11-04-two-stage and HORIZON-JU-IHI-2025-11-03-two-stage. The text also mentions "different European countries and healthcare systems" in the context of retrospective analyses, implying a focus on European participation.

Project Stage: The project stage is multifaceted, covering a range from development to validation and demonstration. The call aims to: accelerate the development of stem cell-based therapies, improve preclinical models, streamline clinical development, establish manufacturing processes, explore reimbursement models, and integrate cell therapy into diabetes care. This suggests projects should be at least in the development phase, with some aspects reaching validation and demonstration.

Funding Amount: The funding amounts vary by topic. For HORIZON-JU-IHI-2025-11-01-two-stage, the budget is EUR 20,202,000. For the other listed topics (HORIZON-JU-IHI-2025-11-04, -02, -03, -05), the total budget is EUR 37,209,000, with individual contributions around EUR 7,127,000 to EUR 12,351,000 per project. Therefore, the funding range is variable, but generally in the €7M to €12M range.

Application Type: The application type is a two-stage call, as indicated by "two-stage" in the topic descriptions and call information.

Nature of Support: The beneficiaries will receive money in the form of a grant to support their research and innovation activities.

Application Stages: The application process involves two stages: a short proposal in the first stage (20 pages limit) and a full proposal in the second stage (50 pages limit).

Success Rates: The success rates are not explicitly mentioned.

Co-funding Requirement: The text mentions that the "Annex to the budget and type of participants" is a compulsory annex to comply with IHI additional eligibility criteria (e.g. 45% industry contribution). This suggests that there is a co-funding requirement, specifically that 45% of the budget must come from industry contributions.

Summary: This is a Horizon Europe Innovative Health Initiative (IHI) JU call for proposals focusing on leveraging European expertise to accelerate cell therapy for Type 1 Diabetes (T1D). The call aims to support projects that address critical challenges in beta-cell replacement therapy, including renewable cell sources, manufacturing protocols, monitoring tools, and reimbursement models. The projects should contribute to the widespread adoption of beta-cell therapy, strengthen Europe's position in regenerative medicine, and align with EU health policies and initiatives. The call is structured as a two-stage process, requiring consortia with a strong industry contribution. Legal entities from the UK and Canada are ineligible for funding under certain topics. The funding is provided as a HORIZON Action Grant, with variable amounts depending on the specific topic, but generally in the €7M to €12M range. The call encourages synergies with other relevant initiatives and emphasizes the importance of ethical standards and data privacy. The overall goal is to improve healthcare quality, accessibility, and sustainability for individuals with T1D through advancements in cell-based therapies.