Leveraging Europe's Expertise to accelerate Cell Therapy for Type 1 Diabetes
Innovative Health Initiative Joint Undertaking Research and Innovation Actions
Funding Amount
Amount not specified
Deadline
09/10/2025
Eligible Organization Types
Non-profit, Private Business, Research Institution, Public Institution
Trusted by
What is the Leveraging Europe's Expertise to accelerate Cell Therapy for Type 1 Diabetes Call?
Grant Description
Calls for public consortia to develop and standardize analytical methods, immune-modulating strategies, manufacturing processes, preclinical and clinical development tools, AI-driven predictive models, patient-centred endpoints, reimbursement models, and integration networks to accelerate the adoption, efficacy, and accessibility of beta-cell therapies for type 1 diabetes and strengthen Europe’s leadership in regenerative medicine.
Required Results for Successful Funding
Expected Outcomes
Proposed actions must deliver all of the following outcomes:
• A standardised framework for impurity thresholds and manufacturing best practices, enabling regulatory alignment and scalable production of safe, effective beta-cell therapies.
• Validated immune-modulating strategies, advanced preclinical models and biomarkers to assess engraftment success, metabolic function and immune responses.
• Established scalable, cost-effective manufacturing processes and quality-control criteria for regulatory approval and reimbursement support.
• Improved preclinical models and clearly defined clinical criteria for diverse patient demographics to ensure safety, efficacy and accessibility.
• AI-driven predictive models and real-time monitoring technologies to personalise treatment plans, optimise immunosuppression and reduce therapy failure.
• Adoption of patient-centred clinical endpoints that reflect quality of life and disease burden in Type 1 Diabetes.
• Cost-effectiveness assessments, pilot reimbursement programmes and policy recommendations to underpin a sustainable reimbursement framework.
• Training programmes for endocrinologists, diabetologists and transplant surgeons, and the development of clinical pathways in collaboration with professional societies.
• Fully operational European innovation hubs fostering collaboration among academia, industry, regulators, patient organisations and policymakers to harmonise practices and accelerate therapy adoption.
• Tangible benefits for people living with diabetes, including improved treatment options, long-term health outcomes and overall quality of life.
• A standardised framework for impurity thresholds and manufacturing best practices, enabling regulatory alignment and scalable production of safe, effective beta-cell therapies.
• Validated immune-modulating strategies, advanced preclinical models and biomarkers to assess engraftment success, metabolic function and immune responses.
• Established scalable, cost-effective manufacturing processes and quality-control criteria for regulatory approval and reimbursement support.
• Improved preclinical models and clearly defined clinical criteria for diverse patient demographics to ensure safety, efficacy and accessibility.
• AI-driven predictive models and real-time monitoring technologies to personalise treatment plans, optimise immunosuppression and reduce therapy failure.
• Adoption of patient-centred clinical endpoints that reflect quality of life and disease burden in Type 1 Diabetes.
• Cost-effectiveness assessments, pilot reimbursement programmes and policy recommendations to underpin a sustainable reimbursement framework.
• Training programmes for endocrinologists, diabetologists and transplant surgeons, and the development of clinical pathways in collaboration with professional societies.
• Fully operational European innovation hubs fostering collaboration among academia, industry, regulators, patient organisations and policymakers to harmonise practices and accelerate therapy adoption.
• Tangible benefits for people living with diabetes, including improved treatment options, long-term health outcomes and overall quality of life.
Funded areas
Scope Requirements
Proposals must:
1. Address the eight key objectives: analytical standards, immune tolerance, manufacturing/QC, preclinical/clinical development, advanced monitoring/AI tools, patient-centred endpoints, reimbursement models, and integration into care networks.
2. Tackle the core T1D challenges of renewable cell sources, islet preparation, harmonised regulatory pathways, monitoring, reimbursement and professional training, as highlighted in the Draghi Report.
3. Engage early with regulators (EMA Innovation Task Force, national competent authorities) and HTA bodies to tailor evidence generation and regulatory strategy.
4. Develop a sustainability plan for maintenance, update and validation of results beyond project end.
5. Ensure transparent, open dissemination of models, tools and data with interoperability, provenance and traceability.
6. Comply with ethical standards and data privacy frameworks for use of personal health data and biobanks.
7. Explore synergies with complementary initiatives (NHPIG, Vanguard, Islet-project, JOIN4ATMP, EPITR) to leverage existing assets.
1. Address the eight key objectives: analytical standards, immune tolerance, manufacturing/QC, preclinical/clinical development, advanced monitoring/AI tools, patient-centred endpoints, reimbursement models, and integration into care networks.
2. Tackle the core T1D challenges of renewable cell sources, islet preparation, harmonised regulatory pathways, monitoring, reimbursement and professional training, as highlighted in the Draghi Report.
3. Engage early with regulators (EMA Innovation Task Force, national competent authorities) and HTA bodies to tailor evidence generation and regulatory strategy.
4. Develop a sustainability plan for maintenance, update and validation of results beyond project end.
5. Ensure transparent, open dissemination of models, tools and data with interoperability, provenance and traceability.
6. Comply with ethical standards and data privacy frameworks for use of personal health data and biobanks.
7. Explore synergies with complementary initiatives (NHPIG, Vanguard, Islet-project, JOIN4ATMP, EPITR) to leverage existing assets.
Additional Conditions for Applicants
Special Conditions
- Two-stage submission: Stage 1 short proposals (20 pages), Stage 2 full proposals (50 pages).
• Model Grant Agreement: HORIZON Action Grant Budget-Based [HORIZON-AG].
• Eligible participants per Horizon Europe Annex B; legal entities in the UK and Canada are ineligible for funding under this topic.
• Specific conditions on Availability, Accessibility and Affordability (3A) do not apply.
• JU retains right to object to transfer or exclusive licensing of results.
• Beneficiaries must accept that direct improvements to their background assets will be transferred back to the contributing party; this must be addressed in the consortium agreement.
• Consortia must meet IHI-specific eligibility criteria (e.g., 45% industry contribution) and submit compulsory annexes: Type of Participants, Budget & In-Kind Contributions, Declaration of In-Kind Contribution Commitment, Essential Information for Clinical Studies, Ethics Annex (if applicable).
• Proposals must align with general Horizon Europe and IHI JU call conditions, evaluation rules, budget rules (Annexes A–G of the Work Programme), and use provided templates.
• Model Grant Agreement: HORIZON Action Grant Budget-Based [HORIZON-AG].
• Eligible participants per Horizon Europe Annex B; legal entities in the UK and Canada are ineligible for funding under this topic.
• Specific conditions on Availability, Accessibility and Affordability (3A) do not apply.
• JU retains right to object to transfer or exclusive licensing of results.
• Beneficiaries must accept that direct improvements to their background assets will be transferred back to the contributing party; this must be addressed in the consortium agreement.
• Consortia must meet IHI-specific eligibility criteria (e.g., 45% industry contribution) and submit compulsory annexes: Type of Participants, Budget & In-Kind Contributions, Declaration of In-Kind Contribution Commitment, Essential Information for Clinical Studies, Ethics Annex (if applicable).
• Proposals must align with general Horizon Europe and IHI JU call conditions, evaluation rules, budget rules (Annexes A–G of the Work Programme), and use provided templates.
Important dates
Open from: 17/06/2025
Deadline:09/10/2025
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