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Bio-printing of living cells for regenerative medicine
Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society
Estimated EU contribution per project
between € 6,000,000.00 and € 8,000,000.00
Link to the call
Link to the submission
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. Proposals should focus on bio-printing of living cells for regenerative medicine.
Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the "process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function". 3D-printing in general is considered an advanced manufacturing technique and 3D-printing of non-viable biomaterials to serve e.g. as scaffold for cell growth or as structure for medical devices is already broadly used.
However, bio-printing technology involving living cells is still in early stages of development, but has a huge potential for tissue engineering, drug testing and other biomedical applications. Tissue-specific functional 3D bio-printing is a new approach for transplantation applications in regenerative medicine, relying on the fabrication of tissues and organs with respect to the desired shape and function and their delivery and application in vivo. “In-situ bio-printing” known as printing cells and biomaterials directly onto or in a patient, or 4D bio-printing, which introduces a “time” variable that allows 3D printed materials to change shape or function when external stimulus is applied, are recent developments facing multiple additional challenges.
Despite some success of 3D bio-printing with thin tissue, thick tissue and complex organs remain a bottleneck because it is difficult to sufficiently mimic their metabolic needs, and the scientific knowledge about their intimate architecture and interplay with other tissues are not sufficiently elucidated. Next to these limitations are a lack of standardised manufacturing protocols and standardised bio-ink formulations with tuneable properties, unstable cellular behaviour, material biocompatibility and printability, etc. Taken together, 3D bio-printing is confronted with several challenges that currently hamper its large-scale deployment.
To overcome these challenges, researchers should work in multidisciplinary teams with engineers, biomedical scientists, cell biologists and medical doctors and proposals should address most of the following activities:
- Design the best bio-printing strategy for at least one type of tissue thanks to a better understanding of the interconnections of the different cell types inside the chosen tissue or organ
- Develop or improve existing equipment able to print bio-constructs with higher resolution in a shorter time using various biomaterials and different cell types
- Cover all steps of the bio-printing suite, including cell collection, cell differentiation and expansion, imaging, modelling, bio-ink formulation, actual bio-printing, nutrient supply, process monitoring and cell-construct delivery at target site
- Scale-up the chosen bio-printing technology to a GMP-conform manufacturing process
- Combine different bio-printing technologies in order to obtain fully functional synthetic constructs of complex tissues or organs.
Regulatory knowledge of the field is desired and should be documented through contacts with relevant national or international European regulatory authorities.
The chosen medical area (tissue, organ, condition) should be duly justified. Sex differences at the cellular level should be taken into consideration.
Preclinical stage and early clinical development are eligible. The involvement of SMEs is encouraged.
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
Proposals under this topic should aim for delivering results that are directed towards and contributing to several of the following expected Outcomes:
- Biomedical scientists will access entire bio-printing units for regenerating human tissue.
- Availability of larger-scale bio-printed tissues for biomedical research purposes to both industry and academia.
- Healthcare professionals acquire information on the safe and effective use of advanced therapies.
- Healthcare providers dispose of tools enabling them to treat conditions of unmet medical need.
- Individual patients will benefit from a personalised approach to their respective medical condition thanks to the bio-printed regenerative medicine solution.
Regions / countries for funding
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Azerbaijan (Azərbaycan), Belarus (Беларусь), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Island (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), New Zealand (Aotearoa), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
Education and training institution, International organization, 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)
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
- third 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.
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.
- Affiliated entities — 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 — 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 without legal personality — 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.
- EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
- 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.
other eligibility criteria
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.
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
All proposals 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.
Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.
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.
The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.