ExpectedOutcome:
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”. To that end, 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.
Scope:
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.
