Work packages

WP1
Clinical needs definition, GMP and regulatory conformity

The LUMINATE project embarks on a journey to redefine osteochondral (OC) tissue regeneration, ensuring that patients suffering from knee cartilage and bone injuries receive groundbreaking, personalized treatment. Through its innovative in situ bioprinting technology, LUMINATE develops a minimally invasive, one-stage solution that could eliminate the need for traditional joint replacement surgeries.

This WP also focuses on scaling up production, developing standardized protocols for large-scale bioresin manufacturing and ensuring that clinical-grade materials are ready for use in hospitals. By the end of the project, LUMINATE will have:

✔️ A fully compliant dossier for regulatory approval.

✔️ GMP-certified protocols for manufacturing bioresins and bioprinting hardware.

✔️ A roadmap for the first clinical trials to bring this technology to orthopedic patients.

WP2
Optimizationg photoresins for Osteochondral Regeneration

At the heart of LUMINATE’s regenerative approach is the creation of bioengineered photoresins designed specifically for cartilage and bone repair. These biomaterials serve as the foundation for the bioprinted constructs that will integrate seamlessly into damaged joints. Researchers work tirelessly to develop resins that are biocompatible, mechanically strong, and capable of mimicking the native tissue environment.

For cartilage regeneration, the project develops a gelatin-hyaluronic acid-based bioresin that incorporates patient-derived chondrocytes and allogenic mesenchymal stromal cells (hMSCs) to promote rapid tissue healing. On the other hand, a bone-specific resin infused with nano-hydroxyapatite is designed to stimulate osseointegration, allowing bone tissue to regrow naturally. These materials must not only support cellular activity but also respond to precise light-based crosslinking processes that will occur within the body.

Through continuous formulation testing, rheological analysis, and in vitro validation, LUMINATE ensures that these bioresins are safe, effective, and scalable for clinical applications. By the project’s completion, these resins will be ready for regulatory approval and manufacturing under GMP guidelines, ensuring a seamless transition from research to real-world application.

WP3
Cell processing and cell-based tissue formation

At the core of WP3 lies the development of robust, clinically relevant strategies to engineer cartilage tissue using a combination of patient-derived chondrocytes and allogenic mesenchymal stem cells (hMSCs). Researchers are refining rapid isolation and mixing protocols to ensure high cell viability and functionality, while optimizing bioresins that support cell migration, matrix formation, and tissue integration.

These efforts extend to building a functional osteochondral unit with distinct cartilage and calcified layers, mimicking the natural joint environment. By incorporating sex-based analyses and advanced imaging tools like OCT, the project ensures that each bioprinted construct meets rigorous quality standards and is tailored for personalized, regenerative therapies.

WP4
In Silico Modeling & Optimization

Bringing bioprinting technology to life requires precise digital modeling and computational analysis. WP4 harnesses the power of artificial intelligence and advanced simulations to refine every aspect of LUMINATE’s bioprinting process.

Using AI-driven models, researchers simulate tissue behavior, optimize material deposition patterns, and predict the long-term biomechanical performance of printed constructs. This ensures that every bioprinted scaffold matches the complexity and durability of natural tissue. Furthermore, AI algorithms analyze patient-specific lesion data, automatically adjusting printing parameters to create truly personalized treatments.

By integrating machine learning and real-time imaging, LUMINATE ensures that each surgery is precise, predictable, and optimized for success. These in silico models drastically reduce development time and the need for costly experimental trials, accelerating the pathway toward clinical implementation.

WP5
Preclinical Testing & Validation

As LUMINATE moves closer to human applications, rigorous preclinical testing becomes the final proving groundfor its bioprinting suite. WP5 is dedicated to evaluating the safety, efficacy, and biological integration of EndoFLight’s bioprinted constructs.

Initial tests focus on in vitro cell cultures and tissue explants, ensuring that the bioresins support cellular activity and matrix formation. Moving forward, the project scales up to animal models, where small-animal studies (mice) help determine early-stage biological responses, while large-animal models (sheep) allow full-scale evaluation of joint repair in a human-relevant setting.

Through a combination of histological analysis, biomechanical testing, and imaging techniques such as MRI and micro-CT, researchers assess:

  • The structural fidelity of bioprinted cartilage and bone.
  • The rate of cellular integration and tissue maturation.
  • The mechanical resilience of the regenerated tissue under load-bearing conditions.

These findings will be essential in demonstrating that LUMINATE’s technology is safe, effective, and ready for the next step—clinical trials.

WP6
Preclinical Testing & Validation

As LUMINATE moves closer to human applications, rigorous preclinical testing becomes the final proving groundfor its bioprinting suite. WP5 is dedicated to evaluating the safety, efficacy, and biological integration of EndoFLight’s bioprinted constructs.

Initial tests focus on in vitro cell cultures and tissue explants, ensuring that the bioresins support cellular activity and matrix formation. Moving forward, the project scales up to animal models, where small-animal studies (mice) help determine early-stage biological responses, while large-animal models (sheep) allow full-scale evaluation of joint repair in a human-relevant setting.

Through a combination of histological analysis, biomechanical testing, and imaging techniques such as MRI and micro-CT, researchers assess:

  • The structural fidelity of bioprinted cartilage and bone.
  • The rate of cellular integration and tissue maturation.
  • The mechanical resilience of the regenerated tissue under load-bearing conditions.

These findings will be essential in demonstrating that LUMINATE’s technology is safe, effective, and ready for the next step—clinical trials.

WP7
Surgeon Training & Clinical Implementation

Even the most advanced medical technology requires skilled hands to bring it to life. WP7 ensures that surgeons across Europe are prepared to integrate LUMINATE’s bioprinting approach into their practice.

Through a combination of VR/AR training simulations, hands-on workshops, and real-world surgical demonstrations, orthopedic specialists learn:

✔️ How to use EndoFLight effectively in arthroscopic procedures.
✔️ How to optimize bioprinting parameters for different types of osteochondral injuries.
✔️ How to integrate AI-driven guidance into surgical workflows.

By establishing best practices and clinical guidelines, LUMINATE guarantees that hospitals can seamlessly adopt this technology, paving the way for widespread implementation.

WP8
Exploitation and IPR Management

WP8 focuses on the project’s impact beyond its duration, benefiting both industry and healthcare. This will include actions for managing intellectual property, to ensure long-term use and commercialisation of results, and a business plan comprising, among others:

  • the solutions on offer and the customer value proposition
  • an assessment of the macro-environment/innovation ecosystem and of relevant public policies
  • target markets, competition, success factors, risk assessment and mitigation plans
  • respective barriers for market uptake

Exploitation efforts will be supplemented by a spin-off company to lead the commercialisation process and ensure widespread application of LUMINATE’s technological solutions.

WP9
Project Communication, Dissemination, and Outreach

As LUMINATE advances its mission to bring regenerative therapies closer to clinical reality, WP9 ensures that the project’s voice resonates far beyond the laboratory environment.

This work package orchestrates a comprehensive communication and dissemination strategy, with professional branding and an active online presence, the project’s achievements are shared widely across scientific, clinical, and public audiences.

Through scientific publications, industry events, and targeted outreach, the consortium shares its progress while building a community of researchers, clinicians, and innovators. Dedicated efforts also focus on shaping future policy, with workshops and recommendations aimed at guiding the responsible development of advanced therapies. Together, these activities ensure that LUMINATE’s impact extends beyond scientific progress, reaching into broader societal benefit.

WP10
Project coordination and management

LUMINATE’s scientific breakthroughs is supported by a robust operational framework, ensuring that the project runs smoothly from start to finish. Led by UNIPI, the consortium operates through a lean management model, supported by regular meetings, continuous monitoring of progress and collaboration. To maintain the highest standards, WP10 also oversees quality assurance, risk management, and data stewardship—ensuring that all deliverables are reviewed, refined, and aligned with FAIR data principles.

Together, these efforts provide the foundation for LUMINATE’s success, enabling the science to thrive within a well-managed and transparent environment.