Over the past decade, our research has been deeply involved in European collaborative projects aimed at developing and translating cell-based therapies for bone repair. Working in close synergy with leading clinical and academic partners, we combine our expertise in mesenchymal stromal/stem cell (MSC) biology with complementary clinical know-how to address critical bone defects and fracture non-unions. From early autologous strategies to next-generation allogeneic approaches, this integrated effort enables the effective translation of research into clinical solutions. This expertise reflects the capacity of our entire group to work within a truly interdisciplinary framework and to advance research in regenerative medicine, with particular relevance to orthopedic and musculoskeletal applications. A major contribution of the team PI lies in the foundational work on MSC definition and standardization, including the internationally influential ISCT position statement on the minimal criteria for human MSCs, which helped establish key reference standards for the field.
WHAT WE DO?
REBORNE — Establishing the foundations of bone tissue engineering
Within the REBORNE project, a key contribution from our lab was the development of advanced approaches for the early functional characterization of MSC osteogenic potential, by in vitro and in vivo models, addressing donor-dependent variability that can affect clinical outcomes. By adopting a multiparametric strategy, we contributed to the identification of a robust osteogenic signature based on a defined set of genes, enabling the prediction of bone-forming capacity within clinically relevant timeframes.
This work supported the development of improved potency assays aligned with cGMP workflows and translational requirements. In parallel, we investigated cell handling and transportation under clinically relevant conditions, a critical but often underestimated aspect of advanced therapies. We demonstrated that MSCs expanded in GMP facilities can be transported under controlled conditions without compromising viability, proliferation, or osteogenic capacity, including their ability to generate bone in vivo when combined with biomaterials. These findings contributed to the validation of standardized logistics procedures, enabling the use of fresh cell-based products in multicentric clinical settings.
ORTHOUNION — Developing patient-specific regenerative therapies
Building on previous experience, our work focused on the functional evaluation and optimization of MSCs expanded under clinically relevant conditions and provided by GMP-compliant partner facilities.
A central aspect of our contribution was the implementation of reliable in vitro assays to assess cell potency and predict clinical performance, addressing variability among donors and improving the consistency of therapeutic outcomes. In this context, we contributed to the identification of the most promising gene markers as predictors of regenerative capacity, by correlating in vitro osteogenic differentiation profiles with clinical outcomes in patients treated with autologous cell-based therapies. This approach enabled a more robust selection of functionally competent cell populations for therapeutic use.
ORTHOALLOUNION — Moving towards off-the-shelf regenerative solutions
In the ongoing ORTHOALLOUNION project, we are contributing to the transition from autologous to allogeneic MSC-based therapies, aiming to develop scalable and readily available solutions for bone regeneration. Within this framework, the key objective of our work is the identification and selection of optimal donors based on previously defined gene signatures associated with regenerative potential. By applying these molecular criteria, we support the establishment of qualified cell sources for the generation of Master Cell Banks, ensuring consistency, potency, and reproducibility of the final therapeutic product intended for clinical use. By integrating our expertise with partners specialized in GMP manufacturing, clinical application, and regulatory processes, we contribute to the development of robust and standardized off-the-shelf therapies, ultimately expanding access to regenerative treatments for a broader patient population.