Published by Springer and edited by Massimiliano Gnecchi – director of the Laboratory of Clinical and Experimental Cardiology, Policlinico San Matteo, Pavia (Italy) and researcher at the department of Molecular Medicine, Unit of Cardiology, University of Pavia – the volume aims to outline the current state of the art of MSC knowledge and emphasizes the need for clearly established and reproducible protocols to better define the identity, function, and use of MSC in cell therapy.

The Lugano cell factory’s contribution focuses on two aspects: the analytical methods designed to assess the safety (sterility, endotoxin, and mycoplasma assays) and identity/potency (cell count and viability, immunophenotype and clonogenic assay) of MSC as advanced therapy medicinal products (ATMP), and the validation strategies of the analytical methods for the control of mesenchymal stromal cells (MSC) for cell therapy clinical trials.

In presenting the second edition of the volume, Gnecchi points out that “because of their straightforward preparation and hypothetical immunologic privilege, MSC emerged as an extremely promising therapeutic agent for tissue regeneration and repair”, and nevertheless “at the same time, there are still unresolved issues associated with MSC related to their isolation, culture and expansion, phenotypic definition, multipotential differentiation, and mechanisms of action. The volume offers an important contribution to the knowledge of these topics.