Fondazione Città della Speranza-Onlus awarded the project “SYNERGY – toward extracellular vesicle-based therapeutics for the treatment of bronchopulmonary dysplasia”. The project, started in 2019, aims to fill in the pre-clinical gaps required to allow the clinical application of extracellular vescicles (EVs) for the treatment of Bronchopulmonary dysplasia (BPD). In particular, the project, that lasts two years, intends to focus on the identification of the cellular target(s) of EVs, the identification of the pathways mediating the anti-inflammatory effect of EVs as well as the in vivo validation of the therapeutic procedure. Moreover, the metabolomic analysis for the selection of biomarkers predicting the development of BPD will be performed, to allow an appropriate selection of patients requiring specific intervention. Finally, the preparation of an Investigational Medicinal Product Dossier (IMPD) for submission to the regulatory Authorities is foreseen, paving the way for a first-in-man study. CVBF will provide regulatory support and will lead the preparation of the IMPD. The clinical translation of the project is supported by the production of clinical-grade EVs in a GMP facility.