Description
Exo-Wound aimed to develop, standardize and formulate a biological medicine based on exosomes (small extracellular vesicles) derived from umbilical cord blood cells, for the treatment of chronic wounds. During the execution of the project, several goals necessary for product development were achieved, such as: a) development of a standardized process for exosome purification, which allows for large-scale manufacturing and facilitates transfer into a GMP production unit; b) definition of the tests and quality control criteria to be used during exosome characterization, in the context of production for clinical use; c) development of a hydrogel formulation capable of delivering exosomes to the wound, without loss of stability and bioactivity; d) evaluation of the toxicological profile of exosomes in animal models; e) demonstration of the therapeutic efficacy of the final product, Exo‑Wound (exosomes embedded in the hydrogel formulation), in advanced animal wound models. Having achieved these goals enabled the continued development of Exo-Wound, which is predicted to follow into a phase of clinical tests, in preparation for its future commercialization.