Objectives

CLinical translation of Extracellular VEsicle-based Renal Regeneration uitklapper, klik om te openen

The formulation of standardized and uniform release criteria is critical in order to test EV-based therapeutics in clinical trials and develop them further into a clinical product (including GMP-compliant manufacturing, isolation and purification). Hence, there is an urgent need for a new generation of scientsts which will establish uniform guidelines and standardized procedures. Moreover, in order to comply with the current regulatory frameworks, insight in the mode of action and efficacy of EVs is needed. Currently, it is for example not known whether the mode of action of EVs depends on the content of the vesicles, the vesicle membranes or a combination of both. These issues will need to be addressed in order to advance the clinical development of EVs as therapeutic drugs.

The CLEVER project brings together a strong, international consortium of leading academic and non-academic partners to address hurdles that limit the clinical translation, commercialization and broad uptake of promising novel EV-based therapeutics by training of the next-generation of translational scientists, performing top research and establishing a sustainable network of key stakeholders to ensure fast and efficient knowledge transfer.