Cell-Derived Extracellular Vesicles for Immune Modulation: Preclinical and Clinical Perspectives

Small extracellular vesicles from many cell types have demonstrated potential promise as therapeutic strategies to modulate immune and inflammatory responses across a range of medical conditions. Most research to date remains preclinical in animal models of human disease, and the most common cell type for derivation of EVs is mesenchymal stromal cells. To understand the best approach to launching clinical studies and translating preclinical research to patients, a series of systematic reviews and meta-analyses of preclinical studies have been recently conducted and published. Across the range of animal models, the key issues identified were inadequate product characterization, variable dosing schedules and routes of administration, and inconsistent outcome measures. If these issues can be addressed, a more refined approach and optimized design of clinical trials will accelerate the field towards higher quality evidence that may facilitate more rapid approvals and more widespread clinical adoption.