Exosomes: Regulation for neurodegenerative therapy requires a specialized approach

Those aged 65 years and older are at high risk for neurodegenerative diseases such as Alzheimer's, Parkinson's, and dementia. These diseases are costly to the healthcare system, and the growing number of patients requires improved therapies. One approach that has shown therapeutic potential in preclinical research is exosome therapy. Despite the existence of rigorous clinical testing and manufacturing models, the U.S.'s current regulatory structure lacks the specificity to fully address exosome safety concerns. Notably, exosomes contain unique and heterogeneous content that can jeopardize patient safety if imprecisely regulated. Furthermore, safety and regulatory standards vary internationally. This paper introduces two potential options to standardize exosome treatment: creating a new regulatory classification system for exosomes in the U.S., and establishing a robust international reporting and regulatory system.