Stem Cell-Derived Exosomes as New Horizon for Cell-Free Therapeutic Development: Current Status and Prospects

Abstract

Exosomes have come a long way since they were first described in 1981 by Trams et al. as small lipid bilayer-enclosed vesicles of endocytic origin. Their ability to alter cell bioactivity combined with their advancing popularity as disease biomarkers and therapeutic delivery systems has compelled major Government institutions and regulatory authorities to invest further in this ever-growing field of research. Being relatively new, exosome research is besieged by challenges including but not limited to inefficient separation methods and preservation techniques, difficulties in characterization, and lack of standardized protocols. However, as excitement and research on exosomes increase, their relevance and capacity to elicit a distinct biological response is reinforced. Therefore, it is pertinent to further explore their potential as cell-free therapeutics. This review focuses on current difficulties and subsequent strategies to refine existing methodologies for efficient clinical translation of exosomes in a streamlined and cost-effective manner. The chapter is briefly divided into subsections, each relevant for sequential therapeutic development such as their classification, isolation, scaling up, storage, characterizations, regulatory requirements, therapeutic developments, and perspectives. Apart from literature search, we have endeavored to bring in our own experience in this field including some recent clinical developments.