Abstract
Extracellular vesicles (EVs), including exosomes and microvesicles, derived from mesenchymal stem/stromal cells (MSCs) exert similar effects as their parental cells, and are of interest for various therapeutic applications. EVs can act through uptake by the target cells followed by release of their cargo inside the cytoplasm, or through interaction of membrane-bound ligands with receptors expressed on target cells to stimulate downstream intracellular pathways. EV-based therapeutics may be directly used as substitutes of intact cells or after modification for targeted drug delivery. However, for the development of EV-based therapeutics, several production, isolation, and characterization requirements have to be met and the quality of the final product has to be tested before its clinical implementation. In this review, we discuss the challenges associated with the development of EV-based therapeutics and the regulatory specifications for their successful clinical translation.
Highlights
Extracellular vesicles (EVs), including exosomes and microvesicles, are nanoscale vesicles that are released by all cell types and act as signaling/communication agents between adjacent or distant cells
We summarize the recent developments in EV production for pharmaceutical manufacturing, and discuss the regulatory issues associated with their clinical application
The heterogeneity of mesenchymal stromal/stem cells (MSCs) used for EV production (BM, adipose tissue, other tissues; non-manipulated or immortalized) and of the obtained EVs makes difficult to select the EV drug with the highest therapeutic efficacy
Summary
Extracellular vesicles (EVs), including exosomes and microvesicles, are nanoscale vesicles that are released by all cell types and act as signaling/communication agents between adjacent or distant cells. EVs derived from mesenchymal stromal/stem cells (MSCs) display similar functions as their parental cells and show therapeutic efficacy in many non-clinical models (Keshtkar et al, 2018). MSC-derived EVs (MSC-EVs) exert their functions through the transfer of their cargo (i.e., proteins, lipids, and nucleic acids such as mRNA, micro-RNAs, long non-coding RNAs, DNA, and metabolites) (Busatto et al, 2019; Qiu et al, 2019). They can be used as therapeutic tools either in naïve form, as substitutes of intact cells, or after modification for targeted drug delivery. We summarize the recent developments in EV production for pharmaceutical manufacturing, and discuss the regulatory issues associated with their clinical application
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