Cellular signaling vesicles
Exosomes are membrane-bound vesicles released by virtually every cell type. They carry a cargo of proteins, lipids, microRNAs, and other molecules from the parent cell. They are part of the normal cell-to-cell communication system and are increasingly studied as a delivery mechanism for therapeutic content.
Current FDA position
The FDA has issued multiple safety communications stating that exosome products are not FDA-approved and that several adverse events have been reported with unregulated products. Marketing of exosomes for therapeutic use is in active enforcement scope.