Mesenchymal stem cell-derived exosomes: A paradigm shift in clinical therapeutics.

Mesenchymal stromal/stem cell (MSC)-derived exosomes are nanoscale extracellular vesicles that have emerged as promising candidates for therapeutic and diagnostic applications because of their unique bioactive cargo, including proteins, lipids, and nucleic acids. These vesicles mitigate concerns of immunogenicity and tumorigenicity associated with MSC-based therapies and offer enhanced stability, higher scalability, and ease of modification. However, the use of MSC-derived exosomes in clinical practice is associated with challenges, including difficulties in isolation, characterization, and standardization. This review explores the biogenesis and structural properties of MSC-derived exosomes and discusses the molecular mechanisms underlying their therapeutic effects. It also discusses ongoing clinical trials on their applications in cancer, cardiovascular, neurological, and regenerative medicine. Preclinical and clinical data have demonstrated the potential of MSC-derived exosomes in enhancing tissue repair, reducing inflammation, and modulating immune responses. Despite these advancements, gaps in scalable production methods, regulatory guidelines, and therapeutic consistency must be addressed. Future innovations in bioengineering, manufacturing, and regulatory frameworks are essential to realize the full potential of MSC-derived exosomes in mainstream medicine.