Extracellular vesicles, which includes exosomes, are particles naturally released by cells which contain molecules and genetic material that direct cell behavior such as cell growth or differentiation. Dr Ambach was a part of the collaborative team effort of researchers, scientists and physicians from all over the world who published this manuscript on the clinical applications and therapeutic potential of EVs in the International Journal of Molecular Sciences on February 2026. These molecules and genetic material are at the forefront of research in diagnostics and therapeutics in the US, with active investigation into their use as biomarkers, drug delivery vehicles, and regenerative agents. While significant progress has been made, challenges related to standardization, scalability, targeting, and quality control must be addressed to fully realize their clinical potential. They are regulated as drugs and biological products and will need a Biologics License Application to lawfully market or an Investigational New Drug. There are currently no FDA-approved exosome products.
Here are the link to the papers:
Clinical Applications of Extracellular Vesicles: https://lnkd.in/gcptybhH
Therapeutic Potential of Extracellular Vesicles: https://lnkd.in/gMz5hzkK
