Reports of serious adverse events experienced by patients in Nebraska have been linked to use of an unapproved product containing exosomes, the FDA reports.
Within the last two months, fewer than five people became ill after receiving the unapproved product, according to Omaha.com. Details about the patients and the product used have not been released due to the investigation by Nebraska's Department of Health and Human Services. The product that is the subject of the investigation is no longer available in the state.
The Nebraska state health department issued an advisory focusing on the risks related to unapproved stem cell, placental and umbilical cord blood-derived products, including exosomes, a type of extracellular vesicles that are released from cells. The advisory reminds healthcare providers that use of unapproved cell-based products could result in growth of tumors and infections.
The FDA in its statement reiterated that there are "currently no FDA-approved exosome products."
"Certain clinics across the country… are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions," the statement reads.
The FDA urged patients considering treatment with exosome products to ask whether they have been reviewed by the FDA and potential risks.