FDA issues public safety notification after exosome treatment sickens patients in Nebraska
Friday, January 17, 2020
In December, the Food and Drug Administration (FDA) issued a public safety notification regarding exosome products following multiple reports of serious adverse effects experienced by patients in Nebraska who received treatment with unapproved products derived from placentas.
Derived from endosomes and present in all body fluids, exosomes are a form of extracellular vesicle. Exosomes serve as carriers of different biomolecules, such as RNAs, proteins and lipids, from one cell to another to provide a means of intercellular communication and of transmission of these macromolecules.
Clinics administer exosome therapies through intravenous injection, inhalation, or injection into joints or soft tissue.
Within the past two months, several Nebraska patients developed severe infections after receiving unapproved cell-based therapies that included exosomes. Fewer than five people became seriously ill; some developed sepsis. All had received an exosome product derived from C-sectioned placentas.
Becker’s Hospital Review reports that the product is no longer available in Nebraska.
The FDA regulates stem cell therapies. The FDA has approved stem cell-based products that come from bone marrow or blood in transplant procedures, and only for limited use in patients with cancer or disorders of the blood or immune system. The FDA provides a list of approved stem cell-based products on its website. There are currently no FDA-approved exosome products.
Some clinics, including those that manufacture or market unlawful “stem cell” products, are now offering exosome products despite the lack of FDA approval. Many make unsubstantiated claims that the products can prevent, treat or cure certain conditions and treatments. Clinic workers may falsely claim that regulatory provisions for drugs and biological products do not cover the exosomes products when, in fact, the Public Health Service Act and the Federal Food Drug and Cosmetic Act subjects exosomes used as treatment to pre-market review and approval requirements.
Because they are offering exosome products outside of the regulatory process, the clinics are putting patients at risk for adverse effects. They may also be delaying care with approved and scientifically sound treatment options.
MedPage Today recently published a report on the growing trend of placenta donation programs offered by hospitals to women who are in labor or who are about to have a C-section. The report suggests that, while placental material does have legitimate applications in wound care and research, there is a large for-profit marketplace. This marketplace may have links to unapproved stem cell products.
While the patients that prompted the FDA’s public statement all resided in Nebraska, some clinics all over the country are offering exosome therapy for a number of conditions. A San Diego clinic offers exosome therapy as “the ultimate anti-aging hack,” for example, while a Delaware clinic peddles exosome therapy for the treatment of “Lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases.”
Care for patients with potential adverse effects with stem cell treatments
Healthcare providers and patients should be aware of the potential risks associated with unapproved stem cell treatments, and placental and umbilical cord blood derived products. The CDC and FDA describe these risks as:
- Failure of the cells to work as expected
- Administration site reaction
- Growth of tumors
- Potential for contamination of the product
- The ability of cells to move from placement sites or change into inappropriate cell types and multiply
Clinicians may wish to consider the possibility of procedure-related infection following the administration of stem cell and exosome therapies. Cultures and empirical treatment may be appropriate for patients with symptoms consistent with infection. The Nebraska Department of Health and Human Services says that bacteremias caused by E.coli, Enterobacter cloacae and polymicrobial agents have been reported in such patients.
The FDA is encouraging healthcare professionals and consumers to report adverse effects associated with the use of exosome products by filling out and submitting the MedWatch Online Voluntary Reporting Form online or via fax to 1-800-FDA-0178.
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