Exosome therapy
Exosomes are nanosized extracellular vesicles that are secreted by cells and act as messengers for cell-to-cell communications. They are usually derived from stem cells and injected or administered by IV. They are also used topically in skincare treatments.
Claims: Exosomes are touted to address cellular damage, musculoskeletal disorders, nerve injury, muscle tears, pain and inflammation and improve the body’s immune response. Some claim a potential to treat cancer.
Risks: Researchers believe they hold promise, but much about them is unknown, including risks. There have been reports of serious complications, including cancer relapse and severe inflammatory responses, after patients received exosome therapy without medical oversight. The Nebraska Department of Health issued warnings in 2019 after several patients there became seriously ill after treatment with unapproved cell-based therapies with exosomes. Some physicians have noted that IV infusions of exosomes may vary in quality and should be matched to the right patient.
Regulations: In 2019 and again in 2020, the FDA warned the public about so-called regenerative medicine products such as exosomes. The FDA considers exosomes to be biologic drugs that require full clinical trials and FDA approval before marketing. There presently are no FDA-approved exosomes for human use.
Red flag: Clinics saying that exosome treatments are FDA registered; that does not mean that they are FDA approved.
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