The FDA on Feb. 19 issued a safety alert about the growing trend of taking plasma from a young person and infusing it into an older person to ward off aging, Bloomberg reports.
"There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat or prevent these conditions, and there are risks associated with the use of any plasma product," FDA officials said in the statement, referencing claims that this type of therapy can prevent aging and memory loss, as well as treat dementia, Parkinson's disease, multiple sclerosis and Alzheimer's disease.
Three things to know:
1. FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, head of the agency's biologics center, issued the alert to highlight that plasma infusion for these types of aging-related conditions should "not be assumed to be safe or effective," and carry risks, such as allergic reactions and infectious disease transmission.
"We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight," they wrote. "We're concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies."
2. Plasma infusion — which is an FDA-approved procedure in the trauma setting and for patients whose blood doesn't coagulate — as a method to prevent or treat aging-related conditions has fascinated many technology entrepreneurs in Silicon Valley, including billionaire Peter Thiel. However, the FDA officials emphasized that these use cases have not undergone rigorous testing required by the agency.
3. One startup, Ambrosia, sold blood plasma from donors between the ages of 16 and 25 for $8,000 per liter, citing "experiments in mice called parabiosis provided the inspiration to deliver treatments with young plasma." In compliance with the FDA's advisory, the startup updated its website Feb. 19 to say that it had "ceased patient treatments."