�Թϲ�����

Federal health regulators on Tuesday warned consumers against controversial “young blood” treatments — plasma infusions from young donors marketed for conditions such as Parkinson’s, Alzheimer’s, multiple sclerosis and post-traumatic stress disorder. “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,” Scott Gottlieb, commissioner of the Food and Drug Administration, and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said in a statement. (McGinley, 2/19)

Plasma is the liquid portion of blood. Because it contains proteins and can be used to treat bleeding and clotting abnormalities, it has potential benefits in trauma care and other settings. Nevertheless, said Drs. Gottlieb and Marks in a statement, “We’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies.” The two FDA officials said the agency had received reports of “bad actors” charging thousands of dollars for infusions. (Burton, 2/19)

"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 Commissioner Dr. Scott Gottlieb wrote in a statement Tuesday. "The reported uses of these products should not be assumed to be safe or effective," he added, noting that the FDA "strongly" discourages consumers from using this therapy "outside of clinical trials under appropriate institutional review board and regulatory oversight." (Scutti, 2/19)

The FDA referenced reports of young people’s blood plasma being touted as a treatment for conditions ranging from “normal aging and memory loss to serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder.” (Sullivan, 2/19)

The idea of infusing young blood to fight aging has attracted technology entrepreneurs like billionaire Peter Thiel and was lampooned in a 2017 episode of the HBO show “Silicon Valley.” Thiel’s reported interest was sparked by a company called Ambrosia, which has locations in five states across the U.S. and sells one liter of blood plasma from donors between the ages of 16 and 25 for $8,000, according to its website. (Edney, 2/19)

A startup called Ambrosia claims that it is now offering young-blood transfusions — at a cost of $8,000 for 1 liter of young blood, or $12,000 for 2 liters — in Los Angeles, San Francisco, Houston, Tampa, Fla., and Omaha, Neb., Business Insider reported last month. The entrepreneur behind that company, Jesse Karmazin, has yet to report the results of a clinical trial he ran testing the procedure, which involves an off-label use of an approved product. On Tuesday, however, following the release of the FDA statement, a notice on Ambrosia’s site said it would no longer offer the transfusions. (Robbins, 2/19)

The startup company selling young donors’ blood in Houston has apparently shut down in response to a Food and Drug Administration statement Tuesday that such infusions provide no clinical benefit. In the statement, the FDA said it is alerting consumers and health-care providers to its concerns about “the promotion and use of young donor blood” purporting to treat the effects of conditions such as Parkinson’s, Alzheimer’s and heart disease. The statement said it recently became aware of the business model in some states. (Ackerman, 2/19)