February 20, 2019
It was big news in early 2019 that a business named Ambrosia Health had apparently uncovered the answer to anti-aging: injecting the blood of younger people into older people to combat the signs of aging.
There was some science behind the concept as the method pulls from parabiosis, a technique that dates back to the late-1800s. According to the National Institutes of Health, parabiosis, the procedure of joining two animals so that they share each other's blood circulation, has revitalized the concept of blood as an accepted drug.
That said, Ambrosia’s website stated as of Tuesday that the company has “ceased patient treatments,” likely due to an official statement from FDA commissioner Scott Gottlieb and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.
Gottlieb’s statement asserts that there is no proof that plasma from young donors can be used as a treatment for dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease or post-traumatic stress disorder, as claimed.
The plasma infusions can also be dangerous, the agency added, because they are associated with infectious, allergic, respiratory and cardiovascular risks.
“We’re alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing that the FDA normally requires in order to confirm the therapeutic benefit of a product and to ensure its safety,” the statement reads.
The federal agency noted that several businesses offer infusions of plasma costing thousands of dollars per infusion for a variety of conditions. Such companies can often avoid FDA drug approval processes because plasma transfusions are a well-established procedure. Ambrosia, for example, had been charging $8,000 for one liter of blood and $12,000 for two as part of a “clinical trial.” The blood was donated by 16- to 25-year-olds to consumers ages 35 and older, NBC News reports.
“We’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies,” Gottlieb and Marks said in their statement. “Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them, and are potentially harmful.”
Per CNN, the FDA is concerned not only that the plasma itself may be harmful but that the "unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments that may be available to them."