In the wake of the FDA's caution, Ambrosia announced that it has "ceased patient treatments".
"Simply put, we're concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies", Dr. Scott Gottlieb, the FDA commissioner, and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. Amid the increasing popularity of this supposed anti-aging treatment, the FDA raised the red flag on the promotion and use of plasma from young donors for different health conditions because the treatment has not yet been scientifically proven effective.
The FDA officials, however, "strongly discouraged" consumers from pursuing the therapy outside clinical trials under appropriate institutional review and regulatory oversight.
Karmazin said last month that Ambrosia's clinical trial, which treated about 100 patients with one dose of plasma each, wrapped up about a year ago. More recent research has found that blood from young mice seems to rejuvenate the skeletal stem cells and livers of older mice, and even reverse heart decline in aging mice.
Plasma is the liquid component of blood, containing the proteins that help it to clot in the event of an injury. Food and Drug Administration says there is no clinical benefit to the procedure.
The agency hasn't approved plasma infusions for Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, post‐traumatic stress disorder and heart disease, common conditions patients look to have treated.
The FDA warned consumers and health care providers that treatments using plasma from young donors have not undergone testing normally required by the agency to ensure their benefit and safety.
Earlier in 2019, entrepreneur and Stanford University medical school graduate Jesse Karmazin, MD, opened four plasma transfusion clinics around the country to provide young blood to anyone over the age of 30 who wanted it - for the price of $8,000 to $10,000.
Plasma infusions from young donors can involve administering large amounts of plasma, which can be linked with infectious, allergic, respiratory and cardiovascular risks, according to the FDA. In addition to potential clotting, plasma is also not FDA approved in the treatment of memory loss and normal aging.
"Our concerns regarding treatments using plasma from young donors are heightened by the fact that there is no compelling clinical evidence on its efficacy, nor is there information on appropriate dosing for treatment of the conditions for which these products are being advertised".
The thinking behind young blood transfusions stems from a somewhat gruesome experiment conducted in the 1950s, when a Cornell researcher connected the circulatory systems of a young and old mouse, according to New Scientist's Helen Thomson.