Less than a year after the FDA warned old people against infusing the blood of young people, Stanford graduate Jesse Karmazin says his company, Ambrosia, is back in business despite the agency issuing a 'buyer beware,' according to OneZero.
Jesse Karmazin, the CEO and founder of Ambrosia, told OneZero in an interview that the company had resumed giving customers transfusions of plasma, the colorless liquid part of the blood, from young donors about a month ago. “Our patients really want the treatment,” he said. “Patients are receiving plasma transfusions from donors ages 16 to 25 again.” One-liter transfusions cost $8,000, and two-liter transfusions are $12,000. -OneZero
Karmazin, who isn't a licensed medical practitioner, stopped treating patients following the FDA announcement earlier this year and disabled his website.
Now, young blood is back on the market - you just have to get it "off-label," meaning a doctor can prescribe it for something other than its approved use.
Karmazin is a graduate of Stanford Medical School but does not have a license to practice medicine and does not do the transfusions himself. Instead, he contracts with doctors to do the procedures. When asked, he would not name any doctors he works with or other Ambrosia employees. He says the company does not obtain blood directly from young donors but gets it from licensed blood banks in the United States. -OneZero
"We’re a company interested in making you young again," he said at a 2017 conference. The company says that "experiments in mice called parabiosis provided the inspiration to deliver treatments with young plasma."
That said, while plasma can help blood to clot or to manage excessive bleeding during surgeries, experts say there is no basis for using it to slow or reverse aging-related diseases as Karmazin has claimed.
"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," read a February statement from FDA Commissioner Scott Gottlieb and Peter Marks, who leads the agency's biologics center.
"The reported uses of these products should not be assumed to be safe or effective," the said. "We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight."
"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 agency told OneZero "The FDA has not licensed or approved any plasma product obtained from young donors for any use."
As of last fall, the company had performed the procedure on about 150 people ranging in age from 35 to 92, while 81% of those people participated in the company's clinical trial. The trial gave patients one and a half liters of plasma from a donor between the ages of 16 and 25 and was conducted with David Wright, a physician who has his own intravenous blood therapy center in California.
Trial participants footed the bill for their own treatments - while the results of their clinical trials have not been publicly released.