Earlier this year, Ambrosia completed the first clinical trial in the U.S. to test the possible health benefits of transfusions of young donor blood, by giving 81 patients a single large dose of plasma from donors age 16 to 25. The study used self-reported, subjective metrics like energy levels, sleep quality and athletic performance, as well as blood tests before and one month after treatment, to measure 113 biomarkers for things like kidney function and inflammation. While they have not yet published the results, Ambrosia founder Jesse Karmazin told Rolling Stone that they were promising. “The data looks really great,” he says. “It makes people younger, I think it’s a huge breakthrough.”
Some experts, though, are not convinced. Neuroscientist Tony Wyss-Coray of Stanford University, who led a 2014 young plasma study in mice, told Science magazine, “There’s just no clinical evidence [that the treatment will be beneficial], and you’re basically abusing people’s trust and the public excitement around this.” In an email to Rolling Stone, Dr. Wyss-Coray called Ambrosia “immoral” and compared them to climate change deniers. He elaborated that the methodology of Ambrosia’s study was not up to industry standards because patients acted as their own controls by receiving plasma in one round and a placebo in another.
“It needs to hold up in double-blinded placebo-controlled studies where neither the doctor nor the patient know if they are being treated with the drug or not,” he says. “If a drug or treatment are not tested in this way, they should not be advertised as such.”
“It is really very simple,” he continues. “The immoral aspect of selling treatments and using false claims is that desperate, poor people may spend their savings, that they are given false hope, and that they may get harmed.”
Ambrosia has not yet set a market price for the treatment, but volunteers paid $8,000 each to participate in the clinical trial. Bioethicists have called for an end to so-called “pay to play” clinical trials, arguing that allowing patients to pay to participate “compromises the overall integrity of clinical research,” but Karmazin has maintained that the practice is not unusual and noted that the study passed an ethics review. Karmazin estimates that commercial treatment costs will likely be similar to the costs during the trial, or slightly higher.
“The goal is for the treatment to be available to most people, but healthcare is expensive in the U.S.,” he says.
Since putting up their website last week, Ambrosia has received roughly 100 inquiries from eager patients looking to sign up for treatment, David Cavalier, Ambrosia’s chief operating officer, told Business Insider. To accommodate demand, the company set up a waiting list on their homepage. “We’re getting inquiries every day,” says Karmazin, who’s unsure exactly how many people are on the waiting list currently.
Since blood transfusion is already an approved and highly common medical procedure used to treat trauma victims and those with various illnesses, Ambrosia’s clinical trial didn’t have to go through the usual rounds to prove the safety of a new treatment, they just need to get approval for an off-label usage.
The precedence for young blood transfusions comes studies showing that older mice’s health improved after they received blood from younger mice. In the initial studies, researchers surgically joined two mice together so their blood mixed and circulated through both bodies, in a process called parabiosis, and the older mice showed improved tissue regeneration, muscle tone, and liver function—while the younger mice aged more rapidly. A 2014 study found similar health benefits from the much simpler procedure of transfusing older mice with plasma from younger mice. Karmazin founded Ambrosia in 2016 to determine whether humans might see similar benefits in transfusions of young plasma, and he’s confident that their trial shows it can.
Since the results have not yet been peer reviewed, we’ll have to wait and see whether Ambrosia has truly found a fountain of youth, or just a bloody snake oil.