Company shuts down young blood therapy
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.
“We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight,” wrote Dr. Scott Gottlieb, FDA commissioner, and Dr. Peter Marks, director of the agency’s Center for Biologics Evaluation. “Treatments using plasma from young donors have not gone through the rigorous testing the FDA normally requires in order to confirm the therapeutic benefit of a product and ensure its safety.”
Ambrosia Health, the Monterey, Calif.-based company that last month launched in Houston, subsequently posted on its website that it has “ceased patient treatments” in compliance with the FDA announcement.
There was no other message
on the website, and its founder did not respond to a request for comment.
Ambrosia was charging $8,000 for intravenous infusions of 1 liter of plasma provided by donors between 16 and 25 years of age and $12,000 for 2 liters. It touted that the therapy could rejuvenate older people’s blood and perhaps treat certain conditions.
The company was thought to be the first forprofit company marketing blood from young donors as therapy, the latest of a number of unproven interventions being marketed to consumers before research has demonstrated the treatment is safe and effective. Stem cell therapy is the classic example.
Ambrosia was inspired by academic research that found injecting old mice with the plasma portion of blood from young mice seemed to improve the elderly rodents' memory and ability to learn. The only follow-up, clinical trial has showed a modest benefit in a small number of Alzheimer's patients.
Gottlieb and Marks, who did not specify any company by name, wrote, "Simply put, we’re concerned some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies. Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful.”
The statement added that there are reports “of bad actors charging thousands of dollars for infusions” and “dosing of these infusions (that) can involve administration of large volumes of plasma that can be associated with significant risks including infectious, allergic, respiratory and cardiovascular risks, among others."
Leigh Turner, a University of Minnesota bioethicist, said the statement was “typically slow by the FDA but better late than never.”
“This was a clear, forceful response to misleading claims being made about plasma, a flare fired off about how the FDA is going to interpret regulations,” said Turner. “You never know whether some risk takers will still be willing to roll the dice, but they’d have to do so knowing the FDA considers such activity out of compliance.”
Turner said Ambrosia likely got the message that “the jig was up, that the FDA is paying attention.” He said he wouldn’t be surprised if there was a behind-thescenes agreement in which Ambrosia agreed to cease operations to to head off an FDA warning letter.
Ambrosia has been treating patients since 2016. From its initial sites in Florida and California in 2016, it expanded to Houston, Phoenix and Omaha, Neb., in early 2019, founder Jesse Karmazin told the Chronicle in mid January.
Karmazin would not then reveal the location of the Houston clinic, citing patient privacy.
He said then that Ambrosia has infused young people’s blood in about 150 patients overall, including 100 in a clinical trial it completed a year ago with participants who paid full price for the procedure.