NorCal Startup Shuts Down After FDA Warning On 'Young Blood' Anti-Aging Treatments
(CBS SF) -- A Northern California startup touting anti-aging treatments has ceased operations after the U.S. Food and Drug Administration warned against using so-called "young blood" plasma infusions as a way to ward off the effects of aging and to treat other medical conditions.
Monterey-based Ambrosia Health had offered intravenous infusions of plasma - which contains proteins that help clot blood - from donors aged 16 to 25 to treat a variety of conditions including heart disease, dementia and post-traumatic stress disorder - as well as halting and reversing the normal aging process.
In Greek mythology, ambrosia is food or drink of the gods which confers longevity or immortality to those who consume it.
Without naming Ambrosia or any other company, the FDA said on Tuesday it had "significant public health concerns" about establishments in several states offering young blood plasma treatments.
"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," FDA Commissioner Scott Gottlieb and Peter Marks, director of the FDA's Center for Biologics and Evaluation and Research, said in a statement.
Founded in 2016 by Stanford Medical School graduate Jesse Karmazin, Ambrosia offered a liter of the blood for $8,000 or two liters for $12,000. Patients were able to book appointments in five cities and pay for the service online.
"There are certainly tech folks from Silicon Valley signing up, there are pretty much people from most states, people from overseas people from Europe and Australia have come to be treated," Karmazin told KPIX 5 in 2017.
Hours after the FDA's warning, Ambrosia announced on its website Tuesday it had "ceased patient treatments" to be in compliance with the FDA announcement.
Ambrosia did not immediately respond to a request by KPIX 5 for comment.
"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," Gottlieb said.
An investigation by Huffington Post in December showed that despite a participant-funded study that Karmazin claimed was a success, he never showed any proof that the transfusions helped patients. The only patient who spoke publicly about the transfusions died of cardiac arrest at age 65, Huffington Post reported.
"You can easily imagine a situation where somebody who's vulnerable, and not wealthy, and not healthy, and may be desperate ... would potentially feel like they have no option but to spend this money," University of California, San Francisco physician Phuoc Le told Huffington Post. "They could literally spend their life savings on an unproven treatment."
Another biotech firm, San Carlos-based Alkahest welcomed the FDA announcement, noting that its clinical candidates for plasma treatments were being developed with oversight from the FDA.
In a statement, Alkahest co-founder and CEO Karoly Nikolich said, "It is critical for the good of public health that regulatory oversight and high scientific standards remain pillars of therapeutic development. At Alkahest, we are developing FDA-reviewed therapeutic modalities, including selected and proprietary plasma fractions that are created from pooled plasma by a well-established protein fractionation process."
