Controversial startup ceases treatments
Young Blood Benefits?
What are the benefits of an anti-aging therapy based on blood transfusions from young people to older people? Some experts say “none,” while others warn of the dangers of the procedure.
Ambrosia, a controversial startup company was charging $8,000 to fill people’s veins with young blood. The company stated that it has stopped operations after a warning from federal regulators, according to an article by Erin Brodwin in Business Insider, which reported that the startup said it was up and running in five cities.
Several researchers, including those whose original science inspired the procedure, have said that such a procedure is dangerous. On Tuesday, regulators with the Food and Drug Administration (FDA) warned people against getting transfusions of young blood that claim to provide anti-aging and other health benefits.
The FDA commissioner, Scott Gottlieb, and the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, said in a joint statement, “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.” The statement did not name any specific companies.
Ambrosia is one of the only companies known to offer the procedure. Jesse Karmazin, its founder, said that he was charging $8,000 for 1 liter of young blood or $12,000 for 2 liters. He added that the transfusions were safe and reliable, in spite of little to no hard scientific evidence revealing either its safety or its efficacy. Ambrosia’s website had been changed to read, “In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments.”
About 3 years ago, Karmazin launched Ambrosia and claimed that it provided anti-aging benefits. Recently, he said that the startup was up and running in five US cities. The company revamped its website with a list of clinic locations and said it was accepting payments for the procedure via PayPal.
In the fall, Karmazin, who is not a licensed medical practitioner but graduated from Stanford Medical School, said that he planned to open the first Ambrosia clinic in New York City by the end of the year. While that did not happen, Karmazin said that the sites where customers can get the procedure include Los Angeles; San Francisco; Tampa, Florida; Omaha, Nebraska; and Houston, Texas.
In 2017, Ambrosia enrolled people in a clinical trial with the objective of finding out what happens when the veins of adults are filled with blood from younger people. Although the results of that study have not been made public, Karmazin said that they were “really positive.”
There is no scientific evidence to support the use of the treatments to help anyone, but because the FDA has approved blood transfusions for emergencies like car crashes and other life-saving procedures, Ambrosia’s approach was able to continue as an off-label treatment. There seems to be significant interest in the idea of an anti-aging therapy based on blood.
A week after establishing its first website in September, the company received roughly 100 inquiries about how to get the treatment, David Cavalier, Ambrosia’s chief operating officer at the time, said. He added that there was a waiting list. By January, Cavalier had left Ambrosia, making Karmazin as the company’s only public employee.
Before leaving Ambrosia, Cavalier worked with Karmazin to find potential clinic locations in New York and arrange talks with potential investors. By September, the company had infused close to 150 people, ranging in age from 35 to 92, with the blood of younger donors. Of those 140 people, 81 were listed as participating in its clinical trial on the government website ClinicalTrials.gov.
As Business Insider reported, “The two-day experiment involved giving patients 1.5 liters of plasma from a donor between the ages of 16 and 25. It was conducted with David Wright, a physician who owns a private intravenous-therapy center in Monterey, California. Before and after the infusions, participants’ blood was tested for a handful of biomarkers, or measurable biological substances and processes thought to provide a snapshot of health and disease. Trial participants paid $8,000, the same price as one of the procedures listed on Ambrosia’s website.”
Cavalier said in September, “The trial was an investigational study. We saw some interesting things, and we do plan to publish that data. And we want to begin to open clinics where the treatment will be made available.”
While Karmazin is right about the capacity of blood transfusions to save lives, the science on whether infusions of young blood plasma could help fight aging remains unclear. Karmazin said that “many” of the 150 people who had gotten the treatment described benefits such as renewed focus, better memory and sleep and improved appearance and muscle tone. Still, the study’s findings have not been made public, and regulators have urged caution.