- A controversial blood-transfusion startup called Ambrosia was offering to fill a person’s veins with the blood of young people for $US8,000, despite little to no hard evidence that the procedure had any benefits.
- On the heels of a warning from federal regulators on Tuesday, Ambrosia said on its website that it had stopped giving the procedure.
- Last month, Business Insider reported exclusively that the startup claimed to be up and running in 5 cities.
- As Business Insider previously reported, several researchers – including those whose original science inspired the procedure – have warned that such a procedure is dangerous.
On the heels of a warning from federal regulators, a controversial startup that offered to fill a person’s veins with young blood for $US8,000 said it had stopped providing the procedure.
On Tuesday, regulators with the Food and Drug Administration warned people against getting transfusions of young blood that purport to provide anti-ageing and other health benefits.
“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 FDA commissioner, Scott Gottlieb, and the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, said in a joint statement.
The statement didn’t call out any companies by name.
One of the only companies known to offer the procedure, however, is called Ambrosia. Its founder, Jesse Karmazin, previously told Business Insider that he was charging $US8,000 for 1 litre of young blood or $US12,000 for 2 litres. He also said the transfusions were safe and reliable, despite little to no hard scientific evidence demonstrating either its safety or its benefits. Karmazin didn’t immediately return a message seeking comment on the recent FDA statement.
But as of Tuesday afternoon, Ambrosia’s website had been changed to read: “In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments.”
A single employee and a clinical trial with no published results
Roughly three years ago, Karmazin launched Ambrosia and claimed that infusing older patients with younger blood could help conquer ageing by rejuvenating the body’s organs.
Karmazin told Business Insider last month that the startup was up and running in five US cities. Ambrosia recently 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 – told Business Insider he planned to open the first Ambrosia clinic in New York City by the end of the year. That didn’t happen. Instead, he later said, 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 designed to find out what happens when the veins of adults are filled with blood from younger people. While the results of that study have not been made public, Karmazin told Business Insider in September that they were “really positive.”
There’s no scientific evidence to suggest that the treatments could help anyone, however. Several experts who have spoken with Business Insider about the process have raised red flags.
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 appears to be significant interest in the idea of an anti-ageing therapy based on blood.
A week after putting up 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, told Business Insider in the fall. That led to the creation of a waiting list, Cavalier said.
In January, Cavalier told Business Insider he’d left Ambrosia, leaving Karmazin as the company’s only public employee.
Before departing from Ambrosia, Cavalier worked with Karmazin to scout several potential clinic locations in New York and organise talks with potential investors, he said. As of September, the company had infused close to 150 people, ranging in age from 35 to 92, with the blood of younger donors, Cavalier said.
Of those 140 people, 81 were listed as participating in its clinical trial on the government website ClinicalTrials.gov.
The two-day experiment involved giving patients 1.5 litres 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 $US8,000, the same price as one of the procedures listed on Ambrosia’s website.
“The trial was an investigational study,” Cavalier said in September. “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.”
Young blood and anti-ageing: Are there any benefits?
Karmazin is right about the capacity of blood transfusions to save lives. But the science on whether infusions of young blood plasma could help fight ageing remains murky at best.
In early experiments in mice, Tony Wyss-Coray, a director of the Alzheimer’s research center at Stanford University Medical School who founded a longevity startup focused on blood plasma called Alkahest, found that swapping old blood plasma for young blood plasma appeared to provide some limited cognitive benefits. The 150-year-old surgical technique he used, parabiosis – whose name comes from the Greek words “para,” or “beside,” and “bio,” or “life” – involves exchanging the blood of two living organisms.
But Alkahest’s work is very different from Ambrosia’s. Their researchers aim to develop drugs for age-related diseases that are inspired by their work with plasma; they are not looking to open a clinic.
‘The results looked really awesome’
Karmazin told Business Insider in 2017 that he got the idea for his company as a medical student at Stanford and an intern at the National Institute on Ageing, where he watched dozens of traditional blood transfusions performed safely.
“Some patients got young blood, and others got older blood, and I was able to do some statistics on it, and the results looked really awesome,” Karmazin told Business Insider in 2017. “And I thought this is the kind of therapy that I’d want to be available to me.”
So far, no one knows whether young blood transfusions can be reliably linked to lasting benefits, however.
Karmazin said that “many” of the roughly 150 people who had received the treatment described benefits including renewed focus, better memory and sleep, and improved appearance and muscle tone.
Yet it’s impossible to quantify these benefits as the study’s findings have not been made public.
And on Tuesday, regulators urged caution.
“We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight,” Gottlieb and Marks wrote in their letter on Tuesday.