[ad_1]
In the wake of a warning from the federal regulators, a controversial start-up that was charging US $ 8,000 to empty their veins with young blood allegedly stopped providing the procedure.
On Tuesday, the regulators of the Food and Drug Administration warned people against blood transfusions of young blood supposed to have anti-aging effects and other health benefits.
"There is no proven clinical benefit from infusion of plasma from young donors to cure, ameliorate, treat or prevent these conditions, and there are risks badociated with the use of any plasma product", said FDA Commissioner Scott Gottlieb and the director. Peter Marks, of the FDA's Center for Biologics Evaluation and Research, said in a joint statement.
The statement did not call any company by name.
Ambrosia is one of the only known companies to offer this procedure. Its founder, Jesse Karmazin, had previously told Business Insider that he charged $ 8,000 for 1 liter of young blood or $ 12,000 for 2 liters. He also stated that the transfusions were safe and reliable, despite little or no solid scientific evidence demonstrating its safety or benefits. Karmazin did not immediately return a message asking for comments on the recent FDA statement.
But since Tuesday afternoon, the Ambrosia website has been changed to read: "In accordance with the FDA announcement published on February 19, 2019, we have ceased treatments for patients."
One employee and one clinical trial with no published results
About three years ago, Karmazin launched Ambrosia and claimed that injecting younger patients with blood could help overcome aging by rejuvenating the body's organs.
Read more: A controversial start-up that charges $ 8,000 to fill the veins of a young blood patient opens a clinic in New York – but researchers whose work has inspired it warn that it's dangerous
Last month, Karmazin told Business Insider that the start-up was operational in five US cities. Ambrosia recently reorganized its website with a list of clinic locations and indicated that it was accepting payments for the procedure via PayPal.
In the fall, Karmazin – who is not a licensed physician, graduated from Stanford Medical School – told Business Insider that he was considering opening the first Ambrosia Clinic in New York. York from here the end of the year. That did not happen Instead, he said later, sites on which 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 to determine what happens when the veins of adults are filled with blood from younger people. Although the results of this study were not made public, Karmazin told Business Insider in September that they were "really positive".
There is no scientific evidence suggesting that the treatments could help anyone, however. Several experts who discussed the process with Business Insider raised red flags.
But because the FDA has approved blood transfusions for emergencies such as road accidents and other vital procedures, Ambrosia's approach has been pursued as a nonconforming treatment.
The idea of an anti-aging therapy based on blood seems to arouse considerable interest.
A week after its first Web site was launched in September, the company received about 100 requests for treatment information, said David Cavalier, Ambrosia's director of operations at the time, at Business Insider's autumn. This led to the creation of a waiting list, Cavalier said.
In January, Cavalier told Business Insider that he had left Ambrosia, leaving Karmazin as the sole public employee of the company.
Before leaving Ambrosia, Cavalier worked with Karmazin to identify potential New York hospital sites and hold discussions with potential investors, he said. In September, the company injected nearly 150 people between the ages of 35 and 92 into the blood, Cavalier said.
Of these 140 people, 81 were participating in their clinical trial on the government site ClinicalTrials.gov.
The two-day experiment consisted of giving patients 1.5 liters of plasma from a donor aged 16 to 25 years. She was performed with David Wright, a physician and owner of a private intravenous therapy center in Monterey, California. Before and after the infusions, participants' blood was badyzed for a handful of biomarkers, or measurable biological substances and processes meant to provide a snapshot of health and disease.
Trial participants paid $ 8,000, the same price as one of the procedures listed on the Ambrosia website.
"The trial was an experimental study," Cavalier said in September. "We have seen some interesting things and we are planning to publish this data, and we want to start opening clinics where treatment will be available."
Young and anti-aging blood: are there benefits?
Karmazin is right about the ability of blood transfusions to save lives. But the science of whether blood plasma injections in young people could help fight aging remains at best cloudy.
In early experiments on mice, Tony Wyss-Coray, director of the Alzheimer Research Center at Stanford University School of Medicine, founded a long-term, blood-plasma-based startup called Alkahest. cognitive benefits. The 150-year-old surgical technique that he used, parabiosis – whose name comes from the Greek words "para" or "beside" and "bio" or "life" – involves the exchange of the blood of two living organisms.
But the work of Alkahest is very different from that of Ambrosia. Their researchers aim to develop drugs for age-related diseases inspired by their work on plasma; they do not try to open a clinic.
Read more: The CEO of a start-up to tap the benefits of young blood shares his true plan to defeat aging
"The results were really impressive"
Karmazin told Business Insider in 2017 that he had had the idea to start his business as a Stanford medical student and intern at the National Institute of Aging where he had attended dozens of traditional blood transfusions performed safely.
"Some patients had young blood, some old blood, and I was able to do statistics about it, and the results are really impressive," Karmazin told Business Insider in 2017. "And I thought it was the kind of therapy that I would like to be available to me. "
Until now, no one knows if young blood transfusions can be reliably linked to lasting benefits.
Karmazin said that "many" of the approximately 150 people who had received the treatment had described benefits, including renewed attention, better memory and sleep, as well as improved muscle tone and appearance.
However, it is impossible to quantify these benefits as the results of the study have not been made public.
And on Tuesday, regulators urged caution.
"We strongly discourage consumers from taking this therapy outside of clinical trials under the control of an appropriate institutional review committee and under regulatory oversight," Gottlieb and Marks wrote in their letter on Tuesday.
Source link
