- A startup called Ambrosia Medical that charges $8,000 to fill your veins with the blood of young people plans to launch its first clinic in New York City at the end of this year.
- Researchers who study blood transfusions called the procedure “dangerous” and said the idea behind it is based on “incorrect interpretations” of their work.
- Founded by Stanford graduate Jesse Karmazin, the company recently completed the first clinical trial designed to assess the benefits of young blood transfusions.Those results have not been published.
Does young blood hold the keys to a long and healthy life? Startup founder and and Stanford Medical graduate Jesse Karmazin believes it might, so he launched a startup called Ambrosia Medical that fills older people’s veins with fresh blood from young donors.
But researchers who study the procedure say it poses major risks for patients, including an elevated risk of developing several serious conditions later in life, such as graft-versus-host disease, which can occur when transfused blood cells attack the patient’s own cells, and transfusion-associated lung injury.
Irina and Michael Conboy, two University of California at Berkeley researchers who’ve published research on young blood transfusions in mice, called Ambrosia’s plans “dangerous.”
“They quite likely could inflict bodily harm,” Irina Conboy told Business Insider.
The Conboys’ concern stems from an awareness of what happens in the body when it receives foreign blood from a donor.
“It is well known in the medical community — and this is also the reason we don’t do transfusions frequently — that in 50% of patients there are very bad side effects. You are being infused with somebody else’s blood and it doesn’t match,” Conboy said. “That unleashes a strong immune reaction.”
Karmazin told Business Insider that the Conboys’ statements “are not supported by data or clinical experience.”
“Millions of plasma transfusions are performed safely in the US each year and the FDA monitors the safety of the blood supply and transfusions closely. We agree with the Conboys that exposure to young plasma has potential beneficial effects. Further research in this field at Stanford and Harvard, amongst other institutions, indicates that ‘blood dilution’ is not responsible for the observed effects, so it is not clear what the basis for that statement is.”
The first clinical trial of its kind
Getty Images/Joern Pollex In 2017, Ambrosia enrolled people in the first US clinical trial designed to find out what happens when the veins of adults are filled with blood from the young.
While the results of that study have not yet been made public, Karmazin told Business Insider the results were “really positive.”
Because blood transfusions are already approved by the Food and Drug Administration, Ambrosia’s approach has the green-light to continue as an off-label treatment. There appears to be significant interest: since putting up its website last week, the company has received roughly 100 inquiries about how to get the treatment, David Cavalier, Ambrosia’s chief operating officer, told Business Insider. That led to the creation of the company’s first waiting list, Cavalier said.
“So many people were reaching out to us that we wanted to make a simple way for them to be added to the list,” Cavalier said.
With that in mind, Cavalier and Karmazin are currently scouting a number of potential clinic locations in New York City and organizing talks with potential investors. They hope to open the facility by the end of this year.
“New York would be the flagship location,” Karmazin said.
Blood tranfusions are already approved by federal regulators, so Ambrosia does not need to demonstrate that its treatment carries significant benefits before offering it to customers.
So far, the company has already infused close to 150 patients ranging in age from 35 to 92 with the blood of young donors, Cavalier said. Of those, 81 were participants in their clinical trial.
The trial, which involved giving patients 1.5 liters of plasma from a donor between the ages of 16 and 25 over two days, was conducted with physician David Wright, 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 that are thought to provide a snapshot of health and disease.
People in the trial paid $8,000 to participate. The company hasn’t settled on a commercial pricetag for the procedure, Karmazin said.
Young blood and anti-aging: ‘There’s no reality here’
Conboy’s research was one of a handful of studies that initially inspired Karmazin to pursue young blood transfusions for anti-aging benefits.
But she told Business Insider that Karmazin’s work was based on an “incorrect interpretation.”
“Not only is it incorrect, it’s dangerous,” Conboy said.
Conboy followed up that work with a more recent study in 2016 to see what would happen if she merely exchanged the rodents’ blood without connecting their bodies in any way. She found that while the muscle tissue in the older mice appeared to benefit slightly from the younger blood, they still couldn’t say for sure that these modest benefits were coming from the young blood itself. After all, the experiment had also fundamentally changed the older mouse blood by diluting it.
“Something about the old blood seemed to be having a negative effect, yes, but young blood was not capable of rejuvenation,” Conboy said.
Michael Conboy said part of the problem is simply the fact that there’s too much old blood for the young blood to have a substantial effect on its own.
“Is there really something in the young blood that would override all the negative effects from the old blood?” Conboy said. “Until someone repeats that I’m not sure that I believe it. Even scientists with the best of intentions can observe something that’s a fluke.”
Meanwhile, the Conboys said there are substantial risks with giving older people the young blood of donors. Those include a heightened immune response which is triggered with increasing magnitude every time the procedure is completed.
In 2005, Conboy pioneered a study using parabiosis, a 150-year-old surgical technique that connects the veins of two living animals, to see whether the blood from a younger mouse could have benefits on an older mouse.
And while she did observe some benefits as a result of the procedure, she pointed out to Business Insider that the animals weren’t simply swapping blood — the older rodent was also reaping the benefits of the younger one’s more vibrant internal organs and circulatory system too. Conboy believes that — not the young blood itself — is likely what accounted for the positive effects she saw.
“When old and young mice are sutured together they share organs too — including their kidneys and all the important filtering organs,” Conboy told Business Insider. “Imagine you had a new liver. You’d probably see benefits too.”
A 2012 study published in the journal Transfusion outlines the risks of blood transfusions and includes these risks, as does published work from the National Center for Biotechnology Information.
“Every time you do it you’re magnifying your immune response,” Michael Conboy said. “Reputable physicians who do this for life-threatening conditions know this risk.”
SEE ALSO:A controversial startup that charges $8,000 to fill your veins with young blood is opening its first clinic
Maand: maart 2019
The bloody tale of Ambrosia, the anti-aging startup founded by a Stanford graduate
Source: https://www.mercurynews.com/2019/02/25/the-bloody-tale-of-ambrosia-the-startup-that-wants-to-slow-aging/By Bloomberg |
By Olivia Carville | Bloomberg
In 2016, a tiny startup announced an experiment that seemed equal parts medieval sorcery and science fiction: It would inject older people with the blood plasma of young donors in a bid to slow aging.
For three years, Ambrosia Chief Executive Officer Jesse Karmazin charged patients $8,000 to infuse one liter of plasma as part of an unorthodox, crowd-funded clinical trial. Karmazin promised extraordinary results” going so far as to proclaim in media interviews that his treatment “comes pretty close” to immortality.
Last week, the U.S. Food and Drug Administration poured cold water on his improbable dream. The regulator, echoing individual medical experts, issued a warning saying the treatment’s benefits are unproven and that the practice could be harmful.
“We’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies,” the FDA said, without naming any companies or individuals. Ambrosia” named after the mythical food that conferred immortality on Greek gods” announced soon after that it was ceasing all treatments.
Karmazin hasn’t responded to repeated requests for comment since the FDA announcement. Last month, as he planned to open infusion clinics in New York and elsewhere, he explained to Bloomberg the provenance of his startup and his hopes for success. But now that the federal government has gotten involved, his dream may instead seem like a cautionary tale” one in which America’s perpetual obsessions of youth and technology joined together for one fantastical, and ultimately doomed, moment.
“It just occurred to me, like ‘wow, transfusions are the same thing for humans.’”
Testing whether young plasma can breathe new life into older patients is fairly unremarkable in the medical world. Scientists have been running controlled anti-aging and rejuvenation tests for a century” but on rodents, not people.
For 150 years, scientists have been stitching together old mice and young mice to allow their blood to pump through each other’s veins. The practice, called parabiosis, often resulted in lab rats contracting infections and dying, and in the 1970s it was largely discarded. But advances over the past 15 years have revived the technique. Nowadays, parabiosis pairs are sniffing around cages in university laboratories across America.
Some studies purport to show the blood of young mice having rejuvenated the aging organs of older mice, making them stronger, smarter and healthier. It has even made their fur shinier, other researchers have claimed.
Dr. Gurpreet Baht of Duke University’s Molecular Physiology Institute said he is working with four parabiosis pairs he personally sewed together. He said his research found that fresh blood circulation made the older mice’s blood cells “really act young again,” even healing bone fractures faster than normal. But he was dismissive when it came to claims related to humans.
“We’re still at the level of mouse models,” Baht said. “I don’t think the information is out there for humans. Humans are more complicated.”In 2014, Dr. Saul Villeda of the University of California, San Francisco, led a study in which the blood plasma of three-month old mice was injected into 18-month-old mice (a mouse’s lifespan is about 2 years). Villeda said the older mice performed significantly better after the infusion. But experts regularly emphasize that, in medical testing, mice and humans are decidedly not the same.
Karmazin had just graduated from Stanford University Medical School around the time Villeda’s study was published. Originally from Palm Beach Gardens, Florida, Karmazin said he had long been interested in the “often overlooked” field of aging.
While observing a blood transfusion in an emergency room, Karmazin said he had his “eureka moment.”
“I was thinking about the [mice] research and it just occurred to me, like ‘wow, transfusions are the same thing for humans,’” he said. Karmazin said he dropped out half-way through his residency and founded Ambrosia. On the company’s website, he wrote: “Experiments in mice called parabiosis provided the inspiration to deliver treatments with young plasma.”
Karmazin, 34, wasn’t able to practice medicine because he hadn’t completed his residency. Instead, he said he partnered with physicians in California and Florida who agreed to perform plasma infusions at their own clinics. Karmazin said he provided them with plasma from donors under the age of 25, purchased from blood banks.
In his interview with Bloomberg, Karmazin said he had treated 150 patients. Their blood was tested in the days before the treatment and one month after it, allowing a comparison of biomarkers. He said he found precancerous cells and amyloids, which indicate Alzheimer’s, had fallen by up to 20 percent post-treatment. He provided no evidence to support the claim.
Karmazin said plasma recipients with Alzheimer’s were “doing their finances again” and others with “severe heart disease” were able to run up stairs. He didn’t provide any evidence for those claims, either. Karmazin said he planned to publish the results once they were peer-reviewed, but didn’t say where, or who was doing the reviewing.
One 62-year-old from southern California said in a telephone interview arranged by Karmazin that he had been receiving infusions for more than a year. He is only the second person to speak publicly about his treatment by Ambrosia. The man, a mathematician who requested anonymity to protect his medical privacy, said a motorcycle accident in 2011 had left him partially paralyzed. After the infusions, he said he could sleep through the night again and generally felt better.
“It just occurred to me, like ‘wow, transfusions are the same thing for humans.’”
Leading researchers in the regenerative medicine field strenuously reject Ambrosia’s premise.
“Those [mice] studies don’t provide a scientific basis for what Ambrosia is offering,” said Dr. Amy Wagers, co-chair ofthe Harvard Department of Stem Cell and Regenerative Biology. Parabiosis conjoins an entire organ system, whereas plasma infusion is just one element, she said.
“The research we are doing can be sensationalized,” said Villeda, of the University of California. “In order to avoid hoax studies we need appropriate clinical trials.”
Such trials are completed in controlled environments and governed in part by federal guidelines. Companies must meet a set of standards before making any health claims. However, Karmazin didn’t need the FDA to approve his trial because he was offering a pre-approved procedure” a basic blood infusion” as an off-label treatment. Still, he sought approval from the Institute of Regenerative and Cellular Medicine’s Institutional Review Board (IRB), an independent group which determines whether a study on human subjects is ethical.
Dr. Barbara Krutchkoff, co-chair of the institute’s IRB and a consultant in biomedical studies, said in an interview that she signed off on Karamzin’s study because it was a medically approved procedure and “nothing out of the ordinary.”
“People have done weird things over the years to think they could become younger and this was not the weirdest,” she said, adding that she’s faced her own critics for the decision. “They’ve said ‘who do you think you are allowing him to do this?’”
“Some people spend $8,000 to go to the Super Bowl,” Krutchkoff said. “If you want to spend $8,000 to get a young person’s blood transfusion and it feels good, then why the hell not?” Overall, she said, the treatment is “no more dangerous than walking across the street.”
The possibility of human longevity has been a popular hobby in Silicon Valley. Billionaire tech entrepreneurs such as Peter Thiel, Y Combinator president Sam Altman and Tesla CEO Elon Musk have been pouring money into bio-engineering startups. The tech industry’s desire to cheat death was even lampooned in a 2017 episode of HBO’s “Silicon Valley.” It showcased human-to-human parabiosis, with a young “blood boy” directly transfusing his blood into a wealthy, aging recipient.
Despite the obvious appetite for holy grail startups, when Karmazin came knocking, venture capital firms didn’t answer. “It’s been somewhat difficult to raise money,” he said. “I’ve talked with a number of potential investors, but we haven’t raised money at this point.” He blamed it on people being “squeamish” about blood.
As 2019 began, Karmazin said he was excited for the future. He described plans to open a clinic in New York because it’s an “affluent place where people can afford it,” and possibly Texas and Ohio soon after.
Then the FDA weighed in.
In their warning, FDA Commissioner Scott Gottlieb and Peter Marks, head of the agency’s biologics center, wrote they had become aware of people “charging thousands of dollars for infusions that are unproven and not guided by evidence from adequate and well-controlled trials.”
“We will consider taking regulatory and enforcement actions against companies that abuse the trust of patients and endanger their health with uncontrolled manufacturing conditions or by promoting so-called ‘treatments’ that haven’t been proven safeor effective for any use,” the regulator said. Hours later, the Ambrosia website was updated to say: “In compliance with the FDA announcement issued Feb. 19, 2019, we have ceased patient treatments.”
“It just occurred to me, like ‘wow, transfusions are the same thing for humans.’”
Karmazin hasn’t made any public statements since. Krutchkoff said Karmazin told her that he was going to “put everything on hold.”
This comes as a relief to Dr. Irina Conboy, a rejuvenation researcher at the University of California, Berkeley. She said she’s had concerns about Ambrosia for years. Plasma infusion is only reserved for life-threatening situations, Conboy said, because it can trigger serious side effects, such as allergic reactions, circulatory overload, lung injury and infectious disease transmission.
In 2016, she published a paper on mice-to-mice blood transfusions. She said Karmazin called her office, leaving a voicemailmessage to say how much he enjoyed her research and that it fell into line with the treatment he was providing at Ambrosia. Inthe message, she said he asked if they could work together. Conboy said she never returned his call.
For Conboy, the most frustrating part of the Ambrosia saga is that it tarnishes the area of regenerative medicine, where she said scientists are on the brink of ground-breaking discoveries that could truly help ailing elderly patients.
“Do not inject yourself with blood,” she said. “Wait a couple of years until we have a safe and rational treatment based on science.”
©2019 Bloomberg L.P.
The Roots Of Evil 