Feb. 20, 2019 — Ambrosia Health has shut down its clinics offering transfusions of young blood plasma after the FDA issued a statement saying the science was unproven.
“In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments,” says a statement on Ambrosia Health’s website.
Earlier in 2019, entrepreneur and Stanford University medical school graduate Jesse Karmazin, MD, opened four plasma transfusion clinics around the country to provide young blood to anyone over the age of 30 who wanted it — for the price of $8,000 to $10,000.
Karmazin could not be reached for comment about the FDA statement. Before the FDA action, however, Karmazin, 34, told WebMD he decided to open his clinics based on the results of a clinical trial he ran with 100 patients that tested the same concept. Although the results from that trial aren’t published, Karmazin says they back his claims. He also points to similar research on mice.
Karmazin opened clinics in Omaha, NE, Los Angeles, San Francisco, and Tampa, FL.
The plasma — the fluid left after blood cells are removed — came from 16- to 25-year-olds and was tested for multiple pathogens including the Zika virus and HIV, Karmazin says.
While the FDA did not name Ambrosia in its release, it cautioned consumers that there is “no proven clinical benefit” to the transfusions. Although blood transfusions are considered safe for people who need them to survive, side effects can include hives, lung injury, and deadly infections.
“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. Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful,” the FDA statement says.
Other experts interviewed before the FDA’s action agreed that it was too early and the science is too thin to market plasma transfusions as an anti-aging remedy.
Steven Joffe, MD, MPH, a pediatric oncologist and bioethicist at the University of Pennsylvania, calls the transfusions “dangerous” and says people could be wasting their money.
Joffe says Karmazin’s study wasn’t a blinded, controlled study that compared the treatment to a placebo — something that’s considered the gold standard for clinical trials. Without that, Joffe says, “the data that comes out is going to be useless.”
“To do it the right way, you recruit volunteers and not charge them, maybe you even reimburse them,” Joffe says. “There are ways to get high-quality results. It’s by doing vigorous, blinded, placebo-controlled trials that are not funded on the backs of participants.”
Mark Allen, MD, co-founder and CEO of Elevian, one of a handful of companies currently conducting plasma transfusion clinical trials, says that at best, they are “a weak therapeutic.”
“There’s way too much snake oil,” he says. “As a scientific community, we don’t want to over-hype things and make sure what we’re doing is based on science. There is something real here and let’s not do something that ruins the credibility of the science.”
Karmazin has said the plasma transfusions are not marketed for aging, but admitted it’s difficult to pitch the benefits without talking about aging.
“We don’t market it that way,” he says, “but most people understand that’s what it is.”
What the Research Shows
The idea that plasma transfusions might be a potential “fountain of youth” came from studies in mice using a technique called parabiosis. Although it was first tried hundreds of years ago, researchers have shown increased interest in recent years. In parabiosis, researchers surgically join old and young mice together so they share a circulatory system. That gives the older mice a constant supply of younger blood. Studies have shown parabiosis to boost the heart health, muscle growth, and brain function in the older mice, among other rejuvenating effects.
But these results have not always been repeated in other studies. And Allen says you can’t equate results from stitching two animals together with a human receiving a single plasma transfusion. And the good proteins that someone would receive in a single transfusion are minute.
“The real misperception in peoples’ minds is that these results apply to transfusions here and there,” he says.
He also cited quality control issues with the donated plasma. “If a young person is diseased, you can’t check every single way that they could be diseased,” Allen says. “We’re giving a broad cocktail and some elements are good and some might be bad.”
The medical community has learned from the past that transfusions can be safe, but not without risk, he says.
“We saw with HIV and hepatitis when we did transfusions, we didn’t know to check for those pathogens,” he says. “What do we not know now?”
Anti-Aging Proteins in Your Blood
Allen says he believes that a more promising path is to focus on which proteins in plasma have anti-aging properties.
“It’s interesting and there are things to be learned, but the effects would be so much stronger if we can figure out the proteins and turn this in to a medication,” Allen says. “Right now, we have a lot of research to do to pursue discoveries of new molecules that are more convenient and more affordable.”
One protein scientists are excited about is GDF11, which plays an important role in embryonic development and aging. Elevian’s founders and others have demonstrated that its activity decreases with age in mice and humans, and that lower levels of the combination of it and another protein predicts increased risk of disease and death in humans, Allen says.
Several labs have demonstrated benefits from daily injections of extra doses of GDF11 in animal models of heart disease, Alzheimer’s disease, stroke, diabetes, kidney failure, COPD, age-related muscle dysfunction, and several forms of cancer and inflammatory diseases, Allen says.
Allen says Elevian is developing new drugs to potentially treat a number of age-related diseases by targeting GDF11 and expects to begin human testing in 2 to 3 years.
Allen said there is still much unknown about the protein, with debate among the scientific community about exactly what it can and can’t do.
Another company looking into blood proteins is Alkahest. CEO Karoly Nikolich, PhD, says it is studying 5,000 to 6,000 proteins, sifting through which ones cause tissue to age and which ones support cell survival.
“We discovered that when you age, out of all the proteins, only about 1,000 change and 4,000 don’t,” Nikolich says. “It’s fascinating detective work.”
Alkahest co-founder Tony Wyss-Coray, PhD, who worked on parabiosis trials in mice at Stanford University and is a neuroscientist there, said a human trial on Alzheimer’s disease the company conducted met expectations. They plan to continue more studies.
“There was no indication that people were just cured,” he says. “We have encouraging results but the study was just too small.”
Wyss-Coray says it’s like finding a needle in a haystack.
“Plasma is made up of thousands of protein factors and molecules, and it’s difficult to find which one is the key ingredient,” he says. “There’s more than one that is beneficial, and there’s more than one that is detrimental.”
He says he is encouraged but also doesn’t want to make promises.
“It concerns me, in general, if people take a drug that is not tested in a rigorous way, especially if they pay for it,” he says. “The medical community has agreed over decades of research of how to find if a drug will work or not, and if you bypass that, it gives people false hope.”
WebMD Article Reviewed by Neha Pathak, MD
Sources
Jesse Karmazin, MD, CEO, Ambrosia Health.
Karoly Nikolich, PhD, CEO, Alkahest.
Mark Allen, co-founder/CEO, Elevian.
Steven Joffe, MD, MPH, pediatric oncologist and bioethicist, University of Pennsylvania.
Tony Wyss-Coray, PhD, professor of neurology, Stanford University; co-founder, Alkahest.
Nature: “The Ageing Systematic Milieu Negatively Regulates Neurogenesis and Cognitive Function.”
JAMA Neurology: “Safety, Tolerability, and Feasibility of Young Plasma Infusion in the Plasma for Alzheimer Symptom Amelioration Study.”
National Library of Medicine: “Restoring Systemic GDF11 Levels Reverses Age-Related Dysfunction in Mouse Skeletal Muscle, 2014,” “Rejuvenation of ages progenitor cells by exposure to a young systematic environment.”
Transfusion Medicine and Hemotherapy: “Young Blood Rejuvenates Old Bodies: A Call for Reflection when Moving from Mice to Men.”
Open Medicine: “The Fountain of Youth: A Tale of Parabiosis, Stem Cells, and Rejuvenation.”
FDA: “Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions.”
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