The U.S. Food and Drug Administration issued a warning Tuesday, Feb. 19, warning older consumers not to seek infusions of blood plasma harvested from younger people. Despite being marketed as anti-aging treatments and cures for a range of conditions, the transfusions are unproven and potentially harmful.
In a statement, FDA Commissioner Scott Gottlieb and the director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, wrote:
Simply put, we are concerned that some patients are being harassed by unscrupulous actors who tout treatments of plasma from young donors as cures and remedies.
Branches in several states now sell young blood plasma, the liquid part of blood that contains proteins for clotting. The vendors suggest that doses of young plasma could treat conditions ranging from normal aging and memory loss to dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder, the FDA said.
The claims are wild extrapolations from intriguing but preliminary findings in mouse studies. Over the years, rodent experiments have hinted that components of young mouse blood can stimulate older mice, possibly as an anti-aging treatment. However, the results are inconclusive, controversial and, most importantly, not proven to be relevant to human health.
The FDA further notes that such infusions are known to pose a range of health risks in humans. These risks include spreading infectious diseases, causing allergic reactions and causing lung injury. In some people — especially those with heart disease — the infusions can also overload circulation, causing swelling and difficulty breathing, the agency explains.
While the FDA didn’t name specific infusion companies in its warning, one that has received a lot of media attention is a startup called Ambrosia. It has locations in Phoenix, Arizona; Los Angeles, California; Tampa, Florida; Omaha, Nebraska; and Houston, Texas, according to the company’s website. Customers 30 and older can make an infusion appointment for plasma harvested from healthy donors aged 16 to 25. A single liter costs $8,000, while two liters cost $12,000. Neither is covered by insurance.
The company conducted a clinical trial of its infusions in 2016, which was completed last year. The trial involved 200 patients aged 35 or older and would assess blood biomarkers associated with aging and certain diseases, including “anemia, neutropenia, thrombocytopenia, obesity, diabetes, high cholesterol, increased risk of cancer, atherosclerosis, dementia and stare.”
It’s unclear how the trial went or whether the company has released the results. Ambrosia’s website simply states that a trial “studied the benefits of young plasma.”
Ambrosia did not respond to Ars’s request for comment.
In their statement, Gottlieb and Marks added that if they find that young blood companies are misleading consumers, they were willing to take “regulatory and enforcement action.”
[UPDATE, 2/19/2019, 7:30ET:] Ambrosia announced on its website that “in accordance with the FDA announcement of February 19, 2019, we have discontinued patient treatments.”