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Tuesday, February 19, 2019

FDA: Taking blood from young donors not clinically proven to fight disease

February 19,  2019           By Tauren Dyson

The FDA has said plasma infusions from the blood of younger individuals is not clinicaly proven to fight diseases. File Photo UPI/Shutterstock/royaltystockphoto


Feb. 19 (UPI) -- Many older people are infusing young people's plasma into their bodies, but the U.S. Food and Drug Administration says there is no clinical benefit to the procedure.
The FDA issued the statement in response to the uptick of people receiving plasma infusions from young donors to fight aging or serious illnesses.
"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," said FDA Commissioner Scott Gottlieb and Peter Marks, head of the agency's biologics center, in a statement.
Plasma, or the liquid part of blood, is made up of proteins that help the blood clot. Plasma infusions have already been approved by the FDA in emergency trauma situations.
One study suggests older people who have younger blood infused can rejuvenate their body. The experiment in that study, however, was conducted on mice.
Ambrosia, a popular plasma infusion company, sold one liter of plasma for $8,000 in five states around the country from donors between ages 16 and 25, according to Business Insider. After the release of the FDA statement, however, the company posted the following statement on its site: "In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments."
The agency hasn't approved plasma infusions for Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, post‐traumatic stress disorder and heart disease, common conditions patients look to have treated. It says companies also offer the same stringent screening for the plasma that the FDA normally requires.
In fact, the agency warns that plasma infusions can transmit infectious diseases, cause allergic reactions and overload the body's circulatory system.
"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," the statement read. "Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful."
The FDA is calling on health professionals and patients to visit this site to report any negative reactions that stem from plasma infusions.
"As a general matter, 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 safe or effective for any use," the statement read.
    https://www.upi.com/FDA-Taking-blood-from-young-donors-not-clinically-proven-to-fight-disease/2811550603726/

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