In a statement on its website, Ambrosia Health said it had ceased the procedures "in compliance with the FDA announcement issued February 19, 2019". Amid the increasing popularity of this supposed anti-aging treatment, the FDA raised the red flag on the promotion and use of plasma from young donors for different health conditions because the treatment has not yet been scientifically proven effective. He added that the FDA strongly discourages the use of such treatment unless done in supervised clinical trials.
Karmazin said last month that Ambrosia's clinical trial, which treated about 100 patients with one dose of plasma each, wrapped up about a year ago. Business Insider reported, "As of September, the company had infused close to 150 people, ranging in age from 35 to 92, with the blood of younger donors, Cavalier said".
Blood plasma itself is approved for transfusions and is life-saving for people who have lost a lot of blood, have liver disease or have had heart surgery and are low on certain critical blood proteins.
While the FDA did not name Ambrosia in its release, it cautioned consumers that there is "no proven clinical benefit" to the transfusions.
Companies offering the "treatment" claim (without evidence) that the young blood can treat anything from dementia and Alzheimer's to heart disease and post-traumatic stress disorder (PTSD). Gottlieb said that large volumes of plasma could be associated with telling risks, which include cardiovascular and respiratory reactions, allergies, and infections.
"We will use our tools and authorities to protect patients from unscrupulous actors and unsafe products", they write, going on to promise action 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". A major problem with this was not only the inherent risks of getting a blood plasma transfusion from an unknown donor, there is also the lack of human studies that proves this treatment works.
One company, Ambrosia, has already stopped treatments.
A handful of experiments, studies and his own intuition were enough to convince Dr Jesse Karmazin that young-blood might be a cure-all.
A growing number of clinics across the USA offer infusions of plasma specifically from young donors-peddled as anti-aging treatments and cures for disease. Nevertheless, said Drs. Gottlieb and Marks in a statement, "We're concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies".