KUALA LUMPUR, Feb 19 – Using blood transfusions from young donors to combat aging and treat age-related diseases is unproven and could even be dangerous, the United States Food and Drug Administration (FDA) said in a strong warning.
The FDA said there was no proven clinical benefit in using young plasma to treat aging, memory loss, or other serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder.
“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,” FDA commissioner Scott Gottlieb and FDA’s Centre for Biologics Evaluation and Research director Peter Marks said in a statement yesterday.
Huffington Post reported that medical startups charged older patients thousands of dollars to inject them with young plasma that was dubbed as a miracle treatment.
The US portal reported last December a startup, Ambrosia, as claiming that young plasma reversed aging and came “pretty close” to providing immortality, but the company’s 34-year-old founder Jesse Karmazin has reportedly never shown evidence for his claims. Scientists also reportedly criticised Ambrosia’s study on the treatment — where 104 people paid to receive blood from 16- to 25-year old donors — and said the procedure was not without risk and was medically unnecessary.
Kamarzin reportedly announced in 2016 that people aged 35 and above would be charged US$8,000 each for about two litres of young plasma in what he described as a “clinical trial”. Ambrosia increased prices last December to US$12,000.
FDA said the use of plasma in the management of bleeding and clotting abnormalities has been proven, but pointed out the lack of clinical evidence on the efficacy of young plasma treatments, as well as the lack of information on the appropriate dose.
“Plasma is not FDA-recognized or approved to treat conditions such as normal aging or memory loss, or other diseases like Alzheimer’s or Parkinson’s disease. Moreover, reports we’re seeing indicate that the dosing of these infusions can involve administration of large volumes of plasma that can be associated with significant risks including infectious, allergic, respiratory and cardiovascular risks, among others,” said FDA.
The FDA also expressed concern that the marketing of young blood for such unproven treatments could discourage patients from receiving safe and effective treatments.
The FDA stressed that it would protect patients from “unscrupulous actors and unsafe products”.
“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.”