In a warning to consumers on Tuesday, the US Food and Drug Administration (FDA) said consumers should be cautious about establishments offering infusions of plasma obtained from young human donors with the claim that the infused plasma will prevent aging or memory loss.
At a cost of up to thousands of dollars per infusion, FDA said these establishments, located in several different states, are currently offering such infusions of plasma with no proven clinical benefit.
For instance, a startup called Ambrosia, which has five clinics, including in Phoenix and Los Angeles, offers such treatments for $8,000 for one liter and $12,000 for two liters
, although scientists called
the pay-to-participate trial a scam. However, in an update on Tuesday afternoon, said: "In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments."
FDA Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research Director Peter Marks said
: "The reported uses of these products should not be assumed to be safe or effective. We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight."
FDA also notes establishments are claiming that blood transfusions can prevent not only aging or memory loss, but can treat such conditions as dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder.
“The dosing of these infusions, which can involve large administered volumes, is also not guided by evidence from adequate and well controlled trials. In addition, the infusion of plasma can be associated with infectious, allergic, respiratory, and cardiovascular risks, among others,” FDA said. “In some individuals, particularly those with preexisting heart disease, the infusion of plasma can cause overload of the circulatory system leading to swelling of the body and difficult breathing.”
Gottlieb and Marks added: "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."
In a note to health care providers, the agency also said the FDA-recognized Circular of Information for the Use of Human Blood and Blood Components published by AABB lists the following indications for the administration of plasma:
Important Information about Young Donor Plasma Infusions for Profit
Editor's note: Article updated on 2/19 to note Ambrosia's comment on its website.
- “Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors (e.g., liver disease, disseminated intravascular coagulation)
- Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
- Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect
- Transfusion or plasma exchange in patients with thrombotic thrombocytopenic purpura
- Transfusion or plasma exchange with selected coagulation factor deficiencies, congenital or acquired, for which no specific coagulation concentrates are available
- Management of patients with rare specific plasma protein deficiencies, when recombinant products are unavailable.”