FDA warns about plasma infusions

The US Food and Drug Administration is warning that infusions of plasma from young donors aren't the fountain of youth and potentially dangerous to those receiving the blood.

Commercial clinics had offered plasma at about $8,000 per infusion. The infusions were purportedly effective in treating a range of conditions, including memory loss, dementia, Parkinson's disease, multiple sclerosis, Alzheimer's disease, heart disease, normal aging and post-traumatic stress disorder.

"There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat or prevent these conditions," Dr Scott Gottlieb, FDA commissioner, and Peter Marks, director of the agency's Center for Biologics Evaluation and Research, said in a joint statement.

"Simply put, we're concerned that some patients are being preyed upon by unscrupulous actors. The promotion of plasma for these unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments that may be available. We strongly urge individuals to consult their treating physician."

The FDA said it hasn't tested use of plasma from young donors in clinical trials, and, therefore, plasma infusions intended to treat disease or slow aging shouldn't be assumed to be safe or effective.

Plasma is the liquid portion of the blood. It contains proteins that helps blood clot and can be used to manage bleeding and clotting abnormalities. The benefits of plasma have long been recognized, especially in treating traumatic injuries.

"For those patients receiving a plasma product for a recognized use, the benefits of treatment …outweigh its risks," the doctors said.

Risks, include allergic reactions and transfusion associated with "circulatory overload", acute lung injury or infectious disease transmission, the FDA said.

A San Francisco startup named Ambrosia — named for the drink of the ancient Greek gods and said to impart longevity or immortality to mortals who consumed it — stopped offering plasma infusions after the FDA said the procedure was unproven. The company had opened offices in Los Angeles, Houston, Texas; Phoenix, Arizona; Tampa, Florida; and Omaha, Nebraska.

The cost: $8,000 for a liter of plasma and two liters for $12,000.

Researchers at Duke University discovered that blood from younger mice helped older mice heal bone fractures faster than normal.

In 2014, researchers at the University of California, San Francisco injected the plasma of 3-month-old mice into 18-month-old mice and found that the older mice performed significantly better after the infusion. A mouse's life span is about 24 months.

Researchers at both universities cautioned that plasma is just one element in the field of regenerative medicine and dismissed claims that plasma infusions would help humans because the research is in its early stages, and humans are more complex than mice.

The FDA said anyone promoting blood infusion as a cure could face legal consequences.

"We support sound, scientific research and regulation of medical treatments," the doctors at the FDA said. "We will use our tools and authorities to protect patients from unscrupulous actors and unsafe products.

"We will consider taking regulators and enforcement action against companies that abuse the trust of patients and endanger their health by promoting so-called 'treatments' that haven't been proven safe or effective for any use."