Gottlieb and Marks said none of the plasma treatments has gone through the rigorous testing required by the agency. Ambrosia says “experiments in mice called parabiosis provided the inspiration to deliver treatments with young plasma.” The FDA approval typically requires human trials before companies can make a specific health claim about a product. Plasma infusion is an approved use by the FDA in trauma settings or in patients whose blood doesn’t coagulate. “We’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies,” Gottlieb and Marks said. “Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them, and are potentially harmful.”

Source: National Post February 19, 2019 16:52 UTC