Startup selling blood from young donors crumbles under FDA scrutiny
A startup that sold young donors’ blood to consumers in several states with the goal of treating conditions such as dementia, Alzheimer’s disease and heart disease has apparently shut down in the wake of an FDA statement that the blood-infusion technique has no scientific merit.
“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,” wrote FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of the agency’s Center for Biologics Evaluation. “Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful.”
The potential harms include allergic reactions and transfusion-associated circulatory overload, which are possible risks even for approved uses of plasma administration, according to the statement.
Gottlieb and Marks didn’t mention Ambrosia Health by name in the statement, but that company subsequently posted the following on its website: “In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments.”
The Monterey, California-based company was previously charging $8,000 for intravenous infusions of one liter of plasma from donors between 16 and 25 years old, and $12,000 for two liters, according to the Houston Chronicle.
The Chronicle reported Ambrosia had been treating patients since 2016 at its initial sites in Florida and California, and expanded to offer services in Houston, Phoenix and Omaha, Nebraska, early this year. Founder Jesse Karmazin told the Chronicle in mid-January Ambrosia Health had treated about 150 patients overall with the blood infusions, included 100 in a clinical trial for which participants paid the full price for the therapy.
Read more from the Houston Chronicle below:
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.