The FDA cautions patients to undergo only approved stem cell treatments.
Due to a rising and mostly unregulated trend of marketing stem cell treatments for an increasing variety of diseases and conditions, the US Food and Drug Administration (FDA) early last month issued a warning advising patients to ensure they are receiving federally approved stem cell therapies.
Direct-to-consumer internet marketing and medical tourism have allowed an increasing number of vendors to offer stem cell therapies for a vast array of conditions that have no viable treatment options. While the FDA regulates interstate commerce of stem cell treatment products, the agency realistically cannot reach every clinic-specific procedure around the world. Numerous clinics, especially those in other countries, offer independently developed stem cell treatments that fall outside of the FDA’s oversight.
The FDA warning emphasizes potential risks of stem cell therapies and advises patients to only pursue federally approved treatments or experimental procedures. The warning notes that only one stem cell product has been approved by the FDA to date.
The agency’s announcement also highlighted a recent federal indictment accusing three individuals of illegally harvesting cord blood stem cells, advertising treatments for incurable diseases such as cancer and multiple sclerosis, and receiving more than $1.5 million from willing patients. The owner of a laboratory involved in the case has been convicted and faces fines and imprisonment.
Stem cells are capable of generating new, healthy cells that could potentially be used to replace damaged or diseased cells occurring in a wide variety of pathologies.
