U.S. Federal Court Says Stem Cell Treatments Are Drugs
A U.S. federal court has found that a stem cell therapy offered by a Colorado clinic meets the definition of a regulated drug. The ruling could spur a U.S. Food and Drug Administration crackdown on other clinics offering untested adult stem cell treatments in the United States.
The company, Regenerative Sciences Inc. in Broomfield, Colorado, uses stem cells extracted from a patient’s own bone marrow to treat bone and joint injuries. The company says its treatment is a medical procedure and not subject to federal oversight. But in a 2010 suit seeking to block the company from selling the treatment, the U.S. government argued that because Regenerative Science’s stem cells are more than “minimally manipulated” and use reagents that cross state lines, the cells are an FDA-regulated biological drug.