Stem cell therapy for orthopedic patients constitutes a drug, opening manufacturers to liability for adulteration and misbranding, a federal judge ruled.
The U.S. government sued Regenerative Sciences and its founders, Drs. Christopher Ceneno and John Schultz, in 2010 over the treatments, which involve isolating mesenchymal stem cells from a patient's bone marrow and allowing the cells to multiply before pumping them back into a patient.
The Food and Drug Administration has argued since 2008 to classify the procedure as a drug, subject to Federal Food, Drug and Cosmetic Act regulations. FDA investigators also found that the Regenerative's facilities did not conform with good manufacturing practice. The company tried to fight federal jurisdiction, but U.S. District Judge Rosemary Collyer granted summary judgment for the government on Monday.
"It is a close question but ultimately the court concludes that the Regenexx Procedure is subject to FDA enforcement because it constitutes a 'drug' and because a drug that has been shipped in interstate commerce is used in the solution through which the cultured stem cells are administered to patients," she wrote.