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.
A doctor takes bone marrow and blood samples from a patient, isolates stem cells and then grows new ones, which are all injected back into the patient's injured area after they are approved. "The repair process usually takes between 3-6 months but many patients demonstrate marked improvement within 1-3 months," the ruling states. In August 2010, Regenexx accounted for about one-third of the procedures performed by the Colorado-based clinic. Though the practice argued that Regenexx "constitutes the practice of medicine as defined by Colorado law," and that the FDA lacked jurisdiction to regulate it, Collyer disagreed. "Although defendants agreed to stop using their Regenexx procedure during the pendency of this lawsuit, there remains a 'cognizable danger of recurrent violation,'" she wrote.
See Forbes article.
Adapted from the Courthouse News Service announcement.