A US federal court has ruled that a stem cell product is classified as a 'drug', falling under the jurisdiction of the Food and Drug Administration (FDA). The ruling allows the FDA to regulate stem cell therapy in the USA and could open clinics that offer stem cell treatments to federal liability.
The FDA took legal action against Regenerative Sciences, a clinic based in Broomfield, Colorado, in 2010 over its treatments involving mesenchymal stem cells. It sought an injunction to prevent the clinic from offering what it said were unapproved treatments that were not shown to be effective in clinical studies. The FDA also claimed that the facilities at Regenerative Sciences did not meet its standards.
The clinic challenged the FDA's jurisdiction to regulate its orthopaedic treatment, Regenexx, on the grounds that the procedure used patients' own stem cells, which were harvested, manipulated, and injected back into the same patient. The company argued as the cells were not significantly modified during the procedure it should be categorised as a routine treatment and therefore not subject to federal regulation by the FDA.
Although Regenerative Sciences agreed to stop offering Regenexx during the proceedings, US District Judge Rosemary Collyer, who gave judgment in favour of the FDA, said there remained a 'cognisable danger of recurrent violation'.
'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', said Judge Collyer in granting the permanent injunction against Regenerative Sciences. The court ruling now means that any cells that undergo more than 'minimal manipulation' are subject to federal regulations.
Commenting on the ruling, Dr Christopher Centeno, medical director of Regenerative Sciences said: 'This is really round one. Our position remains that a patient's cells are not drugs'. He told Nature News that he intends to appeal the decision.
Christopher Scott, of the Center for Biomedical Ethics at Stanford University, California welcomed the decision, however. 'I think it's a good ruling, and I'm glad to see that that the FDA has exercised its muscle on the case', he said.
A statement on the Regenexx webpage reads: 'This battle is largely about who has the right to regulate an individual's body. The FDA took the position that the cells in your body, under certain circumstances, are prescription drugs. The physician practice behind the Regenexx procedures has challenged in court this ''Your cells = drugs'' policy'.
Many medical professionals, including Scott, want the FDA to step in and regulate stem cell therapies, especially since their effectiveness is as yet unproven. On the other hand, some commentators fear FDA control will limit stem cell therapies so that people will seek riskier treatment elsewhere.