Court reaffirms FDA authority over autologous cells

FDA has authority to regulate some autologous stem cell procedures, according to a ruling from the U.S. Court of Appeals for the District of Columbia. The appeals court upheld a decision in USA v. Regenerative Sciences that the Cultured Regenexx Procedure (Regenexx-C) from Regenerative Sciences LLC (Broomfield, Colo.) is both a drug and biological product and thus is subject to FDA regulation. According to court documents, Regenexx-C involves cultured mesenchymal stem cells (MSCs) derived from a patient's own bone marrow or synovial fluid that are combined with an antibiotic and injected back into the patient. Regenerative promotes it to treat a variety of musculoskeletal ailments.

The appeals court rejected Regenerative's argument that Regenexx-C is a "procedure of medicine" and not subject to FDA regulation, ruling that FDA is regulating the MSC mixture and not the procedure. The court also rejected Regenerative's argument that Regenexx-C was exempt from FDA's authority because it is a "minimally manipulated" cell product. The court said the culturing process "alters relevant biological characteristics" of the cells. ...