Regenerative Sciences gene/cell therapy, musculoskeletal news
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 LLC that the Cultured Regenexx Procedure (Regenexx-C) from Regenerative 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. The company promotes it to treat a variety of musculoskeletal ailments.
The court rejected Regenerative's argument that Regenexx-C is a "procedure of medicine" not subject to FDA regulation, ruling that the agency is regulating the MSC mixture, not the procedure. Regenerative also argued that an exemption from FDA's authority over cell products for cells that are "minimally manipulated" applied to Regenexx-C, an argument the court rejected as the culturing process "alters relevant biological characteristics" of the cells. ...