Regenerative Sciences, LLC, a Colorado company run by physicians, created the Regenexx-C (Cultured) (“Regenexx-C”) procedure to treat bone pain. The procedure involves harvesting a patient’s own mesenchymal stem cells (MSCs), expanding the cells ex vivo, and then injecting the resulting cellular product into the site of injury, usually an injured joint. The MSCs then repair the damaged tissue. On July 23, 2012, the United States Food and Drug Administration (FDA) won a permanent injunction against Regenerative Sciences in district court, preventing the company from offering the procedure because the MSCs were adulterated and misbranded “drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA). The Court of Appeals for the D.C. Circuit recently upheld the ruling.