WASHINGTON (CN) – The Department of Justice says a stem-cell treatment to rebuild hips, knees and other joints has been misbranded by its manufacturer, Regenerative Sciences, and violates standards of the federal Food, Drug, and Cosmetic Act.
Colorado-based Regenerative Sciences calls the cultured stem cells used in the company’s Regenexx procedure a “cultured cell product,” while the FDA claims the cell product should be considered a drug. The Regenexx procedure involves taking cells from a patient’s bone marrow, processing the cells with the patient’s blood, then reinjecting the “product” into the patient.
The cultured cells should be classified as a drug, the government says, as they end up in a syringe to be injected back into the patient.
“Defendant’s cultured cell product is a ‘drug’ within the meaning of the FDCA, because Defendant’s labeling and promotional literature, including information contained on Regenerative Sciences’ website, establish that their cultured cell product is intended to be used in the cure, mitigation, and treatment of diseases in man and to affect the structure and function of the body,” says the government in its complaint.
Dr. Christopher Centeno, Regenerative Sciences’ acting CEO and defendant in the case, disputes the FDA’s claims that the product is a drug.
“This is about patients. We don’t dislike [the FDA] and respect its authority over drug production. However, we also believe a physician has the right to use stem cells or other body parts to help heal the patient, especially when it’s a better alternative to more invasive procedures,” says Dr. Centeno.
He says making a patient’s own stem cells a drug “won’t add measurable safety, but it will hugely increase cost and delay helping patients find better options for their medical problems.”
According to the FDA, if the cultured cell product is a drug, then Regenerative Sciences is not following the guidelines of “current good manufacturing practice.” The agency says its nearly two-month investigation of the company’s Colorado facilities “showed that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the cultured cell product do not conform to and are not operated or administered in conformity with current good manufacturing practice.”
Among the violations, the FDA says, Regenerative Sciences failed “to perform appropriate laboratory testing of each batch of drug product required to be free of objectionable microorganisms.”
The government says the company promised to correct some violations, “but they refused to correct many others because they do not believe that Regenerative Sciences is a drug manufacturer.”
“Regenerative Sciences has had an exemplary safety record, showing that our procedure is far safer than the knee replacements it has helped patients avoid,” Centeno says.
The company has sued the FDA four times in two years, trying to get a decision that the cultured cell product is “the practice of medicine” and not a drug, he explained in an interview with Courthouse News.