Injunction on Stem-Cell Treatment Upheld

     (CN) – A stem-cell treatment to rebuild hips, knees and other joints is a drug, not just a medical procedure, the D.C. Circuit ruled, finding its maker responsible for misbranding the product.
     Dr. Christopher Centeno and Dr. John Schultz practice medicine together at the Centeno-Schultz Clinic in Colorado, where they jointly developed a procedure called Regenexx to treat orthopedic conditions. They market Regenexx through their company Regenerative Sciences.
     The procedure extracts a sample of a patient’s bone marrow, isolates stem cells from the marrow, and cultures them, so that they grow and proliferate.
     That stem-cell solution is then combined with an antibiotic, docycycline, and reinjected into the patient at the site of his injury.
     Promotional materials for Regenexx recommend the procedure for treating osteoarthritis, bulging lumbar discs, nonhealing bone fractures, and soft-tissue injuries.
     In a 2010 federal complaint , the United States said the stem-cell product should be considered a drug, not just a procedure, under the Food, Drug, and Cosmetic Act.
     “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,” the complaint stated.
     Centeno told Courthouse News at the time that “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.”
     He claimed that labeling a patient’s own stem cells as a drug will “hugely increase” patient costs.
     A federal judge nevertheless granted the government summary judgment and entered an injunction, and the D.C. Circuit affirmed both orders Tuesday.
     “Appellants’ principal argument is that the mixture is not subject to regulation under the FDCA or PHSA [Public Health Service Act] because it is neither a drug nor a biological product but is, rather, a medical procedure,” Judge Thomas Griffith wrote for a three-judge panel. “The text of those statutes forecloses this argument.”
     While there is a regulatory exception from the FDA’s manufacturing and labeling requirements for “minimally manipulated” drugs, Regenerative Sciences admitted that the culturing process of stem cells “is designed to ‘determine the growth and biological characteristics of the resulting cell population,'” according to the ruling.
     “It is also undisputed that, in at least some cases, appellants add substances to the cell culture that affect the differentiation of bone marrow cells,” the 19-page opinion states.
     Griffith said the court reached its ruling based on the FDA’s regulations themselves, not the agency’s statement in the preamble that says, “We do not agree that the expansion of mesenchymal cells in culture … [is] minimal manipulation.”
     In upholding the permanent injunction, Griffith cited Regenerative Science’s numerous violations and failure to improve its manufacturing process after receiving FDA warnings.

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