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Stem cells can be regulated as drugs, court says
September 2012
by Amy Swinderman  |  Email the author


WASHINGTON, D.C.—On July 23, the U.S. District Court for the District of Columbia ruled that the U.S. Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products—the latest event in a four-year battle between the agency and a Colorado company that uses stem cell therapies to aid in the healing of their orthopedic patients.
The ruling in the case, United States of America v. Regenerative Sciences LLC, et al., affirms the right of the FDA to regulate therapies made from a patient's own processed stem cells. Siding with the agency, U.S. District Court Judge Rosemary M. Collyer ruled that "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or articles (other than food) intended to affect the structure of any function of the body of man or other animals" do, in fact, fall under the FDA's interpretations. The judge also noted that her interpretation draws upon legal precedent and is "well established."  
The case began to unravel 2008, when the FDA issued a warning letter to Regenerative Sciences and its founders, Drs. Christopher J. Centeno and John R. Schultz, who developed the Regenexx procedure, which uses stem-cell therapies to aid in the healing of their orthopedic patients. During the procedure, stem cells are isolated from a patient's bone marrow, undergo an expansion in a laboratory and are then returned to the patient's site of injury to treat musculoskeletal and spinal injuries.  
The FDA's warning letter said the company's use of mesenchymal stem cells violated FDA regulations on "minimal manipulation," causing them to be drugs—a violation of the Federal Food, Drug, and Cosmetic Act (FFDCA). The defendants filed suit against the FDA, countering that they practice medicine wholly within the state of Colorado and under its oversight, and that the Regenexx procedure is not a "drug" subject to regulation by the federal government.  
According to the court, of critical importance to the case was the process by which Regenerative expands the mesenchymal cells taken from a patient's bone marrow and delivers a syringe with the cells in solution to the clinic. According to court documents, a doctor at the Centeno-Schultz Clinic in Broomfield, Colo., obtains a tissue sample from the patient's bone marrow by inserting a needle into the hip bone and drawing a thick, blood-like liquid into a syringe; the sample is then sent to the laboratory. The marrow sample is centrifuged to separate out fractions of the bone marrow and the middle layer ("buffy coat") is taken off with a pipette. The cells from the buffy coat are placed in a plastic flask and kept in a warm environment to incubate with the patient's own blood platelets that contain growth factors, as well as a nutrient solution. Over a few days, the mesenchymal stem cells adhere to the plastic flask, while the rest of the cells do not adhere. The non-adherent cells are discarded and the mesenchymal stem cells are collected using Trypsin, an enzyme, to detach the cells from the plastic flask. The process is repeated to grow the cells. The cells undergo a visual inspection by the Colorado Genetics Laboratory to make sure that there are no genetic mutations or other genetic problems. The treating doctor then approves the cells.
FDA investigators inspected Regenerative between February and April 2009, ultimately finding that the laboratory did not operate in conformity with current good manufacturing practice (CGMP) standards. The agency's inspection was repeated a year later, with the same conclusion.
While the initial FDA inspection was ongoing, Regenerative filed a complaint against the FDA in U.S. District Court for the District of Colorado, alleging that the FDA did not have the jurisdiction to regulate the autologous use of stem cells.  
"It is a close question, but ultimately, the court concludes that the Regenexx procedure is subject to FDA enforcement because it constitutes a 'drug' and because a drug that has been shipped in interstate commerce is used in the solution through which the cultured stem cells are administered to patients," Collyer ruled. "This acknowledged connection to interstate commerce renders the Regenexx procedure subject to the FFDCA even though the doctors themselves are practicing medicine under Colorado law."  
The court granted summary judgment to the plaintiff and issued an injunction precluding the continued use of the Regenexx procedure without compliance with the FFDCA. Officials from Regenerative Sciences have said they plan to appeal the ruling. The company agreed to stop using the Regenexx procedure during the pending litigation.
Code: E091226



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