Stem cells can be regulated as drugs, court says
Judge sides with FDA in four-year battle over stem cell therapy use by Colorado company
WASHINGTON, D.C.—On July 23, the U.S. District Court for theDistrict of Columbia ruled that the U.S. Food and Drug Administration (FDA) maylegally regulate stem cell therapies as drug products—the latest event in afour-year battle between the agency and a Colorado company that uses stem celltherapies to aid in the healing of their orthopedic patients.
The ruling in the case, United States of America v.Regenerative Sciences LLC, et al., affirmsthe right of the FDA to regulate therapies made from a patient's own processedstem 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 otheranimals" do, in fact, fall under the FDA's interpretations. The judge alsonoted that her interpretation draws upon legal precedent and is "wellestablished."
The case began to unravel 2008, when the FDA issued a warningletter to Regenerative Sciences and its founders, Drs. Christopher J. Centenoand John R. Schultz, who developed the Regenexx procedure, which uses stem-celltherapies to aid in the healing of their orthopedic patients. During theprocedure, stem cells are isolated from a patient's bone marrow, undergo anexpansion in a laboratory and are then returned to the patient's site of injuryto treat musculoskeletal and spinal injuries.
The FDA's warning letter said the company's use ofmesenchymal stem cells violated FDA regulations on "minimal manipulation,"causing them to be drugs—a violation of the Federal Food, Drug, and CosmeticAct (FFDCA). The defendants filed suit against the FDA, countering that theypractice medicine wholly within the state of Colorado and under its oversight,and that the Regenexx procedure is not a "drug" subject to regulation by thefederal government.
According to the court, of critical importance to the casewas the process by which Regenerative expands the mesenchymal cells taken froma patient's bone marrow and delivers a syringe with the cells in solution tothe clinic. According to court documents, a doctor at the Centeno-SchultzClinic in Broomfield, Colo., obtains a tissue sample from the patient's bonemarrow by inserting a needle into the hip bone and drawing a thick, blood-likeliquid into a syringe; the sample is then sent to the laboratory. The marrowsample is centrifuged to separate out fractions of the bone marrow and themiddle layer ("buffy coat") is taken off with a pipette. The cells from thebuffy coat are placed in a plastic flask and kept in a warm environment toincubate with the patient's own blood platelets that contain growth factors, aswell as a nutrient solution. Over a few days, the mesenchymal stem cells adhereto the plastic flask, while the rest of the cells do not adhere. Thenon-adherent cells are discarded and the mesenchymal stem cells are collectedusing Trypsin, an enzyme, to detach the cells from the plastic flask. Theprocess is repeated to grow the cells. The cells undergo a visual inspection bythe Colorado Genetics Laboratory to make sure that there are no geneticmutations or other genetic problems. The treating doctor then approves thecells.
FDA investigators inspected Regenerative between Februaryand April 2009, ultimately finding that the laboratory did not operate inconformity with current good manufacturing practice (CGMP) standards. Theagency's inspection was repeated a year later, with the same conclusion.
While the initial FDA inspection was ongoing, Regenerativefiled a complaint against the FDA in U.S. District Court for the District ofColorado, alleging that the FDA did not have the jurisdiction to regulate theautologous use of stem cells.
"It is a close question, but ultimately, the court concludesthat the Regenexx procedure is subject to FDA enforcement because itconstitutes a 'drug' and because a drug that has been shipped in interstatecommerce is used in the solution through which the cultured stem cells areadministered to patients," Collyer ruled. "This acknowledged connection tointerstate commerce renders the Regenexx procedure subject to the FFDCA eventhough the doctors themselves are practicing medicine under Colorado law."
The court granted summary judgment to the plaintiff andissued an injunction precluding the continued use of the Regenexx procedure withoutcompliance with the FFDCA.
Officials from Regenerative Sciences have said they plan toappeal the ruling. The company agreed to stop using the Regenexx procedureduring the pending litigation.