A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and tissue products.
That debate, at least operatively, would seem to be over with a ruling today by the federal D.C. Court of Appeals supporting the FDA position that stem cells grown in a lab are in fact drugs. The decision came on an appeal of a lower district court ruling in USA v. Regenerative Sciences case, which had also supported the FDA position.
Judge Griffith, writing for the majority of the Appeals Court:
GRIFFITH, Circuit Judge: In this civil enforcement action, we must decide whether the appellants—three individuals and a related corporate entity—violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient’s stem cells and the antibiotic doxycycline. Because we conclude that they did, we affirm the district court’s judgment and the permanent injunction it entered against appellants.
The Court also described the Regenerative Sciences procedure:
The Procedure begins with the extraction of a sample of a patient’s bone marrow or synovial fluid. From that sample, Regenerative Sciences isolates mesenchymal stem cells (MSCs), which are capable of differentiating into bone and cartilage cells. The MSCs are then placed in a solution to culture them—that is, to cause them to divide and proliferate.
Other substances are sometimes added to the solution that affect the MSCs’ differentiation. The culturing process determines the growth and biological characteristics of the resulting cell population. When the MSCs are sufficiently numerous for re-injection, they are combined with doxycycline, an antibiotic obtained in interstate commerce and used to prevent bacterial contamination of the MSCs. The resulting mixture (the Mixture) is injected into the patient from whom the stem cell sample was initially taken, at the site of the damaged tissue.
In its ruling the Court emphasized it was not simply deferring to the FDA opinion on the matter, but made the ruling based on evidence.
I asked Dr. Chris Centeno, the leader of Regenerative Sciences, a few questions about his reaction to today’s ruling.
What’s your take on the ruling? Centeno: The DC Circuit agreed with the FDA’s position. Not much more to it.
Was it just a “yes/no” kind of situation or are there subtleties to what the court said? Centeno: They basically said that a physician producing what the FDA considers a drug (in our case culturing autologous MSCs) is subject to FDA federal drug rules and isn’t practicing medicine.
What’s next for Regenerative Sciences? Appeal to Supreme Court? What would that entail? Centeno: We will abide by their ruling as we have done since August of 2010. At that time we got our first written indication of a formal FDA position and we complied by no longer culturing cells at our Colorado medical practice. We will make every effort to continue to comply and we will not pursue appeal to the Supreme Court.
The ruling along with Dr. Centeno’s indication of there most likely being no further appeal would seem to cement as the law of the land that propagated stem cells, even when used in an autologous context, are drugs, particularly when mixed with other substances or in other ways more than minimally manipulated. This development confirms my #8 prediction for the stem cell field for 2014 and I support this ruling.