In February, my colleague at the University of Minnesota, Leigh Turner, sent a letter to the FDA asking for an investigation of Celltex, the controversial adult-stem-cell company in Texas.  In response, attorneys for Celltex fired off a letter to the president of the university claiming that the letter had created “real and permanent harm to Celltex’s reputation.”  It asked what steps the University of Minnesota was taking to “disclaim sponsorship of the Turner letter” and remove it from the Internet.  That effort at intimidation generated a vigorous debate in the world of bioethics, some of it on this blog.  That debate followed controversy over the decision of Glenn McGee, the editor-in-chief of the American Journal of Bioethics, to become “president for ethics and strategic initiatives” at Celltex in December 2011.  (McGee resigned in February.)

The plot thickened yesterday with the release of the results of an FDA inspection of the Celltex facility.  (The inspection report was obtained through Freedom of Information Act requests from Turner and The Houston Chronicle.)  According to The Houston Chronicle, the Celltex facility is “rife with basic manufacturing problems” and the company “cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.”  The FDA inspectors found 79 separate deficiencies ranging from incorrectly labeled products to failed sterility tests, which a former FDA advisor says “are so serious that Celltex risks being shut down if it does not remedy the problems quickly.”

Obviously, one important question is whether the inspection will generate a warning letter from the FDA.  Judging from the reaction of the experts quoted in The Houston Chronicle, a warning letter seems likely.  According to Nature, these stem cells are already being injected into paying patients with serious illnesses, at prices up to $25,000.  As David Cyranoski of Nature writes, “Even if stem cells are produced through proper procedures, there are uncertainties over the safety of injecting them into people. The poor manufacturing record shown in the FDA document indicates that patients may have been subjected to much greater danger than necessary.”

Which raises a larger question: What impact will the FDA inspection have on the clinical activities in which Celltex cells are being used?  According to the inspection reports, the FDA is classifying Celltex as a “Biological Drug Manufacturer.”  Does this mean that the FDA will require that Celltex products be treated like biological drugs, with the strict regulatory requirements that this conventionally entails?  If so, this would be a serious blow to the business model of the company, which has argued to the FDA that it simply banks and processes stem cells “at the behest of independent physicians who diagnose and prescribe to their patients,” without submitting its products to the FDA for approval.  If the FDA demands evidence that adult stem cells actually work for the illnesses they are being used to treat, Celltex will have an uphill battle ahead.