Dieter Egli was just about to start graduate school in 1998 when researchers first worked out how to derive human embryonic stem cells. In the two decades since, the prolific cells have been a fixture of his career. The biologist,...
Will the FDA Close Down Celltex?
In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.This story has been building for months (see our previous coverage 1, 2, 3, 4) and is by no means over. The FDA report cataloged 14 "general observations about the ways in which Celltex cell-manufacturing procedures are not up to scratch" (David Cyranoski in Nature) and 79 specific problems, but essentially offers the company an opportunity to respond, point by point. However, there is an even more important general point, as Cyranoski also notes:
For the time being, the FDA seems to be approaching Celltex just as a stem-cell manufacturer — the observation form calls it a “biological drug manufacturer”. But the clinical use is a separate problem. Another shoe is yet to drop.It is not clear what specifically prompted the FDA investigation, but it is no secret that University of Minnesota professor Leigh Turner called for one back in February, provoking a storm that included threats of lawsuits against Turner and his colleague Carl Elliott, who wrote about the issue in an article that Slate retracted under pressure. It seems fair to say, with the Twin Cities Star Tribune that:
FDA inspectors back U prof who blew whistleTurner explains the significance of the reference to Celltex as a biological drug manufacturer:
This label is important because it indicates that FDA regards Celltex as engaged in manufacture of mesenchymal stem cells —biological drugs — rather than providing access to minimally manipulated stem cells. ... I worry that in addition to paying $20,000 to $30,000 for stem cells that have not be subjected to proper evaluation within clinical trials, could harm them, and provide no assurance of benefit, [patients] are being exposed to risks that are avoidable if good manufacturing practices are followed.If Celltex products are treated as biological drugs, notes Elliott,
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.This time, Celltex is trying a public relations rather than a legal response, at least for the moment. Their line is:
Celltex's laboratory is currently operated by its licensing partner RNL Bio (dba Human Biostar), with lab technicians and scientists from RNL's Seoul, Korea headquarters. The main issues in the FDA observations arose from a language barrier. RNL scientists extensively document procedures, including validations, but they are recorded in Korean and were not able to be provided in English to FDA during its visit.But now they have translated them, so everything will be copacetic.
A more telling observation comes from Texas Governor Rick Perry, who was himself a patient of Celltex co-founder Dr Stanley Jones; who was indeed the first customer of Celltex; who proposed that stem-cell treatments would boost the state economy; who was instrumental in encouraging new rules in Texas that allow the use of stem cells in treatments under review board approval. How did he react to the latest news?
His spokewoman called the report an issue “between the company and FDA.”Celltex is in big trouble if Perry is jumping ship.
Previously on Biopolitical Times: