Celltex is a clinic down in Texas most famous for isolating and growing up the stem cells that were given as a transplant to Texas Governor and one time GOP candidate for president, Rick Perry.
The FDA audited Celltex in April for two weeks.
Based on the audit of Celltex, the FDA issued a 483 form explaining 79 individual concerns to Celltex about their operations.
79 is a big number, but a bigger number is 80 and that is reportedly the number of additional patients, at a minimum, that have received stem cell treatments via Celltex. These treatments have apparently occurred without Celltex first going through the steps typically required by the FDA prior to even treating one patient with a drug.
But, wait a minute, is the Celltex stem cell product a drug?
The FDA is very careful and meticulous so their use of the phrase “Biological Drug Manufacturer” to refer to Celltex in their 483 audit form (see snapshot above) was not accidental and the simplest interpretation of that is that they do indeed view the Celltex product as a drug.
From one perspective, the future of Celltex seems to rest on convincing the FDA that its stem cell product is not a drug at all.
After the 483 audit report went public, Celltex issued a press release explaining their take on the situation and arguing that a language barrier explained some of the problems since its Texas clinic is run by Korean nationals employed by RNL Bio, which importantly has itself subsequently been sued for fraud related to stem cell treatments independent of their partnership with Celltex (not named in the suit).
The Celltex press release also suggested that the FDA has already given them in essence a green light as a producer not of a stem cell drug, but rather a so-called HCT/P. The key passage from the press release is the following:
Some media reports and social media chatter suggest that Celltex is somehow acting illegally or providing unapproved treatments. These statements are inaccurate. Celltex is registered with the FDA as a facility that multiplies human cells and cellular products (HCT/Ps); in particular, adult mesenchymal stem cells. The FDA does not require a company to obtain FDA approval prior to distribution of its HCT/Ps. 21 CFR Part 1271. In addition, the FDA does not issue “licenses,” so any reference that Celltex provides “unlicensed” procedures is inaccurate. Celltex’s process for reproducing adult mesenchymal stem cells is legal, and there is no requirement that the cells be approved or licensed.
If the Celltex product is indeed a drug in the FDA’s opinion, which seems likely (even if still not certain) since the FDA called them a “drug manufacturer”, then the assertions in this press release may be overly simplistic.
Further, if the FDA believes that Celltex is producing a drug, then in fact the FDA does require a company to obtain approval prior to distributing said drug to doctors to inject into patients.
So in many ways it would seem that Celltex’s future could hinge on the interpretation of one small word: drug.
Is it a drug or isn’t it?
I don’t know as I can’t read the FDA’s mind, but I have a feeling we’ll find out pretty soon.
Stay tuned tomorrow for a post laying out some of the possible scenarios for Celltex and the FDA moving forward.