Remember the Texas stem cell clinic Celltex, most famous for treating Texas Governor Rick Perry?
Celltex had a busy few years, but has been relatively under the radar for most of 2013. Does that mean it’s gone? Hardly.
The saga of Celltex became more serious when the FDA sent it a warning letter that was predicted by this blog.
Celltex was, according to the FDA, manufacturing an unapproved stem cell drug. The FDA apparently told the business to stop treating patients in the US unless a number of issues were resolved.
I’ve seen no indication in the public domain that the issues have been resolved up until now. As of July of this year the FDA told me that they were still investigating Celltex.
Back at the time of the FDA letter, Celltex was having its partner RNL Bio process and amplify customer’s stem cells. Since then Celltex and RNL Bio have broken up and RNL Bio out of Seoul Korea has imploded for various reasons.
What did Celltex do in response to the concerns of the FDA?
At least in part they seemed to have headed south to Mexico to “avoid the long arm of the law” of the FDA, as some patients have put it, to continue selling their stem cell interventions to customers.
American patients have self-reported this year about receiving stem cell interventions in Cancun from Celltex. For example, the group (update: note that some objected to my characterization of PFSC as “pro-Celltex so I have removed that–see comments section) that calls itself “Patients For Stem Cells” (or PFSC) posted on their Facebook page (above) about Celltex (also known as CellTex) continuing to sell stem cell interventions to Americans in Mexico. (update: PFSC folks told me that they also do not know why the thumbnail picture in their FB post was of a person self-immolating).
Some other self-described patients of Celltex have reported getting treatments in Mexico as well including on Twitter:
Direct inquiries to the company about the situation have received no reply.
However, the company gave a presentation at The Stem Cells and Regenerative Medicine Congress in October of this year indicating they had a presence in Mexico (see below).
Rumor has it that Celltex may have opened up its own stem cell manufacturing laboratory back in Texas recently. Again, the company isn’t talking publicly. However, Celltex is advertising for a Cell Manufacturing Laboratory Technician.
Also amongst its current Executive team, Celltex lists Hyeonggeun Park as Director of Manufacturing Laboratory and Dr. Jane S. Young, MD, PhD as Manufacturing Research Scientist.
So what’s going on?
Could Celltex be preparing for a new skirmish in its battle with the FDA or a turn toward compliance?
I hope it’s the latter, but it’s hard to know at this point.
In principle, I think it’s a smart move for Celltex to have its own lab and not depend on a potentially sketchy separate manufacturing partner of some kind. However, does it have permission from the FDA to have and run its own biological drug manufacturing facility?
Further, if Celltex is strictly treating American patients in Mexico and not in the US, but is producing the stem cell product from these people in Texas, how the heck is it exporting the human biological drugs (i.e. the stem cell product from its lab) to Mexico? Does it have FDA, CDC, and Customs permission for the export and is it paying the appropriate export fees that might apply?
Who knows, but to the best of my knowledge one cannot legally just “wing it” and export a human stem cell product from the US to Mexico without government permission from multiple agencies.
It seems to me that most likely we haven’t heard the last of Celltex or the FDA in regard to Celltex.