Celltex & its IRB provider both get serious FDA warning letters: Celltex response to my inquiry

Sugarland, Texas stem cell clinic, Celltex, is most well known for having done the stem cell treatment on Texas Governor Rick Perry.

What’s up with Celltex this week?

There has a lot of talk behind the scenes that something big has happened.

Very recently Celltex put out a PR recently saying it had received a “letter” from the FDA.

What exactly was this letter? An untitled letter or a more serious “warning letter” as I speculated on October 1?

It was indeed a warning letter.

We know now that Celltex received an FDA warning letter on September 24 (you can read it here) containing dozens of issues of serious concern for the FDA.

Adding to the potential woes for Celltex, the FDA also sent a warning letter (here) to the Celltex IRB provider, Texas Applied Biomedical Services.

What did the Celltex warning letter say? It was long and all bad news for the company. The FDA outlined 29 major points of concern, some containing subsections as well. The FDA also made clear that the Celltex stem cell product is a drug and that Celltex needs to have a BLA and an IND. Quoting the letter:

The CellTex AdMSC product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, your product violates the FDC Act and the PHS Act.

At this point, what does this mean for Celltex?

The FDA has increased the pressure on Celltex to come into compliance. In Celltex’s recent PR it indicated some steps in the right direction, but a critical question is whether Celltex can continue to treat patients given this warning letter. Some sources from Texas have indicated that Celltex has recently canceled some patient appointments, but I was unable to confirm that.

I contacted Celltex directly regarding the letter (at the time of my contacting them I did not know for sure it was a warning letter, but had kinda guessed it was) and the rumors of them having to shutdown operations due to the FDA.

Madison Mauzé, Vice President Business Development, kindly responded to my email yesterday:

Paul,   Thank you for your continued interest in Celltex. No, the FDA has not shut down our operations.  As we mentioned in the press release on October 1, 2012, we are initiating new clinical programs.  In light of the recent letter from the FDA, we are currently working with the agency to determine how best to move forward. We are speaking with and working with each person on an individual basis and will be determining what options are available for each individual to receive their stem cells.    We are committed to sponsoring trials that are conducted under the auspices of federal and state agency requirements, and we remain enthusiastic and supportive of realizing the tremendous promise of regenerative medicine.  Thanks for your interest and support of regenerative medicine.  Thanks,   Madison  

The FDA means business and I think Celltex realizes that. They are making changes, which is good and I commend them for that.

It’s difficult to be sure exactly how this is going to play out and if Celltex will still argue its product is not a drug or if it has given up on that avenue.

I’m also still going through the warning letter and will provide more thoughts on it as well as the IRB warning letter in the future.