Celltex FDA FOIA letter #2: no safety concerns with our stem cells, which really are not drugs

A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed  letters from Celltex  to the FDA that previously were not in the public domain.

The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I have tried to continue a dialogue that I started with the company in 2012, but they have stopped communicating. From a pragmatic perspective, I suppose I can see why they may have decided to take this approach, but there are important issues remaining that bear on patient safety and the stem cell field so more analysis and openness is needed.

In the first post in this series I discussed the background to getting this info and some key points of Celltex’s history.

In the second post I went through a brief letter from Celltex council to the FDA in reaction to Leigh Turner’s letter to the FDA.

Today our focus is on another Celltex letter, this one dated April 27, 2012, to the FDA in which they argue in detail why they believe their stem cell product is not a drug.

In the upcoming fourth post I will publish and discuss a letter from May 2012 from Celltex to the FDA that I think is particularly important and suggests new events that raise crucial new questions. Stay tuned.

To my knowledge no one but the FDA and Celltex have ever seen these May and April 2012 letters before.

It is also worth noting again that Celltex claimed that all of these letters were exempt from the FOIA law.

What’s in this April 27th letter from Celltex to the FDA?

You can read it here for yourself: CellTex FDA Letter 042712.

However, since it’s 10 pages long, I will summarize it for you below.

The overall point is that Celltex argued repeatedly in the letter that its stem cell product was not a 351 biological drug and that it itself was not a biological drug manufacturer.

In addition, Celltex says over and over (see just one sample portion of the letter above at the top of this post highlighted by me with red circles) that their product raises no safety concerns.

Many of their arguments in this letter cite for support a single paper from RNL Bio, their partner at the time but not longer. As a stem cell scientist, I’m not a particular fan of that paper.

My view is that Celltex relied far too much on RNL Bio more broadly and in the end that reliance has been a crucial problem for Celltex.

Celltex may be fortunate to no longer have RNL as a partner, but they are still bound together in some ways including, as best as we know, that RNL still possesses the Celltex patient samples. As we have all seen RNL Bio’s leader, Jeong Chan Ra, was recently arrested for insider trading and faces other issues.

Getting back to the April 27, 2012 letter released by FOIA, in my opinion Celltex makes the following assertions  and next to each bullet point is my reaction in unbolded text, which simply again reflects my own view on things and could be wrong:

1. Celltex products (AdMSCs) are strictly 361 HCT/Ps. They are not drugs. My reaction–growth in culture clearly makes stem cells a 351 drug. Even if one assumes that Celltex felt there was some ambiguity on this last spring, it seems unlikely that their strategy of simply stating their product was a 361 would prevail with the FDA even at that time.
2. Celltex AdMSCs are for homologous use only. Homologous use is a complicated issue, but I disagree with Celltex’s opinion on this. Adipose-derived MSCs (AdMSCs) are from fat and the clinical applications of Celltex’s AdMSCs was not to treat strictly fat-related diseases or injuries, but rather other conditions including MS (a neurological disorder), a disease whose pathobiology to my knowledge does not naturally involve MSCs.
3. Celltex’s products are not more than minimally manipulated. My reaction-–again, growth in culture and removing the MSCs from fat using collagenase is more than minimal manipulation according to the FDA.
4. Celltex’s stem cells are only combined with storage agents, media, and saline. Note that here in their letter there is a Celltex footnote on page 3 indicating that, to the contrary of their sentence, the stem cells most probably (there is redaction here that makes things challenging) are separated from fat tissue via a Stromal Vascular Fraction (SVF)-like procedure, which involves collagenase.
5. There are no clinical safety concerns concerning the AdMSCs that undergo Celltex’s services. Celltex says this many times in the letter. That is a gross oversimplification in my opinion. There is not such thing as “no safety concerns” with a stem cell product that is intended for transplantation.
6. Under a subheading “Conclusion”, “Celltex is in compliance with applicable federal law”. The FDA seemed to disagree.

In the end, given the FDA warning letter to Celltex that followed, it is clear these arguments did not convince the FDA. As I reported earlier, the FDA investigation of Celltex continues.

My feeling overall is that this letter reflects a somewhat overly optimistic, argumentative viewpoint.

Stay tuned for part #4 of this series where I discuss the longer and I think crucial May 2012 letter from Celltex to the FDA.