Predictions heat up on FDA audit of Celltex

Celltex is an adult stem cell company in the great state of Texas that reportedly has produced adult stem cell products used for the treatment of more than 100 patients with stem cells. We don’t know much about Celltex (e.g. it has no website), but I was hoping to change that in part via a friendly invitation to Celltex co-founders David Eller and Stan Jones to do an interview or post a piece written by them verbatim on this blog as I have done with ICMS and others.

I got no response from Celltex.

Celltex has also been at the center of significant controversy relating to a conflict between it and the University of Minnesota over issues of ethics and practices.

University of Minnesota professor Dr. Leigh Turner wrote the FDA asking it to take a look at Celltex. The Houston Chronicle quoted Celltex co-founder David Eller at the time that he is confident that Celltex will “meet all FDA specifications.” and the article went on to say that Eller “emphasized that Celltex doesn’t administer stem cells, but stores and processes them at the behest of doctors who later re­inject them into patients”. In the same article it is discussed how the Texas Medical Board (TMB), at the encouragement of Texas Governor Rick Perry’s administration, has weakened regulations for adult stem cell therapies.

I broke the news here on this blog a few weeks ago that the FDA had conducted an audit of Celltex sometime in April. Whether of its own plan or at the urging of Dr. Turner, the FDA reportedly “visited” Celltex for two weeks. Folks I know in the biotech industry say that such a visit is a very intense and never welcomed experience…as one insider said it is “like to a two-week-long, nonstop root canal.”

What did the FDA find at Celltex?

At this point we still don’t know, but speculation is heating up.

Mario Salinas of the great organization Texans for Stem Cell Research predicted in a comment on this blog:

Celltex will be in compliance with cGMP rules. What may be more concerning will be the IRB oversight of “practice of medicine exempt from FDA.” This is the realm of physicians operating under the new TMB rules. Now the stakes go up. If the FDA has a problem with this (and I suspect so), we will probably see the State of Texas take this to court and we will be in a huge legal battle that will shut down the new approach for a long time.

Is Mario right?

We don’t know yet, but the stem cell grapevine generally seems to concur with most of Mario’s views.

Will the FDA largely “green light” Celltex?

Or will the FDA find serious problems with Celltex?

Either result will be fascinating and have major impact.

For example, if the FDA essentially OKs how Celltex has been operating, many in the stem cell field will view it as a turning point opening the door to far less regulation of adult stem cells, however such an outcome would seem at odds with years of precedent of how the FDA views things.

Alternatively, if the FDA as Mario put it “has a problem” with certain important aspects of Celltex’s practices, then this too will be fascinating because it will suggest a future of continued regulation. Many insiders seem to agree with Mario that such an outcome may lead to a legal battle between Texas (as directed by the Texas Attorney General via Governor Perry) and the FDA.

I believe that we can balance somewhat faster FDA vetting with safety, but it will take biotechs working with the FDA not against. For example, if as reported Celltex has indeed produced stem cell products that have been used to treat 100 patients without in advance consulting with the FDA, I personally am of the opinion that that will in the long-term turn out to be counterproductive.

I care a great deal about these issues as both a stem cell scientist and patient advocate. I myself met with Governor Perry two weeks ago today as I discussed here to talk about advancing stem cell research. I found the meeting encouraging and hope that we will follow it up with a 2nd meeting in Texas later this year to discuss the future of stem cell-based medicines.

In an earlier blog post about a month ago I wrote an open letter to Perry indicating 5 ways that I thought he and Texas could be lead the way on stem cells. Notably, #4 on that list was advising him to put some distance himself from Celltex precisely because the stem cell field was “reading the tea leaves” that an audit was coming if it had not indeed already happened. If the FDA audit did not go well for Celltex, one can imagine future newspaper headlines on that topic to prominently mention Governor Perry, an outcome I thought would not be in his best interest.

We in the stem cell field don’t know yet the outcome of the FDA audit, but soon enough the facts will become known whether it is in 5 minutes or 5 months from now.