October 27, 2020

The Niche

Knoepfler lab stem cell blog

New Celltex website goes live for the first time, making many safety & efficacy claims

Celltex, the controversial stem cell clinic in Texas, announced in a press release (PR) today a couple of new hires. It also fired up its website for the first time that I am aware of.

You can check out the website here. Wow.

The website is notable since it has been inactive for quite some time.

I am curious what prompted the company to now have a website? I think it is great as it provides a window into the company.

For example, describing their technology, they for the first time publicly discuss their isolation and multiplication technology on this page:

Cells must first be isolated and separated from the fat tissue. Celltex’s process uses fat tissue as its primary source because of the consistency of the cells in each sample. (Find out more about why we use fat.) Our process involves the careful separation of just the Mesenchymal Stem Cells (MSCs) from a very small fat tissue sample – small enough to be minimally invasive for any donor. The newly separated MSCs undergo our Passaged Culture process that can multiply exponentially the separated cells into millions and millions of identical copies.

It’s unclear, of course, that after multiplication that the cells are in fact identical copies of each other, which is why the FDA is so concerned about cell growth prior to transplant.

For a screenshot of the Celltex homepage see below.

Celltex

Celltex also now has a contact page here, which I already used to ask them the question “What growth factors are used to multiply the stem cells?”

The Celltex management team can also be seen here.

The website also greatly touts the efficacy of Celltex stem cells to potentially be used for many diseases and describes their product as “rigorously” safety tested, citing a Stem Cells and Development paper, which turns out to be an RNL Bio paper including no authors from the leadership team of Celltex. The paper suggests safety on the RNL product, but is not conclusive in my opinion. RNL Bio has, according to Celltex itself, been running the Celltex Texas clinic.

RNL Bio has also been, independent of its relationship with Celltex, sued for fraud recently related to use of its stem cell technology.

I’ll be curious to see what you all think of Celltex’s website and the claims they make on it.

They also issued a PR today.

According to the PR, Celltex has appointed:

Andrea Ferrenz, Executive Vice President, Legal Counsel, and Jane Shen Young, Manufacturing Research Scientist

This move is seen in the stem cell field at least in part as a response to an FDA audit of Celltex in April.

Celltex CEO, David Eller, was quoted that:

“At Celltex, we firmly believe in the great therapeutic potential for adult stem cells and we are committed to the highest quality banking and multiplication services for clients and physicians.”

The multiplication services (emphasis mine in the above quote) of Celltex were used most famously to supersize a stem cell treatment given to Texas Governor Rick Perry, who I met with in June to discuss stem cell policy, but the cell growth is, as mentioned above, also what many experts see as a potentially particularly troubling regulatory sticking point for the FDA with Celltex.

Some experts such as Lee Buckler view cell growth unambiguously as “more than minimal manipulation. You can read my interview with Lee here where he was refreshingly frank about all this. It’s very concise and educational.

On this blog I first mentioned Ferrenz’s hiring in an early July post as legal counsel related to a Celltex SEC filing. Also hired at that time was a new QA manager, Jonathan Cisneros.

Young, a physician scientist from China with an MD/PhD (PhD from Lund University in Sweden) was quoted as follows:

“Quality and safety are tantamount to the growth of this industry and I am excited to help Celltex provide stem cell banking and multiplication of the highest quality to its clients.”

The PR says that Young “has expertise in cell biology, molecular genetics and biochemistry. She has also co-authored publications on the development and optimization of laboratory assays, and cell sort and flow cytometry analysis.” In a simple Pubmed search I was unable to find any publications for her, however sometimes Pubmed misses authors. I’d be interested to read Young’s publications if anyone can help me find them.

The PR and website are possible responses to the FDA inspection, but may also reflect growth of the company even as it works to find its way in the ever-growing complexity of the stem cell universe.

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