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.
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 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.
“it may be good for people to remember why we have phases in clinical trials
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.
Phase 1: Screening for safety
Phase 2: Establishing the testing protocol
Phase 3: Final testing
Phase 4: Postapproval studies
Each phase has a different purpose and helps scientists answer a different question:
In Phase 1 trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the experimental treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
In Phase 4 trials, postmarketing studies delineate additional information, including the treatment’s risks, benefits, and optimal use.
Before pharmaceutical companies start clinical trials on a drug, they conduct extensive preclinical studies.
Very nicely summarized Amy. I think this needs to be cut and pasted into a number of discussion groups related to this subject.
Centeno brokered a deal with his legal team; A stake in the company to off set legal fees and poof! A new VP. Additional evidence of this gasping breath is Centeno blaming the FDA for tourism in this illuminating interview with the David Prentice/Koch Brothers backed LifeNews. In my opinion, and many others, a blatant disregard for life and the irrelevance of Celltex
http://www.lifenews.com/2012/08/01/why-dont-patients-stay-in-the-u-s-for-stem-cell-treatments/
Mary, I’m not sure I understand the link you suggest in your comment between Centeno and Celltex?