I’m not sure. We may find out tomorrow as the FDA updates their public warning letter list early in the week.
Celltex is that famous stem cell company in Sugarland, Texas that gave Guv Rick Perry stem cell transplants. It was inspected by the FDA in April. The FDA found numerous issues with Celltex and called the company a “drug manufacturer”.
In the interim, Celltex has responded to the FDA publicly and privately in a number of ways, but always making the consistent argument that its stem cell product, which it grows in culture prior to it being put into patients, is NOT a drug. It has even said it has “shown” the FDA this to be true.
However, today Celltex released a press release (PR) saying it has received a “letter” from the FDA that seems to indicate Celltex has not convinced the FDA despite responding to the FDA, according to the PR in “April, May, June, July, and August”. Wow. The word “warning” does not appear in the PR.
Reportedly, the FDA letter stated:
the agency’s opinion that the process Celltex uses to multiply adult stem cells is subject to FDA regulation as biological drug manufacturing.
It sure seems the FDA is convinced that the Celltex product is a drug, huh?
CEO David Eller responded:
Celltex makes identical copies of an individual’s own stem cells and therefore should not be subject to FDA regulation as drugs. However, the FDA said our process causes the cells to be considered biological drugs and thus is subject to those regulations. We respectfully but firmly disagree with the FDA and intend to contest the agency’s opinion within its administrative procedures. We are considering all options as we work with the agency toward a resolution.
Of course anyone who has grown cells in culture as I have for about 2 decades, knows that cells do not in fact make identical copies of themselves in a plastic dish in an incubator in a lab. That environment in fact favors the growth of cells that are more cancer-like in a general sense because they outcompete other cells in the harsh, artificial environment of a lab. This is one of the FDA’s big concerns.
Other news in the Celltex PR was that:
Celltex is preparing Investigational New Drug (IND) clinical trials focused on the effectiveness of adult autologous stem cells for specific conditions, such as multiple sclerosis, osteoarthritis and macular degeneration.
So Celltex is going to do an IND! What about a BLA? Was the FDA letter a warning letter or just a “letter”?
Stay tuned to this developing story.