More Celltex Q&A: we are not a drug manufacturer

I’m enjoying Celltex’s new website and I’m appreciative of their great responsiveness to my questions. Transparency is a beautiful thing!

My latest question to them was whether they, given that the FDA called them a “drug manufacturer”, are now planning to or have already filed an IND.

An IND is an application for an investigational new drug. It is an essential early step for companies seeking to advance a new drug into clinical trials.

Here was the response from Celltex:

Dear Dr. Knoepfler,  

In your recent inquiry on our website, you asked: “After the FDA audit and what I assume is still an ongoing dialogue between Celltex and FDA, are you now gearing up to file an IND with the FDA? I mention this because the FDA specifically described Celltex in the 483 audit report as a “Drug Manufacturer””.  Our response is as follows:  Yes, Your characterization of an “on-going dialog” is correct.  Our relationship with the agency has been very positive. We speak with them regularly in addition to written communications.    Celltex invited the FDA to inspect our facility and the FDA did  inspect our lab in April of this year.  The inspector stated on the 483 the “type of establishment” was a “biological drug manufacturer.”  Since then we have shown the agency that we are, in fact, an “HCT/P” (human cells, tissues and tissue and cellular products) facility.      Our current laboratory provides autologous mesenchymal stem cells banking and expansion services which are HCT/Ps.  As you surely understand, we will not comment at this time on future products in development.   We are adding additional information to our website ( that will explain the legal environment in further detail.  We expect to have that available within the next couple of weeks.  Thank you for your continued interest. 

Sincerely,  The Celltex Team  

A big “thank you” to Celltex for the detailed answer. I find it fascinating.

It seems to me that Celltex is asserting in this response that they have shown the FDA that they are in fact NOT a drug manufacturer, but rather an HCT/P facility.

Is the FDA convinced?

Celltex may have “shown” the FDA something, but that’s not the same thing as having changed the FDA’s mind. I guess we’ll see.

Past cases such as with Regenerative Sciences Inc. would seems instructive that the FDA views cell growth (what Celltex calls “expansion” or “multiplication”) as automatically defining a cellular product as a drug. The recent federal court ruling gives the FDA strong legal backing to take this regulatory stance.

Then there’s this FDA guidance that would also seem to strongly suggest that the Celltex mesenchymal product is a drug.

Particularly notable is the passage below (emphasis mine):

  • Somatic Cell Therapy Products: Most other cell therapy products that are not specifically indicated on the main listing menu or the drop down menu should be listed as Somatic Cell Therapy Products. Examples of Somatic Cell Therapy Products include but are not limited to: hepatocytes, myocytes, fibroblasts, dendritic cells, mesenchymal cells, adipose stem cells. allogeneic pancreatic islet cells and certain bone marrow cells that have been more than minimally manipulated as described above.
    • FDA currently views, for the most part, that somatic cell therapy products include the cell therapies as explained in the Federal Register Notice (Vol. 58 No 197, 10/14/1993, p53248), “Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products”. These cell therapies do not fit the 21 CFR Part 1271.10 criteria for regulation solely under section 361 of the PHS Act and are regulated as biological products subject to pre-market review and licensure. Human somatic cell therapy products include autologous or allogeneic cells that have been propagated, expanded, pharmacologically treated, or otherwise altered in biological characteristics ex vivo to be administered to humans and applicable to the prevention, treatment, cure, diagnosis, or mitigation of disease or injuries.
To me this sure suggests that the FDA would think that Celltex has a 351 stem cell drug on its hands, not a 361 type of biologic as Celltex contends. In the end, the FDA will make this determination, but the tea leaves do not look promising for Celltex.

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