FDA visits both ICMS and reportedly Celltex: the scoop!

FDA stem cellsThe FDA has been busy with stem cell-related activities this spring.

Busier than publicly apparent.

Very busy, indeed!

Earlier, I reported that they issued a warning letter to cosmetician to the stars, Dr. LookGood, as well as one to another doc selling stem cell therapies.

Now it seems apparent that even more is going on behind the scenes. 

The International Cellular Medicine Society (ICMS) whose President, Dr. Ricardo Rodriguez, I interviewed a few weeks ago (see interview here), and to whom I provided recommendations here including a less adversarial relationship with the FDA, publicly announced that its IRB has been audited by the FDA.

What timing, huh?

According to the ICMS press release:

“We welcome the visit of the FDA.” says Ricardo Rodriguez, MD, president of the ICMS Board of Directors. “As a professional medical association, we share the FDA’s vision of enabling safe, effective cell-based therapies.”

I’m glad to see that ICMS issued a press release on the FDA visit.

The FDA also has been rumored to be on the move elsewhere.

Sources have told me that approximately 6 weeks ago, the FDA paid Celltex a visit.

The FDA visit reportedly lasted approximately two weeks.

Reportedly, Celltex is telling stem cell insiders that the outcome was positive with the FDA identifying only “minor” issues.

If true, that’s great news!

However, this could not be confirmed and to my knowledge the FDA has not issued any publicly available documents related to this visit. If the FDA found more than minor issues, one could expect based on precedent that a warning letter, which is a public document, should be forthcoming.

However, perhaps the FDA found nothing of concern and there will be no warning letter.

IMPORTANTLY, an FDA visit is not an indication that a company is doing anything wrong!

I emailed Celltex’s two founders several weeks ago offering to post a statement from them or answers to very fair questions on this blog. No response.

Earlier this week, I emailed them again, this time specifically asking for comment on the reported FDA visit to Celltex, which I offered to post verbatim.

No reply.

Recently I did a post encouraging Celltex to break their silence and engage the stem cell community.

One of the challenges that results from Celltex not interacting with the stem cell community, not having a website, etc. is that the media and scientists are left relatively in the dark.

As a result, scientists find themselves turning to the Internet, where they find patients putting up blog posts and comments on their supposed treatments by Celltex.

The patients are, as best as I can tell, uniformly enthusiastic to date.

One (see below) in her enthusiasm seemed to unambiguously indicate that Celltex was growing her stem cells in culture prior to giving them back to her as an autologous transplant.

If correct (and I don’t see how to verify one way or another if Celltex won’t engage in discussion), then this would seem to suggest that such a treatment is more than minimally manipulated according to FDA rules and hence subject to far more stringent vetting PRIOR to administration to patients.

Are the Celltex products more than minimally manipulated? I wouldn’t hazard a guess, but I am guessing that Celltex and the FDA have by this time discussed that critical question.

Blogger “mrscindy”, who according to her own account (again impossible to verify) is supposedly a CellTex patient, says amongst other things (emphasis mine, her last name is removed and replaced by XXXX’s by me):

GOOD NEWS!!!!! Yes, I’m shouting, shouting from the roof top! The stem cells have been banked! Yay!

I got the call yesterday morning from CellTex. When I answered the phone, I heard, “Mrs. XXXX? I’m sorry, I can’t talk because I’m smiling so big!” SHE’S smiling? Not nearly as much as I was! I had such a big smile I couldn’t say anything for a couple of seconds before I started shouting! The stem cells are banked and in two weeks we start the infusions! Yay!!! Can you tell I’m happy?

So……..what does this mean? It means my stem cell, which were extracted from my abdomen 10 weeks ago have been cleaned, processed and all damaged or degraded cells have been removed. These clean, strong cells are at CellTex and are now growing. I thought the growing was what took so long, but someone FINALLY explained that was just the processing portion. The growing, once the cells are clean and strong, takes only two weeks.

So appointments have been set up for the IV infusions. Each infusion will have 200,000,000 cells. The first appointment is June 19th, the second is June 26th, the third is July 3rd. Each appointment is set for 2:00 p.m., Texas time. All positive thoughts, wishes and prayers will be greatly appreciated on those days at that time. And when we celebrate July 4th this year, set off a few extra firecrackers for me!

There’s surely going to be more to these stories so stay tuned.

6 thoughts on “FDA visits both ICMS and reportedly Celltex: the scoop!”

  1. What are you treating with your stem cells? MS, Parkinson’s,etc. Please keep me informed with your progress. I have been contemplating this procedure to treat my MS. Best wishes to you.

    1. Hi Tom
      We r interested in brain disorders including MS.
      We r doing some preclinical studies in this area using iPS cells that r very exciting but not yet published. You r welcome to email me if you want to talk more about it or have questions. Thanks Paul knoepfler@ucdavis.edu

  2. Dallas Stem Cell Junkie

    Paul, I’m not sure about what went on at CellTex as it relates to the investigation. But be informed I do know what the FDA says about the post audit communication.
    Please refer to FDA’s “non-binding” recommendations for IRBs: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126555.pdf
    Specifically I point out that upon completion of the audit:
    1. A letter that generally states that FDA observed no significant deviations from the regulations. Note that a letter is not always sent when FDA observes no significant deviations.
    2. An informational or untitled letter that identifies deviations from statutes and regulations for which voluntary corrective action is sufficient. Occasionally, such letters request a response from the IRB.
    3. A Warning Letter that identifies serious deviations from applicable statutes and regulations. A Warning Letter generally requests prompt correction by the IRB and a formal written response to the Agency.

    Thx Junkie

    1. Thanks, Junkie. This is very useful. I’ve also been informed that any of the 3 options you mention can take months to materialize. Or no letter at all may appear.

      1. Dallas Stem Cell Junkie

        Hello Paul,
        I read what you said about post inspection activity, and I’m not surprised the reality of what happens in the field is very different from what is supposed to happen…from the FDA.”WHAT HAPPENS AFTER AN INSPECTION?
        At the end of an inspection, FDA personnel conduct an exit interview with responsible institutional and IRB representatives. At this interview, FDA personnel who conducted the inspection review and discuss the findings from the inspection and, if deficiencies are found, issue a written Form FDA 483″ My curiosity is whether the Completed Form 483 is available for folks like me to read?

        1. My understanding is that the FDA does not publish most 483s, but every now and then will put one up here:


          However, the 483s can be requested and obtained by members of the public.

          I have never done this so I do not know (A) the mechanism and (B) how complicated it is.

          I believe that some interested 3rd parties regularly do ask the FDA for 483s regarding certain clinics.

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