May 30, 2020

The Niche

Knoepfler lab stem cell blog

FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US

The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions.

At one time this clinic was part of the larger Cell Surgical Network (CSN) chain of clinics, but it seems it is no longer listed on the CSN website. You can see, however, that Gionis and Irvine are listed on this archived page from the CSN website.

Both publicly and on this blog, CSN in the past argued that it doesn’t need FDA approval for its stem cell product or its use (herehere and here), but recent FDA draft guidances imply otherwise in my opinion. Note that this new Warning Letter does not mention CSN.

You can see a screenshot of the top of the Warning Letter below.

This is post number one in a series on the breaking news on this development.

Gionis Irvine FDA Warning Letter

A Warning Letter is a serious form of FDA action. For instance, the Texas stem cell clinic Celltex received one and later moved its clinical operations to Mexico in part as a result. It’s unclear at this time what impact if any the Warning Letter will have on Irvine Stem Cell Treatment Center (note that it has multiple locations in NY, CA, and FL, each mentioned in the letter), but it’s definitely bad news for the clinics in my view.

The Letter outlines three major areas of problems:

  • (1) the adipose stem cell product being used (stromal vascular fraction or SVF)  is an unapproved biological drug
  • (2) non-homologous use of the product
  • (3) more than a dozen specific problems related to the production of the stem cell product SVF at the Irvine facility that the FDA termed, “a number of significant objectionable conditions”.

All three general areas of issues are serious.

The first two problems related to the FDA defining the SVF as a drug product and its use in what the FDA calls a nonhomologous fashion probably will have the broadest impact across the US. More than one hundred clinics use SVF in the US without having any FDA approval or licensing, and they use it in similar ways to Irvine that are likely to be deemed nonhomologous use as well.

As a result, this Warning Letter should be a wakeup call to these clinics. Despite the quietness of the FDA in the last two years on stem cell clinics, this could indicate a period of greater activity has begun.

The section defining the SVF as a drug in the letter is this one, emphasis mine:

“Your SVF product is intended to treat a variety of diseases and conditions, including, but not limited to, autism, Parkinson’s disease, pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), cerebral palsy, and amyotrophic lateral sclerosis (ALS), and is therefore a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)]. It is also a human cell, tissue, or cellular and tissue­based product (HCT/P) as defined in 21 CFR 1271.3(d).”

The relevant section on non-homologous use:

“In addition, your SVF product fails to meet 21 CFR 1271.10(a)(2)’s criterion that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.”

The other dozen or so issues with the production and the facility practices of Irvine Stem Cell Treatment Center are quite significant as well in my view and include sterility practices.

The FDA inspected several Irvine Center clinic locations, but apparently not the one that seemed to kinda pop up last year in my neighborhood here in Sacramento. I’m not sure if this local one exists currently.

Irvine has responded to some ongoing issues raised related to the series of inspections, but not sufficiently says the FDA. Notably, the section on responses included this partially redacted phrase:

“you have terminated your relationship with the (b)(4)“.

I wonder if this refers to CSN? Hard to know.

Even though this Warning Letter does not mention CSN, the issues raised therein are in my view likely to be at least somewhat of interest to active CSN clinics too. I’m planning to contact CSN leadership to ask for a reaction to the letter and clarify whether CSN and Irvine are indeed no longer affiliated as would seem to be the case.

Irvine has only a few more days left of the 15 day response period to address the concerns raised by the FDA.

Stay tuned for more on this breaking news in follow up posts. This is a long Warning Letter with much to think about in it.

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