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 (here, here 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.
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.
I think this is the same situation when Intelli BioSciences got their warning
@Paul – you’re quite right, the FDA raised several concerns all in one letter so it’s not easy to delineate how the hierarchy of decision-making in the FDA works (was it ever?)
You’re also correct that switching to a “cosmetic intent” would greatly reduce the addressable market. But it also reduces any need for showing efficacy and safety. Basically, you escape and due diligence by the FDA – and save money. It’s a business model.
In Germany it’s still legal to practice “fresh cell therapy” – direct intramuscular implantation of live cells or extracts from donor ANIMALS! (sheep, horse, etc). On their websites (e.g. http://www.villa-medica.com), companies offer treatment for arthritis, pain, cardiac and liver disease, diabetes mellitus, autism, cerebral palsy and MS. This doesn’t look too different to non-approved stem cell companies – potentially very dangerous and all you need is GMP.
@admin
If you are curious, you should find out for yourself. If you think they are not prospering, can YOU support that claim ?? NO. You prefer sitting in your office chair, imagining stuff up and typing out generalities without going out in the street to know the truth or any intention to tell the truth.
It is not like private clinics who do this are NOT expecting FDA warning letters and suddenly wake up one day and are shocked to see one. Is not pathetic that out of so many clinics that are doing this right here in US here, one clinic gets a letter. The point is, as you repeatedly fail to understand, is not what it means to one clinic, but FDA actions fail to alter the course, perhaps more geared to their own promotions and resume.
Are you worried about whether I am at odds with my sister’s views?? I have been arguing the same things with your views and why would you think I would argue any differently?? Perhaps academicians like you can talk out of both sides of their mouth to advance themselves. We pursue truth and the treatments that make a difference to us.
So, would a genetically modified human be a drug?
@Brian,
From what I’ve heard the answer is most likely “yes” according to the FDA. But I”m guessing some would dispute that.
By the FDA doing this sort of thing it will only make the situation worse for clients. Clients will all just go to clinics in locations where the FDA has no control or power. This will give greater growth to money hungry clinics with much poorer quality of treatment. Better to have had some control rather than push everyone out of countries where clinics do take an interest in clients health and outcome. It is the people who keep shouting about wanting more FDA control that is causing this to happen. Better for researches and clinics to work together than split it between a them and us situation. I personally are having problems getting the treatment I want because of all the rules and regulations and this will only make it worse. THANKS FDA!!!!!
@David,
I see your concern, but at the same time the FDA cannot fail to enforce its regs just because such action might encourage some entities to move outside of its sphere or we’d have no regulation. It’s difficult to know which clinics you refer to as “money hungry” and how one can differentiate those from the clinics not interested in making a profit, if there are any such. I’ve never heard of a clinic treating patients at cost.
I’m confused about the definition of a drug – I’m not referring to the, “more than minimal manipulation” of cells that differentiates transplants from drugs, but to the “intention for use”. For example, in the letter the FDA states:
“Your SVF product is intended to treat a variety of diseases and conditions…and is therefore a drug under section 201(g)…”
Does this mean that if the clinic suggests an identical procedure, but now for something not therapeutic (such as wellness, rejuvenation or similar “cosmetic” statements), the procedure will be allowed? Or does it just mean the FDA no longer have jurisdiction?
In the case of Lancome’s Genifique, the FDA pulled them over due to the fact they were marketing creams with therapeutic claims – but if not for alopecia, the cream can be sold as a “rejuvenation” product, like all the others.
So could a non-approved stem cell clinic also fly under the radar as a cosmetics company?
@Gary,
I think there are 2 things going on here at least. First, FDA says non-homologous use of SVF for many non-adipose related conditions. Second, and this requires a bit more reading the tea leaves, possibly an FDA perspective of more than minimal manipulation based on this phrase in the letter “Please be advised that processing by various means (e.g., (b)(4)) that alters the original relevant characteristics of the structural tissue relating to the tissue’s utility for reconstruction, repair, or replacement generally would be considered more than minimal manipulation.” and also the strong wording of the FDA draft guidance citing SVF as an example of more than minimal manipulation. It’s interesting that the FDA took a strong stand here on SVF given that the guidances are still not finalized. I expect that could be a source of contention from those who do not see SVF as a drug. However, the FDA raised a number of additional concerns all rolled into one Warning Letter.
As to your other question on switching to a cosmetic intent, frankly I’m not sure and perhaps it depends on context. That would also have a much smaller market than saying we can treat XYZ, etc etc. via translants so that’s a consideration that also relates to your last question.
Well…Celltex survived and is flourishing, didnt it? Looks like FDA warning letters are not that big of a deal anymore and probably should be printed in the future on a high-absorbent toilet paper, if it is any worth. It is more likely that FDA is playing to the JV stands where folks like you jump up and down and clap with joy. The big boys of stem cells be it Celltex, Stemedica, Okyanos or where ever have charted their own path. My kid sister is a researcher and she thinks this ‘action’ is too little and inconsequential, almost childish in the broader picture, and probably will bring Ms. Malarkey much worth to her name.
@ALSadvocate,
Is Celltex “flourishing” in Mexico and is now a “big boy” of stem cells? I’d be curious to hear more about that claim.
An FDA warning letter is a big deal no matter what you say your kid sister thinks. Just ask Irvine Stem Cell Treatment Center if they view it as something inconsequential at this point with only a few days before their deadline to address the FDA’s list of concerns.
If your sister wants stronger action from the FDA, doesn’t that put her at odds with you based on your past comments?