LA Times Shines Some Light on Stem Cell Clinics including StemGenex

A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example.StemGenex

He started off with a description of the kind of hopeful feeling that many patients experience upon visiting stem cell clinic websites:

“Visitors to the website of StemGenex, a La Jolla medical group, could be forgiven for thinking that the answer to their prayers is finally at hand.”

However, there is little published data to support the expectation that one’s prayers might be answered at U.S. stem cell clinics today. I talked with Hiltzik about the state of the American stem cell clinic arena and my concerns as he was researching his piece. The marketing of stem cells is too aspirational in my view and patients are sold medical interventions in many cases that may not work and have potential risks. Hiltzik writes (emphasis mine):

“StemGenex’s director of media and community relations, Jamie Schubert, told me that its “principal purpose is helping people with unmet clinical needs achieve optimum health and better quality of life,” and that it has “anecdotal feedback … from our patients that their symptoms have dramatically improved and their quality of life has substantially increased.”

Keep in mind that we are talking about hundreds of clinics in the U.S. injecting living stem cells into patients’ bloodstreams or into specific tissues and most clinics out there do not have FDA approval to do this so anecdotes are not a strong foundation for this kind of practice in my opinion.

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Content Wiped on Websites of Stem Cell Clinics Warned by FDA

Irvine Stem Cell Treatment CenterA couple of months back, the FDA issued a warning letter to three co-owned stem cell clinics selling fat stem cell-based interventions to patients for a variety of ills.

You can read all about the warning letter here. It went to lead clinic, Irvine Stem Cell Treatment Center as well as the two co-owned clinics, which are Manhattan Regenerative Medicine and Miami Stem Cell Center. Dr. Thomas Gionis was the person to whom the letter was addressed.

Irvine seems to have taken down its website content in the last week or two (see image above). The same is the case at Manhattan Regenerative Medicine, while Miami Stem Cell Center’s page remains up as of now. To me this suggests some change is in the air.

Many questions have been raised by the FDA warning letter including why this particular set of three clinics were warned, when others seemingly doing just about the exact same thing have not been warned, at least that we know of so far.

Stay tuned for more on Irvine and Miami Stem Cell Centers probably in the next week or so.

FDA warning points to tougher regulation of fat stem cells & clinics

FDA logoLast week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US.

What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells?

The FDA is still in the process of getting public comment and finalizing draft guidelines related to stem cell clinical products including fat stem cells aka adipose stem cells and stromal vascular fraction or SVF.

Even so, the FDA just issued this new warning letter at least partially related to SVF to a series of co-owned clinics in CA, FL and NY here in the US going under the names Irvine Stem Cell Treatment Center, Miami Stem Cell Treatment Center, and Manhattan Regenerative Medicine Medical Group.

In the letter the FDA explicitly calls SVF a biological drug in this context and mentions that there’s no IND and no BLA (for more on these key acronyms see here) at the clinics.

As discussed in the comments on my first post on this warning letter, the FDA language is a bit puzzling in the language used in the part calling the SVF a drug. The letter first mentions several target conditions as an implied possible reason for the definition as a drug and then only later indirectly mentions more than minimal manipulation as possibly involved. Non-homologous use is also mentioned. Overall this letter is not very clear. A helpful FDA reform would be a commitment to clear writing in its public communication.

Still the relatively unambiguous wording in the letter calling SVF a drug here is striking given that the FDA again has not to my knowledge finalized its guidance on SVF. It’s hard not to read the letter as meaning the FDA has every intention of defining SVF as a drug in many if not all cases.

This is a big deal because scores of stem cell clinics in the US are injecting SVF into patients on a daily basis without any FDA approval, licensing, etc. It’s not clear why these three co-owned clinics got the first FDA warning letter in the last few years on stem cells when there are all these other clinics doing very much the same thing. That’s also puzzling and leaves an important open question. More broadly as far as I know there’s no public information on how the FDA assesses which entities to focus its limited resources upon at any one given time.

What does this mean for all those other fat stem cell clinics out there? It’s bad news for them as the FDA could and really should be taking a close look at them too. The FDA is slow at times to take action as I’ve been critical of them about in the past, but once they get going, those not following the rules have reason to be concerned.

What about those recent still only draft FDA guidances (e.g. see a nice piece by Alexey on the situation with fat stem cells here)? I suppose they could change or take a long time to be finalized, but this warning letter can be viewed as a strong signal that the guidances are unlikely to change in their core points.

One of the largest collective users of SVF in the stem cell clinic world is Cell Surgical Network (CSN), with whom Irvine was previously affiliated. I contacted CSN more than a week ago by email for comment on the warning letter and to get their perspective on this development, but have not received a reply. To my knowledge, CSN has not been subject directly to FDA action, but I do not know when the apparent split with the Irvine clinics occurred.

Until more information about what the FDA is doing & thinking (at least as expressed by their written words) hits the  public domain, the key puzzles mentioned above will remain open for speculation. However, this letter possibly signals a major turning point for regulation of clinical use of adipose stem cells, particularly in the clinic realm.

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.

My new ‘neighbor’ in Sacramento: a fat stem cell clinic

Thomas A. GionisFor years I’ve been writing about stem cell clinics that sell non-FDA approved stem cell “treatments” to vulnerable patients right here in America.

These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in a locale near me.

Tomorrow, July 11, reportedly the Irvine Stem Cell Treatment Center will open a Sacramento, CA branch. The doctor there will apparently be Thomas A. Gionis (picture from press release). This private, for-profit clinic has no affiliation with UC Davis School of Medicine in Sacramento where I’m located.

The stem cell clinic Sacramento branch will sell transplants of fat stem cells in the form of something called stromal vascular fraction or SVF, which I believe is almost certainly a drug. To my knowledge this clinic and the large chain that it belongs to called Cell Surgical Network (CSN), do not have FDA approval to use SVF.

Both publicly and to me on this blog, CSN continues to argue that it doesn’t need FDA approval (herehere and here), but recent FDA draft guidances sure suggest otherwise in my view. Of course if the FDA never takes action on the use of SVF then how are we all supposed to interpret that? Without FDA action or finalized guidelines, is it formally possible that the FDA could back down on SVF?

This clinic will reportedly sell SVF to treat a dizzying array of conditions having nothing to do with fat:

“Emphysema, COPD, Asthma, Heart Failure, Heart Attack, Parkinson’s Disease, Stroke, Traumatic Brain Injury, Lou Gehrig’s Disease, Multiple Sclerosis, Lupus, Rheumatoid Arthritis, Crohn’s Disease, Muscular Dystrophy, Inflammatory Myopathies, and Degenerative Orthopedic Joint Conditions (Knee, Shoulder, Hip, Spine).”

To me as a scientist the use of SVF to treat all these very different conditions does not make good common sense.

It would also seem arguably to be quite likely be considered “non-homologous use” by the FDA, a standing that would also automatically make this a drug requiring FDA pre-approval. Non-homologous use means using a biological product of a certain kind that is not homologous (not the same or similar in origin) to the tissue being treated. For example, fat is not the same as the brain or other central nervous system tissue that is involved in several of the conditions on the clinic menu. Same goes for cardiac muscle, airways, etc.

The use of a non-FDA approved product in a largely non-homologous manner increases risks for patients. Note that these stem cell transplants are also very expensive with little evidence in the way of published data of benefit.

The CSN stem cell clinic in Sacramento will be located at the New Body MD Surgical Center, just about 10 minutes from my office. I plan on paying them a visit at some point. Let’s see how that goes. Will they let me in?