Polls on futures of stem cell clinics sued by FDA

i voted sticker

i voted stickerTake our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019?

To be clear, I am asking for your predictions, not what you hope will be the situation a year from now.

U.S. Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center along with its parent stem cell clinic chain Cell Surgical Network were separately but in parallel sued in May by the FDA via the DOJ seeking permanent injunctions on what the FDA has indicated are non-compliant practices using unapproved stem cell drug products.

To my knowledge, these firms continue to sell the stem cells in question, which are adipose stem cell injections sometimes referred to as “stromal vascular fraction”. I also haven’t seen any indication that the firms are going to voluntarily stop what they are doing or that the FDA is aiming for a temporary injunction. Things have been awfully quiet on this front, at least in the public domain.

With this context in mind for today’s 3 polls, one year from today, what will be the status of these firms? Do they face similar outcomes? Will anything be different in October 2019 versus today? Will there be impact on California Stem Cell Treatment Center but not the whole big network that it leads? No change at all? What about USRM?

You can also weigh in on the polls or these situations in the comments.

11 Comments


  1. I’d love your take on The American Academy of Stem Cell Physicians at some point. It looks legitimate on the surface, but what I read and who attends seems to be some of the above… for-profit, unproven stem-cell treatments.

    http://www.aaoscp.com/


  2. FDA’s issues with SVF is primarily, at this point, a definition. It is a 351 or 361 categorization issue, which in my opinion, is a ludicrous issue. Manipulating the cells via enzymatic processing, does not, in my opinion, elevate those cells to a ‘drug’ status. Nor, do I believe expansion elevates it to a ‘drug’ level. In neither case do you ‘change’ them in any way. You remove a portion of the tissue which is ‘unwanted’. Similar to removing fat from a vein graft. I just don’t believe they become a ‘drug’ in any way. This is not to say they are used legitimately nor efficaciously. Just that they should not change status.

    However, I do believe that the FDA has a role in insuring ‘truth in advertising’ as well as standards of processing care, ie, basically insuring the processing of the adipose tissue is done in a safe manner, both from and infections/contamination point of view as well as insuring the chemicals utilized in the process meet safety and efficacy standards.


    • @Shane,
      Exposure of cells to enzymatic treatment can dramatically change them. For instance, cleavage of extracellular domains of membrane proteins on the cell surface can strongly alter signal transduction. I saw a talk on this many years ago re: trypsin. Enzymatic treatment also stresses cells, killing some and leading to enrichment for others that survive. Do these things happen with the heterogeneous pool of cells in fat tissue during production of SVF? It seems very likely. The other issue you didn’t mention is non-homologous use, which can also make something classified as a drug product. I can see logic in the idea that putting something like fat cells into a totally unrelated tissue like eye raises risks.


    • I think it’s ludicrous to ignore science. Enzymatic digestion does alter cells, in unpredictable ways. Culturing the surviving cells alters them further. Putting fat cells into the bloodstream makes no biological sense. Putting fat cells into fat does make sense, but who would pay for that?
      Please let me (and the FDA) know when there are release criteria that show that the product is consistent and safe. Scientific assays are available and do not rely on belief in magic or faith (genome sequencing, SNP genotyping; flow cytometry, immunocytochemistry, viability assessment, gene expression profiling; functional assays). One of these networks could use their profits to set up a CLIA lab to test all of these things for their clinics.


  3. I went to lung institute recommended by a Kaiser nurse,i would not recommend it to anyone,i would say more but im involved in a class action against them


  4. Sure. Enzymatic digestion alters these stem cells how, Dr. Loring? In unpredictable ways? That seems pretty speculative to me on par with a kind of stem cell reefer madness. And Dr. Knoepfler’s response? “Exposure of cells to enzymatic treatment can dramatically change them”. You two sure seem to agree on a whole lot of speculation it seems. So, Dr. Knoepfler saw a talk on this many years ago? Who gave that talk? A member of the ISSCR, the CIRM or perhaps one of the perpetual research types who already believe that stem cells are drugs? Look. Just because something is possible does not mean that it is likely. And just because something can happen does not mean that it will happen. You’re the scientist. You run the scientific assays that you so mention. Clinicians are busy folks in case you have not noticed. How about consulting with a few of these regenerative clinics and work on these scientific assays for them? Or is it beneath you to assist those you seem to so vehemently disagree with right from the start? Maybe it’s just much easier to criticize from the sidelines.
    Regarding the types of stem cells that you and Dr. Knoepfler research, (primarily Embryonic and Induced Pluripotent) I think it has been fairly well established that there are serious issues with these types of cellular materials relative to immune responses and tumorigenesis not seen in their multipotent counterparts. And, that’s not just speculation either. I’ve read blog pieces of Dr. Knoepflers where he writes seemingly concerned with patient safety. So, what have you two, the CIRM or the ISSCR done to set up a CLIA lab to test all of these things that you just now mentioned in light of this concern about patient safety? Yet you want to place this very onus on those that I feel that you and Knoepfler already have a fairly obvious bias against. To me it seems you two are so determined to discredit regenerative medicine clinics that even if they were to do exactly what you both wanted of them (short of disappearing) you and Dr. Knoepfler would find some way of trying to discredit them.


    • Doug, for-profit clinics generally aren’t exactly eager to have independent labs analyze their products. Why? I think it’s because many of the products are basically junk. Dead cells. Debris. If the cells are living in some cases, they often aren’t really stem cells or are mostly other cell types. In other cases there are living stem cells in the syringe, but they just haven’t really been proven to be effective or safe with rigorous studies. So in my view it shouldn’t be sold.

      If I have negative impressions of most stem cell clinics it’s from watching how they operate, talking to them, talking to their patients, etc. for many years.

      If an FDA compliant investigational stem cell product is proven to have a high probability of being safe and effective, I then would support it regardless of the stem cell type.


  5. If “for profit clinics” are not exactly eager for independent labs to analyze their products, Dr. Knoepfler, then that raises the question of why Dr. Loring would make the point she did about clinical networks submitting to the several types of scientific analysis she mentioned in the first place .
    Are the University of California, CIRM, Scripps Institute and the ISSCR so strapped for cash that they cannot afford to run the tests themselves based on what is known about practices in these clinics like PRP as well as stem cell extraction from bone marrow and adipose tissue? Haven’t you gained enough intelligence about stem cell clinics based on your lengthy time of “watching how they operate, talking to them, talking to their patients, etc. for many years”? Put that intelligence to good use. Set up your own simulated stem cell regenerative clinic and run some tests. Then publish your findings in peer review journals. Other than cord or placental blood purchased from outside vendors, I’m not sure how you come to the conclusion that many of the products from regenerative clinics are “basically junk. Dead cells. Debris”. The clinic that I’ve frequented since 2014 does offer stem cell treatments. But those services amount to only a minority of what they do in terms of patient care. Other services include cortisone injections, as well as physical and prolotherapy. Their ultrasonic and diagnostic procedures recently revealed in me (from a former Army Doc) that I have an inguinal hernia. I thought I was suffering from hip arthritis for which the clinic could have made a tody profit off of me if they decided on a cortisone or PRP injection. The fact that they opted to be patient rather than profit minded in this instance tells me that this clinic is ethical and competent. They do not advertise for therapies involving cord or placental blood nor have they ever offered them to me. And sure! This clinic is a for profit center. But, so is the practice of medicine in this country unless you are in the military. And likely I think the reason networks and clinics will not run the scientific tests Dr. Loring mentions is because it is not in their financial best interest to do so. I do not think it has anything to do with their materials amounting essentially to “junk.” Run the tests, Dr. Knoepfler. I mean since you are so concerned with patient safety and all. At worst, you’ll find that adult stem cell treatments may be simply ineffective. Or perhaps you’ll find something along the lines of a proof of concept which has been demonstrated in veterinary models. (I’m thinking of the University of Colorado and their work with horses). At best you may find many treatments are safe and effective. The state of California is not supposed to be a business and by extension neither is the University of California. The ISSCR says that they are non profit and independent. You guys have money! I mean it’s either that or you can just keep blogging until you turn blue about how predatory you believe regenerative medicine clinics are. Until that day, I and many others who have benefited from regenerative therapies and don’t believe that we represent simply one big pool of anecdotal examples will continue to disagree with you.

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