Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc.

The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S.

It’s a big victory for science, regenerative medicine, and patients.

U.S. Stem Cell Clinic staff including Comella on the right.
U.S. Stem Cell Clinic staff including Comella on the right.

I don’t know if US Stem can continue its fat stem cell injections pending appeal or if the injunction is immediately in force, but I’d guess the latter. The court will issue a separate judgement in favor of the FDA telling us more it seems.

Why is this news such a big deal?

U.S. Stem (including its subsidiary U.S. Stem Cell Clinic and going by the stock symbol USRM) has become one of the most well-known fat stem cell clinics firms at least in part because of the documented loss of vision in some patients.

Its leader Kristin Comella is an outspoken voice for adipose stem cell clinics and for the idea that autologous fat stem cells should not be regulated as drugs by the FDA. She is influential in the stem cell clinic world and other fat stem cell clinics have also taken up similar mantras.

U.S. District Judge Ursula Ungaro apparently saw things differently (rightly, in my view) in ruling for summary judgment for the government. From the court order I linked to at the top of the post is this key section, emphasis mine:

“The Court agrees with the FDA that there is a reasonable likelihood that Defendants will continue to violate the FDCA. Defendants’ violations of the FDCA are not isolated; they have continuously performed the SVF therapy in noncompliance with CGMP as evidenced by the continued violations found in the Form FDA-483’s in 2015 and 2017. D.E. 50-1 ¶¶ 29-30; D.E. 45 ¶¶ 13-17. Moreover, the violations are not merely technical; when confronted with the warning letter and Form FDA-483’s informing them of their noncompliance, Defendants responded not by bringing their practice into conformity with CGMP, but by arguing that they were exempt from FDA regulation. D.E. 45 ¶ 20; D.E. 26 ¶ 52. Lastly, the Defendants’ business will undoubtedly present opportunities to violate the FDCA in the future as there is no indication that they have now complied with CGMP or adequately labelled their product. Defendants offer no challenge to these arguments, and as such, the Court concludes that the FDA is entitled to an injunction under 21 U.S.C. § 332(a).12″

While US Stem might continue as a business and focus on other stem cell-related products such as amniotic or bone marrow cells, I see that as a tough adjustment. Just as likely is the possibility that they will move the fat stem cell offerings outside the U.S.

With this court ruling under its belt, the FDA now has a very strong foundation to go after other risky, non-compliant fat stem cell clinics, with the caveat that USRM is likely to appeal and it’s at least formally possible that USRM could win on appeal even if very unlikely at least in my view. Some physicians who had been offering a la carte unproven and non-FDA approved fat stem cell injections have already stopped doing so over the last 6-12 months so a chilling effect was already evident.

Now comes the arctic blast.

This particular phrase from the court order is the key one, “the Court agrees with the FDA that the SVF is a drug under the FDCA and subject to its adulteration and misbranding provisions.”

More specifically the court decision also does not bode well for the defendants in the other still pending federal lawsuit by the FDA, also focused on fat stem cells.

Overall, again in my opinion this news is positive for both patients and the stem cell field.

More to come as I have time to read the full order, I get opinions from legal experts (which I’m of course not) and we get the additional document from the court.

26 Comments

  1. Great News. Shut them all down- “therapies” like this are a terrible thing for the regenerative medicine field as a whole. Unproven, unsafe and unethical.

  2. Dear Mr Knoepfler (or is it Dr Knoepfler?), I’m confused…
    If the “Mission” of this blog is to further the research and development of Stem Cell Therapies, how is this a “win”? ALL fat derived treatments shall now be suspect, no matter how well documented or effective, therefore pushing more patient towards Drugs and Surgeries that Do Not Work, nor resolve this disorders or improve lives of patients.
    Please explain how this landmark ruling will spurn More R&D, as the entire Regenerative Community turns its back to any and all SVF in fear of similar retribution from Big Pharma attorneys…
    This is a win for Big Pharma, not for America!
    ( And Yes, I Am A Doctor, Who Cares About Patients)

    • @Dr. Cole,
      You’re bundling everything together incorrectly. There are many legit clinical studies ongoing of SVF and related materials. If anything, this ruling helps clarify that the science-based studies of “fat stem cells” are very different.
      I also don’t see how big pharma cares about this one way or another. My impression is that invoking some myth about “big pharma” in defense of unproven stem cell clinics doesn’t make much sense.

      • Paul,

        Are there actually valid uses of fat cells (SVF), besides plastic surgery where fat is needed? I can’t think of any.

        Mesenchymal stem cells from connective tissue (in bone marrow and elsewhere) aren’t being used as stem cells in clinics – their promise (which is also very limited) is for a hit and run therapy, in which they induce some anti-inflammatory effect in the host and then leave. Since MSCs don’t live in blood, they are quickly removed by the body (unless they get stuck in the lungs). Luckily, they die of old age before they can do much harm even if they do stick. But a sarcoma decades later from a misplaced rogue MSC…entirely possible.

        • Hi Jeanne,
          Yes, there aren’t really proven uses yet, but I do think there may be some promise with this biologic if it can be proven safe and effective for specific uses. See a few real trials (e.g. from Mayo) amongst the 100+ studies listed in Clinicaltrials.gov website, noting of course that many are unproven stuff from clinics: https://clinicaltrials.gov/ct2/results?cond=&term=stromal+vascular+fraction&cntry=&state=&city=&dist= or others who seem over-exuberant.
          Paul

        • With orthobiologics we are not injecting them IV. Your are absolutely correct about the first pass effect in the lungs. But to throw the baby out with the bath water is also a clinical error and short sighted and we all hope that there is a regulatory pathway forward for PRP and BMC and other orthbiologics that HAVE been show safe for 30+ years in orthopedics and that have promise to help people where surgery and other modalities wither have not or can not or are risky with potential complications.

    • Being a Doctor does not a Stem Cell expert make. A slick presentation of untested ‘therapies’ is easily believed by many. The pitfalls of SVF injections are many- ectopic ossification has been seen in numerous patients and is not at all surprising given the nature of the cells contained therein. Processing a lipoaspirate and randomly injecting an unknown quantity of uncharacterised cells into various body parts is NOT a cell therapy and is not a good idea.
      (And Yes, I am a Doctor, who cares about Science, and has 15 years of lab experience witih Adipose tissues, MSCs, and has worked for Legitimate Cell therapy companies and am completely in favour of proven cell therapies).

      • Has anything been published about ectopic ossification in patients treated with SVF? Can you please provide a citation?

        • We have studies with 12 -30 years follow up with BMC that have not shown ectopic ossification or random bone spurring or cancer or other orthopedic pathology attributable to a bone marrow concentrate injection.

  3. I’m with Dr Cole.
    Adipose Stem cell derived therapy is one of the richest sources of stem cells. More rich that bone marrow, more rich than blood.

    This decision sets research back not forward.

    The rest of the world is doing much more than we ever thought about doing.

    Making adispose Stem Cell a drug.

    ARE YOU KIDDING ME?
    A DRUG????

    If I were stimulating it with growth hormones or other stimulus maybe. But adipose tissue. Really?

    Doctor you need to educate me how this is a good ruling.

    Stem cell hold great truth of treatment about many chronic diseases. This decision probably set the US BACK 15 years In stem cell research.

    • Oh dear. Who told you that stem cells can do all that?

      The FDA classifies these cells as drugs when and only when they are put into a part of the body where they don’t normally reside. This means that skin grafts from skin are not a drug, but fat cells or stromal cells injected into the bloodstream, spinal cord, or brain, are drugs. They don’t live there, and they cause problems when they are put there.

      Understand? The consequences of moving cells around to places in your body where they don’t belong can be horrible.

      Meanwhile, a lot of us are working on pluripotent stem cells made by reprogramming skin or blood cells into cells have the same abilities as embryonic stem cells. We don’t transplant these cells. We first turn them into a cell type that is lost, and then transplant them to augment or replace the cells that have died. Examples are retinal pigment cells for AMD, dopamine neurons for Parkinson’s disease, pancreatic islet cells for Type I diabetes. In each case we put the cells in the place where they should be- neurons into the brain, retinal cells into the eye, and islet cells into the body in places where there is rich blood supply to deliver the insulin they make.

      • So what are the effects of having svf cells injected into the joint cavity, i have had this done in numerous joints, should i be worried ? Is there any research data from adverse effects?

        • @Carol,
          Note that I’m not an MD so I can’t give medical advice.
          There also are not a lot of controlled studies on adverse events published so we there’s quite a bit we don’t know yet.
          My general impression though is that there haven’t been that many negative outcomes reported from joint injection of SVF. There also isn’t really proof it does any good either.
          Still, there are going to be some risks both short term and also with a living cell injection there could be longer term risks we don’t understand yet. If you are concerned and/or have unusual symptoms in injected joints, talk to your doctor (not the one who did the injection). I wish things were clearer but the data just isn’t out there.

          • Paul,
            I noticed your comment “there are going to be some short term and also with a living cell injection there could be longer term risks.” Could you be more specific about what you envision these “risks” to be? We’ve been using the saphenous vein in the leg for coronary bypass surgery for 60 years…are you also recommending we discontinue this practice? There has to be living cells in these veins. I just would like to know why you think a person’s own cells are potentially SO dangerous to themselves? When you give an answer like “we just don’t know” you sound a lot like an academic protecting his own interest. It seems those most passionate about the dangers of the therapeutic use of a person’s own cells are those with an agenda. There is a specific model for medicine in our country, and people are less and less inclined to believe patient safety is a primary concern. The FDA has proven time and time again that they are more committed to protecting industry than patients. The way I see it…researchers are just trying to protect their interests, “big pharma” is out to protect their interests, hospitals, insurance, all doing the same. Take a hard look at who’s making the big money around medicine and how changing the paradigm of healthcare would affect them, and you’ll have a better understanding of the motivation of all involved. Medicine in this country today is all about who gets paid….who’s paying you?

            • @BH Robert,
              Fat stem cells manufactured into a non-naturally occurring product can pose unique risks such as abnormal tissue growth and pulmonary embolism, just to name 2. Compare this to a non-motile, non-proliferative segment of blood vessel that wasn’t modified. Not a very apt comparison.

              I have no connections to “big pharma”, which in certain cases I can see has done a lot of harm, but I don’t see as some kind of universal evil empire. Do you have particular “big pharma” companies that you think somehow are working to impair stem cell/regen med clinical research? I haven’t seen that.

              What I blog here is my opinion and sometimes that includes criticism of academic and pluripotent stem cell work that in my view was hyped or has problems. Read some of my other posts just from 2019 and you’ll see what I mean. For me a lot of it boils down the quantity and quality of the data rather than what type of stem cells we are talking about, and balancing risk vs. potential benefit for patients in need.

  4. The question I ponder, over and over again in this field is what sort and degree of, regulation we need in place. Have yet to see a major regulatory branch of the FDA, perform a service which was more beneficial than hampering. We currently work under the “auspices” of a regulatory office which is clearly nothing more than a brake on innovation, without large amounts of money. This does, by its very nature, presuppose the ‘rightness’ of progress to those ensconced companies which have already been through the process as well as those with political pull.

    The companies with drugs, and lets face it, most treatment in the world are via a ‘drug’ of some kind. We think of ‘surgery’ as the “big” intervention, but it is commonplace drug, which pervades our medical world. The ‘laws and rules’ are written my bureaucrats put in place by political appointment, provided, In large part, as a ‘recompense’ for political support, either personally or as an appointment to appease financial support by companies. In the last 20 years, we’ve had 8 FDA Commissioners.

    Now, I’m not headed down the “Big pharma” road, that is not my intent, however, it is a fact that there is major influence by large companies in maintaining control. It is the control, of what I believe will be a major shift in treatment, which I am discussing. If treatment shifts away from pharmacy to PRP/BMAc, there is no money in it other than for the actual physician doing the procedure and perhaps the company providing the concentration disposables. This is exactly what has hampered research in the field. The lack of sufficient financial ‘endgame’ to justify such a large investment of money to fight through the current FDA process, only to have a “findings and a paper” at the end.

    All this is NOT to justify SVF nor the loads of unqualified charlatans out there doing nothing useful, and quite often loads of harm. Either through dangerous procedures or simply useless procedures at a high financial cost for patients. This, is where we need to find a solid base. This is the question we need to be asking. Right now, any chiropractor can hire any RN or PA and open a STEM CELL Clinic. The DC cannot give an injection, but can tell an RN or PA where to inject. This is nothing more than skirting a rule which is designed to prevent harm and/or the very thing we see in this field today. But, let’s not stop there… there are many MDs and DOs who are also inept in both understanding and technical ability, who are “legally” performing useless or potentially harmful procedures.

    This is not simply the preview of illegality… it is even greater, simply regular medicine. 1. To what degree is the procedure likely to harm the patient. 2. Is the procedure the”correct” procedure for that patient? 3. Does the physician have the qualifications to perform the procedure adequately? 4. Does the physician have the facility and tools to perform the procedure adequately? 5. And finally, and this is where I see a breakdown in the system so very often, did the qualified and capable physician do what he thought he did? Ie, Did he inject WHERE he intended? Did he inject WHAT he intended?

    How do we, as well intended people in the field, address oversight, when there are so many moving pieces on the board? Who should say “this is ok to do, but you and you cannot do it, but YOU can”? Who is to say these are the baseline requirements? How should we regulate ourselves?

  5. The ruling is not about “unproven” fat stem cell clinics, it is about any clinic that does not follow cGMP standards.

    The ruling specifically states that US Stem Cell Clinic, LLC, did not follow Good Manufacturing Practice nor did they label their product correctly.

    This can’t be reasonably reported as “a major defeat for… the hundreds of other unproven fat stem cell clinics in the U.S.”.

    This kind of hyperbolistic reporting undermines what is otherwise a sensible blog.

      • The judge didn’t say that fat stem cells should be regulated as a drug. She said that SVF, in this particular case, is a drug because:

        1. they advertised the SVP for a non-homologous use (= section 351)
        2. they claimed it could heal (labelling = FDCA)

        and, as it is a drug, she also decided:

        3. the drug was adulterated (because is was non-cGMP)
        4. the drug was misbranded (it didn’t have correct labelling as it is a drug)

        In my view, it would be quite simple for another clinic to get around these points by simply avoiding the same mistakes:

        1. don’t claim it can be used to treat anything
        2. conform to cGMP standards

        However, the defendant would have to show that SVF is minimal manipulation and if they digest, as I assume they do, they would fail here and it would still be a sec. 351 but may be a device not a drug.

        • @Fudge,
          You make some good points. I doubt another clinical could simply get around the hurdles. For one thing, SVF is broadly defined as a drug based on enzyme use, and also there are few homologous uses of it. Paul

  6. Paul- exactly. Many of these clinics have poor or no GMP manufacturing, and that’s shocking. But they are a drug.
    P.S. I’m not sure that anyone reads your comments or mine. I thought I was pretty clear, as were you.

  7. Any industry, organization, or so-called “clinic” that charges desperate people with chronic diseases thousands of dollars for treatments that do not work should be shut down. I have dealt with lung disease patients for many years as an advocate, and I have seen shameful examples of the fleecing of the unfortunate, the uninformed. The legitimate research being carried out at Wake Forest, at Houston, etc., can only cheer at this decision. If nothing else, it lends legitimacy to their work.

    Jim Nelson

  8. I fell for it. I had U S Stem Cell take out fat cells and put them in spine after my stroke. It’s been two years and I lost over $10,000. I wish I could get my money back. Nothing changed at all. I was duped. I could use that money for a lot more promising things. Any ideas how I can get a refund?

  9. I am a recipient of stem cell injections; I had my body fat used and properly prepared. Properly injected.
    I say properly as Im not a doctor. I know the stem-cell count, I know the dangers to be near 0. I know the dangers of opening my rotator cuff area to be far more dangerous than a syringe.
    I had 15 years of pain, I had limited mobility of my shoulder. After my own cells were injected i had some surprising results. I had movement, I had nearly no pain, I had started working out at the gym. I improved, this was about 4 years ago. I have had only positive results. NOTE MRI, x ray , etc. Doctors wanted too use traditional surgery; this was too scary for me so i lived in pain. THE risk vs reward is obvious. I had spoke to many whom had both surgery done and had other areas repaired with stem-cell The stem-cell recipient had expressed much more satisfaction than the open invasive methods WHY does the Government feel there is a negative against stem-cell. SO fare in orthopedic use 0 issues 0 damages 0 deaths 0 complications 0 negative reports IF the tissues is-collected and blood work is proper this should continue VS forcing people too use old fashions surgery. Maybe it’s the Doctors who are wanting the big money whom are preventing this ? maybe it’s the drug companies, But i believe in NO harm NO fowl
    Im lucky I had the option of either treatment. I am having my knee done and my other shoulder done next

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