Sales of ‘zombie’, birth-related ‘stem cells’ continue to mushroom

Zombie

The birth-related stem cell clinic industry is a serious problem for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections.

One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was predicted by the data that Leigh Turner and I published in one of our collaborative papers in which we saw an upward slope in the number of businesses selling amniotic or other birth-related “stem cells”.  By “birth-related” I mean amniotic, placental, umbilical cord, or other products that result from the birth of a new baby.

The numbers were still very small at the time of our study, but the trend was clear. Still, at that point I wouldn’t have guessed that we’d find ourselves in early 2019 with a massive number of clinics selling birth-related “stem cells” from coast to coast. There could easily be 100-200 of these clinics or other individual practitioners selling this stuff. Why the big growth here? Suppliers and marketers are driving the expansion by convincing chiropractors (and some physicians) to sell their unproven and non-FDA approved products.

Zombie

I speculated in a post “Wanted Dead & Alive” a couple of years back that some for-profit clinics and suppliers in this area are selling products that aren’t really living stem cells (they are “dead” extracts), but they still market the products as both living and stem cells. Hence, there’s my opinion that this is a “zombie” kind of thing.

To be clear, some birth-related products (when not in vague “zombie” form, but instead produced in appropriate clinical-grade facilities by experts and validated to contain living cells of defined types) are promising for certain applications and are being studied in many clinical trials, but should not be sold today.

There are big, unanswered questions here. For instance, where do the birth-related products come from? How often are they either be contaminated or have not been probably tested for pathogens? Do the new mothers know that the materials from the births are being sold and possibly resold? Is it possible in many cases mothers have not consented to the use of the brith-related materials?

Also, could some of the products sold in the US be produced from overseas births? I have heard this is likely the case for some suppliers, but I haven’t seen concrete evidence of this. The lack of clarity about the sourcing and validation of birth-related products being widely injected into patients is very worrisome.

For instance, in the last few months we learned that 12 people were reportedly hospitalized due to contamination of a birth-related product being marketed by Liveyon and apparently produced by another firm called Genetech (not Genentech). Somehow the product became contaminated (or was contaminated to start with?) with various kinds of bacteria before it was injected. Fortunately for other potential patients, the product was recalled by the FDA.

This doesn’t seem to have made much of a dent in this birth-related “stem cell” clinic sector so far, but we’ll see. There also have been at least two and perhaps more patient lawsuits against firms in this area. I expect that number is already growing and that could rein things in somewhat too.

The FDA needs to get moving in this area since the products are marketed as living cells, which in allogeneic form and often used in a non-homologous manner would be unapproved drug products. If there are no real living stem cells in most of these products as many of us suspect, then the FTC needs to take some action here quickly too.

Paradoxically chiropractors are the primary ones selling birth-related ‘stem cells”, even though they themselves cannot legally inject them. In my opinion, these chiropractors pitching stem cells are essentially working with suppliers and physicians to just extract more money from their client base, without a reasonable expectation of benefit to the customers and with definite risks. Chiropractic associations needs to take some kind of major action here.

Overall, how do we get out of this zombie, birth-related “stem cell” mess?

The possible solution seems to be a combination of educational outreach to patients/consumers and bold action by multiple levels of regulators. It’s not encouraging that in the fat stem cell clinic arena, which is even bigger as well as being years older, and has some major problems of its own including hurt patients, we haven’t seen this kind of big impact yet by regulators.

15 Comments


  1. Off-topic perhaps, but about two years ago, I saw an ad on my FaceBook feed, for a stem-cell clinic in California. I have a neurodegenerative disease, and my heart leapt. I was thrilled by the prospect. Then my natural skepticism took over. “Too good to be true.” And why hadn’t I heard of it before? I was trying to track the procedures down, and couldn’t , for the very good reason that they are chimeras, and I started worrying about those not as skeptical as I…who would tell them? I have no bonanfides. Then I found you and that was that. I haven’t thanked you! I won’t go on, because I would go on and on, but there is no question in my mind that those claiming miracles with stem cells are imposters. Poseurs. In it for the money. And you are out to expose them. Thank you.


  2. One of the rumors in what I like to call the “perinatal” space it that the since the cells are immunologically naive, there is no need for histocompatibilty matching and GVHD incidence is “0” – to this I show clinical paper after paper showing low GVHD rates, but not 0%. And you are right, cannot replace a patient questionnaire for pathogen testing and need a solid, IRB approved Donor Consent Form. The zombie cell space almost gets intermingled with the “compounding pharmacy” disasters of 2011-2013 – a lot of manipulations (think about how many from the delivery of the placenta to spinning down cells to counting them and then filling a unit dose) which at each manipulation may contaminate the patient dose and make them sick (or worse). And anything which is sold for intra-articular injection (anything that by-passes the natural defense systems of the skin, mouth, nose, lungs, eyes) must be sterile. That means whoever makes it must prove it – must conduct air/surface/personnel monitoring for viable and non-viable particulates, do sterility tests and “Media Fills” of their validated processes. It’s a big deal to do it the right way.


  3. Paul and Kim,

    We truly appreciate your work on the Niche and the platform it provides for Doctors, Scientists and all people involved in the loosely coined term, “stem-cell therapy.”
    Your article questions where the real regulation and implementation of regulations begin to provide protection for people before more are hurt and duped. I wonder, with Federal workers limited situation, some not working and some still showing up for work but not being funded to do their jobs, perhaps,how this situation might affect the proliferation of these “zombie” or “ white walker” businesses because, according to the link below, there are over 2,300 361 FDA Registered HCTP’s companies that seem to include clinics, tissue banks and more!

    https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/Index.cfm?fuseAction=fuse_DisplaySearchResults

    Are dead human tissues being possibly injected into living humans and why? According to the BioPharmGuy, there are at least 223 stem cell & cellular therapy companies worldwide. I realize that some of these involve organ transplants and material used in surgeries, but since Liveyon’s FDA ReCall, it has expanded into the Blue Zones including Mexico, Vietnam, Indonesia and with the disappearance of Genetech ( creator of Liveyon product) following the FDA’s detailed warning letter, there has been the new appearance of a FDA Pre- Registered company called, Liveyon Labs, Inc. In California.

    We created a website to help people avoid the stem cell scam ( avoidthestemcellscam.com) as from our unfortunate experience, we also feel like the best way to help breakthrough the most probably purposefully created confusion of including 361 Registered HCTPs in the term “stem cell therapy” is to research platforms like the Niche and our own lay person’s self created website that details our experience and HOW we discovered that we had been scammed as well as understanding the stem cell scam sales pitch and how to know if a DC, an MD or other is trying to sell you a dead tissue product.

    Editor’s note: comment edited for compliance with blog comment policy.


  4. Can you please advise what I might do to effectively warn unsuspecting people in my area about our local birth related for profit stem cell clinic who is currently direct to consumer advertising yet another round of free stem cell therapy seminars? It’s so disgusting those in pain are being taken advantage of in this way.


  5. James,

    Is it possible to obtain your documents that you mentioned that you could share publicly from when you were an advisor for Genetech?
    Thank you for posting your helpful comments!
    We were duped by the sale of The 361 FDA Registered HCTP, Liveyon, where a MD and a DC told us that we were purchasing actual living stem cells and we wanted to help people understand how these are being sold vs what is actually in the purported, “ stem cell therapy” products.
    Please see avoidthestemcellscam.com and/or email us at [email protected] Gmail.com
    Thank you!


  6. Ifit walks,

    Paul posted an informative and helpful piece on November 8th on how to report a bad clinic on the here on the Niche.
    We are those that are in pain, dealing with multiple issues and we were lied to about the Liveyon product and were told that we were buying living stem cells. After 4-6 months, $30k + and not any of our 3 family members getting any of the results that were promised, we began to research and found out just how we were duped. We created a website to help people learn how to avoid the stem cell scam. Feel free to visit avoidthestemcellscam.com.
    Thank you for being of service to citizens with your caring questions!


  7. I understand that selling a contaminated product makes the company liable for any wrongdoing. What about labs just processing cells, let’s say enriching bone marrow cells or umbilical cord blood for storage (private banks for example) and also sells them. One: are there FDA registered companies that sells them to private practice? And second: is the liability then on the doctors who inject rather than the company?


  8. Daniel – it is a similar regulatory climate as with the blood. platelet, plasma and the tissue/organ donation industry. Companies who practice in these trades are regulated on different levels by trade industries (hospital legal and physician licenses), local codes, etc. The FDA gets involved with the consent, collection, processing, storage and distribution of cells and tissues. Whole organs for transplant fall under medical practices. So yes there are hundreds of Companies that are in compliance with FDA regulations for collection, processing, storage and distribution of UCB and marrow cells. These firms don’t generally get involved with private practice – rather they work through trade groups – places that liaise the patient, physician and suppliers. So in order to provide compliant collection, storage and distribution system, you would need to be an FDA approved facility. That means you would know that you cannot distribute your product for human or therapeutic use unless it is approved. The FDA Guidance on these things is in many long and complex documents, so there is a great deal of debate how they are interpreted. My interpretation is that the Guidance very clearly says if you make, possess, store and/or distribute anything injected in humans by a Doctor – the liability lies with both the supplier and the physician and potentially anyone in between


  9. Yes, there are scams out there. Yes, there are deceptive clinics, more than deceptive, outright dishonest. But I am a living example of what stem cells can do. Not stem cells that have been manipulated into a drug but true living, robust stem cells derived from umbilical cords. In 2010 when I had my first stem cell treatment for multiple sclerosis, I could not stand on my legs for longer than a moment. I had ordered a scooter because, although I needed a wheelchair, I just couldn’t wrap my mind around it. I also had enormous problems both with my bladder and with my bowels. Today, after 9 treatments, because we know that not every treatment is going to give repair, I can stand on my legs for hours and I am no longer using a cane nor do I need a wheelchair. The internal stuff is all fixed. Yes, we need to do our research. But the regenerative potential have stem cells is undeniable.
    Judi Lecoq


  10. Stem cells and the materials they contain – even dead cells – are clearly transforming medicine. That said, there are definite quality concerns with some stem cell providers.

    My concern is FAAR greater than whether an adult gets ripped off, sickening though that is. What we must look at most closely is HOW these products are obtained, as you point out correctly. Know that anemia is correlated with early cord clamping, which is clearly incentivized by birth-related stem cells. Breastmilk contains NO iron, to protect baby from bacterial infection.

    Babies deserve better than to have their umbilicus clamped and cut and sold within 3 minutes of birth. Primates leave cord intact for hours or days in the wild. Iron levels are PROVEN HIGHER. And much needed for baby!!
    birth #stemcells are stolen tissue!


  11. Hi Judi,

    Glad to hear your success story. Would you mind to share exactly HOW you received actual living stem cells? How do you know that they were actual living stem cells?
    The reason that I would like to understand is because my family was scammed by a DC and a MD making false claims that their product contained actual living stem cells when by the recent FDA Recall and CDC report and more, this company was only a 361 FDA Registered Human Cellular Tissue Product which, as you may know, means that the product does not contain any actual living stem cells at all or they would have to pay millions of dollars and perform years of documented clinical research to be a considered a FDA 351 Approved Drug, which as far as we have researched are only used for blood to blood transfers in cancer patients.
    Also, we noticed that the DC and MD said that we needed to buy a type of bio-electric- magnetic bed
    ( pemf) to promote circulation and to help proliferation of their purported “stem cell therapy” and they combined this 361 HCTP with our own blood platelets at the same time to inject into us for spinal cord, vertebrae, nerve and joint repair and more. They said that the purported “ living stem cell therapy” product would “ home” in and go to work exactly where it was needed. Obviously, it did not work and our eldest family member became very ill with a severe infection requiring hospitalization and multiple surgeries from a gastrointestinal rupture to a toe amputation and more shortly after receiving what we were told were actual living stem cells. He received 2 slow push IVs per the DC’s medical consultation.
    Did you go to a hospital and wait for a live birth? If so, how did you coordinate that?
    Also, it seems that some of these products have been irradiated and cryogenically preserved which may indicate dead or damaged tissue that do not live very long after injection anyway according to research and doctors that perform bone marrow aspirate? Did you use your own body cells from adipose or bone marrow, by chance?
    Thank you!
    Avoidthestemcellscam


  12. Mr Franklin,

    How is it that dead cells are transforming anything given they are dead, irradiated or cryogenically preserved?
    Our experience with dead tissue yielded nothing except an increase in treatment and hospital costs. They might be transforming the profit for medical, but what else?
    Also, With all the tissue banks and “stem cell manufacturers” in the world and with some companies that may be expanding to 3rd world countries with “ Blue Zones,” could this “ sourcing” constitute a host of possible violations?
    Interestingly, an allograft HCTP can contain tissues sourced from not only human umbilical cord tissue, but can also contain, equine, bovine and more. What happens when these allografts are sourced in other places without any regulation? Some in the US seem to just be going rogue with this loose adaptation of what is allowed in allograft tissue.
    We know people in Other countries that birth at home and leave the umbilical cord attached with placenta until it breaks away naturally, usually 3-4 weeks, as they say the baby is receiving what it needs from the connection even after being born.

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