FDA recalls Liveyon stem cell product: blow to big clinic supplier?

LIVEYON
Screenshot of part of LIVEYON homepage

The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.”

An emerging big player in the birth-related stem cell clinic area?

I’ve been hearing the name Liveyon pop up more often in the unproven stem cell clinic industry recently. More specifically, they seem to be a supplier and marketer of birth-related products to clinics. The clinics then in turn inject the non-FDA-approved offerings into customers for profit. I have only mentioned this particular company once on this blog before. It was in a post about a clinic that apparently used their product for neuropathy, which was not a recommended indication.

LIVEYON
Screenshot of part of LIVEYON homepage

The birth-related stem cell clinic industry more broadly has really taken off the last few years and now constitutes a sizable slice of the clinic pie across the U.S.

Liveyon has been part of that growth.

Umbilical cord stem cells + growth factors

The company’s splashy website (see image of part of the homepage) focuses on umbilical cord “stem cells”. I’ve never really been clear as to whether the products of this supplier and others in this birth-related area including amniotic materials actually have living cells or are just dead extracts (see my past post Wanted Both Dead & Alive).

From the Liveyon website:

“Liveyon provides high-quality, medical grade umbilical cord cells and growth factors for use in research studies for various degenerative diseases. By combining stem cells and growth factors, our product may give a longer lasting effect and improve quality of life for those suffering from debilitating diseases/ disorders, such as arthritis and orthopedic indications. Our product testing makes you, the skilled practitioner, feel comfortable that your patient is receiving the best product available in the market.”

This sure implies living cells. What are “medical grade” umbilical cord cells? Hard to say.

If the cells are indeed living and because they seem to be mixed with growth factors, in my opinion it would seem this product would require a cleared FDA IND prior to marketing or use in patients. I suppose the company could have an IND, but I strongly doubt it.

Thinking about the recall

What specifically made the FDA recall the Liveyon ReGen product series?

The FDA notice says, “Consignees were instructed to not use the vials, due to reported adverse reactions.” More broadly, I have heard of some apparent adverse reactions to birth-related “stem cell” products through the grapevine, but I haven’t confirmed any or gotten many more details. I wish we knew more about the adverse events here. Maybe we will learn more later.

The FDA verbiage suggests to me that Liveyon isn’t the manufacturer of its products, which is instead attributed to another company Genetech, Inc. (not to be confused with the well-known biotech, Genentech). I’m not sure what Genetech’s story is, but a different site suggests that they have 12 employees, $8 million in annual revenue, and that they also manufacture antibodies.

Looking ahead

Does Genetech send the same or similar products to other clinics and are those products of concern too?

How many people were injected with Liveyon’s recalled product? Will they have their health monitored? Again, what exactly were the adverse events and how many occurred?  I used the Liveyon’s “contact us” online form to ask these kinds of questions. We’ll see if I get a response.

Who runs Liveyon and are they some kind of expert? A physician? A highly experienced stem cell scientist? What do they have to say about this recall? Stay tuned.

Finally, I am curious as to whether the FDA will do anything more about this situation.

29 Comments


  1. I have heard/learned that the contamination was E. coli. This is terrible for the patients injected…I also haven’t seen any numbers of affected patients. I am sure the patient driven lawsuits are just about to be reported if these facts are true. Sadly, for an allograft product with no living stem cells…which is what was being sold to the doctors and patients….all the twas delivered for some was living E. coli bacteria.

    Doctors and patients need to carefully evaluate EVERYTHING from marketing claims to clinical outcome claims. This particular company, Liveyon, was started by Jason Kosolcharoen whose prior legal troubles included SEC actions and health care fraud actions.

    SEC Action/Settlement for securities violations
    https://www.sec.gov/litigation/admin/2014/34-73378.pdf

    2016 Health care fraud involving compounding pharmacy…(right before Liveyon was started…)
    https://www.ocregister.com/2016/06/23/seven-from-oc-arrested-in-nationwide-health-fraud-sweep/


    • @Don,
      Thanks for the background.
      Do you know anything about the supplier Genetech, Inc.? If you are right that there was E. coli, it’s possible it was already there when the product was given to Liveyon.


      • I have been trying to get more info on them. SO far no significant success….especially with the name confusion with the Roche company. For sure will let you know if more is released or located on the Supply chain. I think you are likely correct in that the product was supplied to Liveyon and then forwarded on with new labelling by Liveyon…with whatever was in the bottle from Genentech.


      • Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series® Product, Manufactured by Genetech, Inc
        Irvine, CA, October 5, 2018 Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

        Liveyon
        Liveyon
        IRVINE, Calif. – Oct. 9, 2018 – PRLog — The Center for Biologics Evaluation and Research (CBER), a division of the Food & Drug Administration (FDA), which oversees human cells and tissue-based products, contacted Liveyon on Thursday, September 27, 2018. CBER stated concerns related to the products manufactured by Genetech and informed Liveyon of reported possible adverse reactions due to the use of the ReGen Series® product. Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions. In addition, Liveyon voluntarily recalled any Genetech products it may have distributed.

        Working closely with the FDA, Liveyon has executed a strategic recall action plan and has immediately begun the voluntary recall process. The decision to stop shipment of Genetech products and implement the recall was to ensure the safety of all patients, regardless of whether the adverse reactions were product- related or the result of any procedural misuse of the product.

        Liveyon immediately discontinued the purchase any product from Genetech and has procured new product from an alternative manufacturer. Liveyon has secured a manufacturer which has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility. The new manufacturer is a US-based, FDA registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the America Association of Blood Banks (AABB). It is a member of the Be The Match Program and has passed all FDA inspections.

        Liveyon will resume distribution of the new product line effective Monday, October 8, 2018.
        Sincerely Yours

        John W. Kosolcharoen
        Founder/CEO
        Liveyon LLC

        Media Contact
        Erin Sairafe
        [email protected]
        800-578-0983


  2. I have had representatives from this company come to my office several times. EACH time I asked them for ANY evidence of efficacy for the various Orthopedic Conditions they were promoting. Each time there was NONE ! They reassured me that the product was being used by Pain Mgt and other physicians in THOUSANDS of patients. I suggested that we perform a small study at least in ONE area of Orthopedics AFTER they got FDA approval/ IND. I even drafted a study prppisap for them. They disappeared EACH time.
    ALL of these companies are promoting non FDA compliant use of their products and should be investigated !!!!


  3. SETTING THE RECORD STRAIGHT ON LIVEYON CORRECTING THE GOSSIP AND SPECULATIONS

    The recall of the Regen Series distributed by Liveyon was done voluntarily by Liveyon after being notified by CBER, the division of the FDA that oversees human cells and tissue-based products. of their concern that Genetech, the cord blood supplier to Liveyon, had fallen out of compliance with cGMP (Certified Good Manufacturing Practices). Coincidentally, and not at all related to this recall, was the revelation by an informant/whistle blower, that a physician in Florida was not following Liveyon protocol. Several of those patients developed e coli infections. However, patients in other clinics who received Regen, the LIveyon stem cell product, from the same batch/lot did not develop any complications, nor were any of the unused vials from that batch contaminated. Further inspections of the rogue clinic revealed that the ultrasound head, which was not covered with a sterile shield, tested positive for e coli, as did the ultrasound gel and several other items in the treatment room. Furthermore, the treating physician was reported by one of his employees to not be wearing sterile gloves. The evidence strongly supports that the infections were iatrogenic and not product related.
    Liveyon is the only fully FDA compliant stem cell company and recently passed an impromptu inspection with four small corrections that were immediately implemented. Liveyon operates a cGMP compliant lab with ISO 7 clean rooms which are thoroughly swabbed every 2 weeks. LIveyon also employs a full time compliance officer. Before any product is released for shipping it must pass a USP 71 protocol,wherein the cultures for bacteria, viruses and fungi are held for 14 days. This is very significant, since some e coli strains will not grow out and be detected before 10 days. The normal send out of most labs is only 3 days.
    Liveyon has since replaced Genetech with a superior manufacturer which has been in business for more than 15 years and manufactures the new Liveyon product in a cGMP compliant facility that is a US based, FDA registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the American Association of Blood Banks (AABB). It is a member of the Be The Match Program and has passed all FDA inspections.
    There is no need to panic or rush to conclusions for which there is no supporting evidence. While it is true that the stem cell industry is crowded with many snake oil salesmen and hucksters who import their products from third world countries, Liveyon has remained absolutely FDA compliant and represents the gold standard in the industry against which all others will soon be measured. LIveyon’s stellar and established reputation in the medical community is reflected by the fact that Liveyon ships twice as many stem cells as all the other suppliers combined.


  4. Pharma shill! That’s what I got by exposing “stem cell” clinics. Let’s keep putting dishonest clinics/people out of business.


  5. The best part about Lynne Pirie’s written “clarification” is it clearly delineates the fact that Liveyon is still actively marketing an allograft product with advertised living stem cells DESPITE only having a section 361 registration and not RMAT art IND/BLA with the FDA. I am not sure what else the FDA needs.


    • Hello Don
      Liveyon is very much in compliance with the FDA 361 guidelines: –
      1. not more than minimally manipulated
      2. intended for homologous use only (performing the same basic function in the recipient as in the donor
      3. is not combined with another article and
      4. does not rely on a systemic effect or is dependent upon the metabolic activity of living cells for its primary function.

      The FDA recently visited Liveyon and inspected their Yorba Linda facility and was quite impressed with the overall compliance of Liveyon. If there was any 361 violation afoot, clearly it would have been exposed. Please contact the Liveyon compliance officer Erin Saiafe for further information.

      May I add that as a former physician for over 25 years, I would never lead any colleagues down a blind path that would place their license or liberty at risk. I have been involved with other stem cell distributors and either did not join or left for good cause as I saw violations of the above guidelines. Additionally, The LIveyon products are the only ones for which physicians can obtain malpractice insurance with certain major companies.
      Best Regards
      Lynne


      • What is the homologous function of umbilical cord blood in orthopedics?
        Another major publicly traded company, MiMedx, went thru the time and expense of getting a RMAT for amniotic fluid in an orthopedic application specifically because the allograft products are NOT homologous and Mimedx doesn’t even claim living stem cells in their products, Although their product actually does meet section 361 as not being dependent on living cells (a claim that Liveyon DOES make)…their product still did NOT meet section 361 because of it being non-homologous and thus they did the correct thing in seeking a RMAT for their use of it in knee osteoarthritis. They could have also gone the route of a IND/BLA but the new RMAT process seems more streamlined and potentially easier to utilize by companies in the regenerative medicine space.
        If you remember FDA actions in 2013 against Osiris Therapeutics, for another allograft product marketed as having living cells….this is what the FDA said: “in addition, Ovation® and your products, Grafix PRIME®, Grafix CORE®, and Grafix XCTM, do not meet the criterion in 21 CFR 1271.10(a)(4)(ii) because the products are dependent upon the metabolic activity of living cells for their primary function, and are not intended for autologous use or allogeneic use in a first or second degree relative.”
        I don’t understand how Liveyon claims otherwise for also advertising an allograft product with living cells just like Osiris did.
        Ultimately, it is not up to either of us…..the FDA and CBER have a direct mechanism to submit your marketing and product and manufacture process to see whether or not your product is appropriately registered as a biologic drug or not. I would urge you to submit your product to the FDA/CBER and if they confirm that you are appropriately registered under section 361, I will be amongst the first to consider testing the product for appropriate indications. Right now, the classification as a section 361 allograft product with living stem cells, which is what Liveyon is claiming as you state, would certainly seem at odds with prior FDA actions dating back at least to 2013 and further clarified in the November 2017 Final Guidance docs. If you do submit please let us all know so we can follow the progress of the submission to see what the FDA rules!
        I have no desire to argue with it when there is such a simple well established, public regulatory arbiter who will tell us if you simply take the time to submit your data. Please do.


        • Thank you Dr. Buford for your very thorough reply. I am currently working on the comprehensive answer.
          I checked out your web site and was very impressed that you have been able to excel not only as a professional baseball player, but also academically and as an orthopedic surgeon. I did try to call your office but received a voice mail recording that did not identify as being connected to your clinic. Is that the correct number?


      • We both know that FDA inspections are not done to establish section 361 versus 351….to state such is simply not true. No FDA inspection letter has ever commented on section 361 or 351 status to my knowledge and yours did not either.
        The mechanism for determining section 351 versus 361 is done by you submitted your marketing, product, and manufacturing process to the FDA/CBER divisions and asking them to confirm your section 361 registration. To my knowledge Liveyon has never done that….I ask you simply why not? I have the las and I am happy to post here if you want.
        The piece about obtaining malpractice coverage for Liveyon products is just something I don’t understand. I have malpractice as an orthopedic surgeon…it is not tied to a specific product and hasn’t been for 20 years…whether in surgery or not….so I frankly don’t understand that….if you want to explain that please do.


        • Sorry for the typos…I was simply saying that I can provide the Links to submit any regenerative medicine product to the FDA for their regulatory opinion. To my knowledge, no regenerative medicine manufacturer or distributor claiming to see allograft living stem cells appropriately under a section 361 registration has ever has it confirmed by the FDA, which is a shame since it is an easy thing to do….takes a day to submit the application and maybe up to 4-6 months for an answer if not sooner….and begs the question of why none have?


  6. The FDA letter was clearly NOT a polite inquiry to Liveyon. It clearly states that “Consignees were instructed to not use the vials, due to reported adverse reactions. Liveyon will be coordinating product return for a full refund.”

    As expected, Liveyon is attempting to portray this as a voluntary recall…..I would love to see what happens if Liveyon stops their “voluntary” and not FDA mandated….recall….


  7. I am assuming Genetech (the last supplier)_ was also vetted by the distributor Liveyon and thought to be the best at that time…..now there is an immediate pivot to another supplier…..but supposedly the process is proprietary….red flags.
    The bottom line with companies marketing these allograft “living stem cell” products is now we have yet another example of significant proven risk of an expensive allograft product with minimal human outcomes data for any orthopedic application…compared to PRP or bone marrow derived stem cells….neither of which have regulatory issues and both of which at least have data in orthopedics supporting efficacy in many clinical conditions. Why would I sell a patient a therapy when there is a cheaper, safer, more studied alternative with no regulatory issues? That is the clinical question for us in the field in regenerative medicine!

    I don’t want to hijack Paul’s thread so I will bow out and await Liveyon’s product submission to the FDA/CBER to confirm appropriate regulatory classification.


  8. Yes, Don is correct and Lynn is not. Liveyon as a 361 allo tissue vendor is not permitted to make a live cell claim and this is clear from other warning letters to other 361 birth tissue vendors. In fact, merely the claim bumps Liveyon from a 361 tissue with a quickie 45-minute online registration to needing a 351 cell drug approval with clinical trials required for each indication. That claim is independent of whether Liveyon actually has any live cells. I have confirmed this many times with regulatory council (Andy Ittleman).
    Yes, Don is also correct that an FDA inspection of whether a lab is meeting cGTP (which is the standard a 361 tissue vendor would be held to and not the claimed cGMP which is a drug manufacturing standard) would have no bearing on it’s advertising. If Lynn Perie could explain in writing and in detail the differences between cGTP and cGMP that would go a long way to clearing up that incorrect assertion. The differences are vast. See this FDA document for cGTP in 361 products: https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm285223.pdf
    I have seen no credible scientific data out of Liveyon c/w the FACT guidelines for identifying MSCs, despite Liveyon continuing to make that claim. These are fixed standards that require the presence and absence of specific flow cytometry markers, the ability of cells to adhere to plastic and form colonies, and then trilineage differentiation.
    As Don brings up and I would like to echo, Lynn is doing what we have seen Liveyon and many other companies do. Make a live stem cell claim on a 361 tissue which is not permitted. Double down on that claim by providing physicians information that looks credible on the surface, but doesn’t pass scientific muster. Finally, use terms like cGMP without any understanding of the standards followed by different labs or what they mean.


  9. Liveyon is selling product to doctors who are treating patients intravenously for everything from autism to MS. It’s all over Facebook. I assume they will claim these doctors “were not following the Liveyon protocol” when they eventually get caught. It’s a pretty convenient excuse. Don’t they ask doctors who are buying their product on a regular basis what they are treating with it? I would think they’d like to know if it is working or not. I would also think they would like to know if it is being used as a 351 drug instead of a 361 product (even though it is clearly 351 in all cases for reasons discussed above.) By the way, they also sell to chiropractors: https://www.ziprecruiter.com/c/LIVEYON/Job/1099-Medical-Sales-Representative-(-Stem-Cells-)/-in-Birmingham,AL?jobid=05f6e70d-2c4f8f09

    “We are seeking an aggressive sales rep who has worked in Healthcare sales previously and has relationships to capitalize on within the Pain Mgmt, Anti Aging, Chiropractic, Orthopedic or Regenerative Medicine space in order to introduce our product and or Stem Cell therapy to existing Medical clinics. This position is a 1099 opportunity with an unlimited income potential.

    This is a High Growth market that is absolutely exploding and will in fact be the future of Medicine. The opportunity is ground floor and will allow the successful candidates to not only be a part of this once in a lifetime opportunity, but allow them to piggy back on current income stream or have this become your primary income stream. There is no ceiling on income….”


  10. 351 and 361 designation is clear. Liveyon is not within protocol.

    However, I will say that people who point to the FDA as a ‘savior’ should recognize that it is not infallible nor even accurate in its assessments in all cases. It is the arbiter and the enforcer of what ‘we’ can and can’t do, but that does not mean that those judgments are the BEST thing for either medicine or patients. I am not advocating anarchy and I see extremely poor medical practice and snake oil claims daily. But don’t get caught up in conflating “FDA approval” with good medicine and/or good patient care.

    ‘Stemcell’ treatment will likely be a boon to future generations, but currently, we need to focus on the science. I see so much ‘junk’ being done that my biggest fear is not patient harm, but rather, irreparable harm to the field by bad or incompetent doctors perform sham procedures and getting poor results. I fear that the field could be giving itself such a major black eye, that it will be difficult to get away from the stigma.


  11. I have had two stem cell injections (for COPD). Both provided by Atlas Medical Center in Colorado Springs. Atlas states that Liveyon is their supplier, and that Liveyon’s standards are the highest in the industry. The results from the first injection were amazing. The morning after, I woke up feeling absolutely euphoric. My oxygen numbers were up and my lungs felt clearer and cleaner than before the treatment. After a few weeks that feeling subsides and of course, a booster is needed. The booster made me very sick however, and I felt as though it reversed any good that the first had accomplished. When I discussed the trouble with Atlas, I was told that flu-like symptoms are common with many patients (my symptoms were much worse than flu-like), but that other patients who had treatment at that time, had also complained – perhaps it was a bad batch, to which I inquired how Atlas was managing the negative results of a very expensive treatment. Of course, the doctor liaison would not commit to helping me, she did suggest I speak with Dr. Carlson (chiropractor), about the booster treatment. After meeting with him, I had decided not to return for further treatments. Although Dr took time to meet with me, he essentially waved off my concerns about the treatment and the cost of paying a lot of money for nothing.

    Since then, a friend of mine, whose lung capacity was at 16%, is now at 24% (she’s had three injections in 2018). Hearing that, I scheduled another appt w/ Atlas for one more treatment. I guess, hope springs eternal.

    Stem Cell therapy is unproven for long term, and apparently, patients need multiple treatments, which of course, makes the stem cell providers all very happy and very rich.


  12. The Liveyon Recall was in fact based on at least one case where I know for a fact that the patient received a stem cell injection into the hip joint which was saturated with e coli. I question how many other patients received cells the same batch.

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