You probably remember Liveyon. It’s a marketer of an “umbilical cord stem cell” product that was recently recalled by the FDA. The recall was due to adverse events that may have included E. coli contamination somewhere before it was injected into patients, some of whom apparently got sick.
Since it seemed like this recalled product was a major part of Liveyon’s business model, some wondered: could the company survive the recall? My sense at the time was that it would just find another source for some kind of “stem cell” materials to sell. One of its apparent leaders Lynne Pirie eventually said as much in the comments section of my post on the FDA recall.
It’s not entirely clear yet either who this new supplier is or what the product might be. Liveyon has a revamped website though focused on their new incarnation (see screenshot). It also says you can pay $5,000 to attend their “mastermind summit” meeting to learn more.
$5,000? What do you get?
The first topic item mentioned in regard to this mastermind thing is “building a seven to eight figure stem cell practice.”
Uh, what about helping patients in need? I don’t see that. It seems heavily focused on profit to me.
On another page I see patients mentioned, but just how to get more of them “in the door.” Also on that other page is “How to become the celebrity doctor in your city.”
All for the good of patients again, right?
The homepage highlights in bold font and all caps, “Featuring special guest trainer” Dave Vanhoose.” Who? I Googled Dave and it seems he’s a speaking coach amongst other things. In addition to Vanhoose, you can apparently also meet the “team of scientists” at Liveyon. I wonder who they are? What are their credentials?
The website has a new slogan too, “the pure feeling of healing”. That word “pure” may be key here given the potential contamination of the older product at some point. The slogan “the pure feeling of healing” doesn’t invoke a rigorous science-based medical firm to me.
How about you?
When I was a kid in the 70s sometimes I’d see a particularly over-the-top televangelist on TV while flipping through the channels. I could see them saying something like, “the pure feeling of healing,” but even as a kid I can’t imagine I would have wanted myself or a loved one to get a medical treatment having anything to do with such a slogan.
In the end, overall many questions remain about these kinds of birth tissue-related stem cell clinic firms and their suppliers. In related news that raises more concerns in this area, the FTC just took action on some “amniotic stem cell” clinics and their owner too.
More broadly, my advice to patients would be to steer clear of this kind of clinic and product. In my opinion it’s a big waste of money and there clearly are risks.
33 thoughts on “Stem cell clinic supplier Liveyon tries to regenerate itself after FDA recall”
Great post Paul.
1. Liveyon is a Marketing Company. It’s CMO Alan Graveck is an ex-DPM who lost his license in Arizona as a result of “unprofessional conduct”. He has zero formal training in Regen-Med and has never been published. Liveyon CEO, John Kosolcharoen, was arrested on healthcare fraud in 2016.
2. Liveyon does NOT distribute or provide “stem-cells”!! In fact, if you read their clinical support closely and do a little homework, you will understand the gimmick. Sadly, very few, if any, actually read the small print and/or care enough to dive into the details.
3. If ANYONE is walking into the door of a Chiro office and receiving any type of IV treatment, they need to address their much bigger problem which is the 3lb mass above their shoulders.
So what are they selling exactly?
“outfits”. Liveyon does not know any science. It is confusing that they say their stem cells come from Gentech, at the same time Liveyon is the one filling form for FDA and that too the form for dead cells. then they market their technique as alive cells? Also they gamma irradiate their cells, Hellooo?? Apart from all this, the bottom line is there is NO way any company, clinicians can get engraftment of any kind of so called stem cell they are transplanting (Stem Cell Bio 101). Dr. Z thank you for pointing to the 3lb mass which i’m assuming is just mass w/o grey matter, bc they dont even think How does a chiro fit into cells? and how or why are they not looking at whatever they are trained to look at
Can you explain to me how a nurse practitioner at a chiro clinic can perform stem cell injections (specifically from Invitrx) into the bloodstream in order to improve circulation and eliminate pain due to improper circulation if these stem cells are not approved by the FDA? And would there not need to be any monitoring or follow up with the patient after an injection like this to insure no reactions or infections, especially in a patient with an already compromised immune system?
It doesn’t make much sense, right? They shouldn’t be doing this stuff in my opinion. Did you get such a treatment? How much did they charge? How did you feel about the experience? Thanks, Paul
I want to know the same thing. How can nutritionists administer stem cells to my Mom desperate for anything that offers promise.
Can you email me please about the details of the nutritionist? knoepflerATucdavisDOTedu.
Do you know what kinds of stem cells were supposedly used?
Please watch the new movie exposing fraudulent amniotic and cord blood and exosomes being sold as if they contain living stem cells when they do not!
It is called “From Jail cell to stem cell- the next con for the ex-con” on Vimeo.
Also, they are Not FDA Approved, spread disease ( see the Florida Department of Health letter sent to physicians who purchased Liveyon), are Unsterile per the CDD/ FDA MMWR September 2018 and are not donor matched to the host causing GVHD.
Having confronted the CEO personally face-to-face, I could not get an answer as to where the material for the product actually is sourced.
The film is very well done and explains exactly how these stem cell scams are happening. It is a must see for anyone who has a body or stem cells!
Here is the link to the film on reelhouse:
Please visit Justia Trademarks and then type in Liveyon. The Liveyon LLC description in the middle, the second listing, states that they are using their
“ product “ For these purposes:
“Goods and ServicesStem cells for therapeutic and medical purposes
International Class005 – Pharmaceutical, veterinary and sanitary preparations; dietetic substances adapted for medical use, food for babies; plasters, materials for dressings; material for stopping teeth, dental wax; disinfectants; preparations for destroying vermin; fungicides, herbicides. – Pharmaceutical, veterinary and sanitary preparations; dietetic substances adapted for medical use, food for babies; plasters, materials for dressings; material for stopping teeth, dental wax; disinfectants; preparations for destroying vermin; fungicides, herbicides.
US Class Codes006, 018, 044, 046, 051, 052
Class Status Code6 – Active
Class Status Date2017-02-23
First Use Anywhere Date2017-01-01
First Use In Commerce Date2017-01-01
Current Trademark Owners
Party NameLIVEYON LLC“
Liveyon is still a 361 Registered company and is still calling their product “ stem cells,” even though the FDA/ CDC state that 361’s cannot contain any living stem cells. CBER as well as the new FDA document Paul posted explaining 351 FDA Approved Drugs vs 361 Registered HCT/P’s.
I don’t think Liveyon is a clinic, they distribute the stem cells. Yes, I agree with you about their seminar not being about patients. They are a company not a clinic, so, they do have to market like a company would.
Their goal is to supply the product to doctors, not be clinicians. One thing the writer leaves out is all the people that really feel they have been helped by the products. People that were living in severe daily pain, now out of pain. I guess until it happens to you, you can’t understand. One thing is for sure, Steroids are TOXIC to our body…Pain Pills,,,also toxic and addictive…These stem cell based products…seemingly untoxic..but, MAY put big Pharma out of work. The science IS there, now it’s time to test the science and the efficacy. You only do that by making Drs part of your team so that the reports come in from them. I tend to think there is a scientific hysteria going on regarding stem cell technology right now. What it really comes down to is this, it’s the patient’s decision to take the risk and the power really lies with them. With the govt now taking away pain meds from people that need them, it seems we are left with no choice but to take what appears to be the safest route.
It is sad to see that the true potential of regenerative medicine will diminish due to the false claims of these products and the clinics that choose to implement them. These products should be compared to PRP rather than Stem Cells, patients will suffer from this.
Bill – so you’re stating it’s hard for a DC to pass up an opportunity to commit fraud? It’s only enticing to those without a conscious, morals or any understanding of basic science. As long as your cool with deceiving the general public and committing a dangerous act, then I guess it may better than cracking backs. There is a reason why you see DC’s doing the lecture circuit and not MD’s.
The genie may never be put back in the bottle, but educating the consumer (paiteint) and exposing the con-artists is paramount in slowing this get rich quick gimmick down.
Btw – the majority of DC’s hire a 3rd party to come in a few hours 1-2 days a week to do the simple injection and they ( like the D.C.) posses zero background in the science. Furthermore, they are not using proper guidance. I’m unaware of any D.C. providing IV Therapy as you mention which is another level of serious concern.
I’m stating exactly what I said in my previous comment, no more and no less.
Is this you Bill?
I’ve talked to MANY patients who receive IV stem cells in D.C. offices. It’s prevelent. Even in small towns! Many are saying they’ve been helped. I’m not saying I agree with this by any means, but just like I told admin a few years ago MS patients were paying upwards of 100K to be in clinical trials, and was dismissed, this is happening! Talk to the patients! The patients have no idea these clinics are opporating in gray zones, outside of FDA regs, or that the off the shelf products they are being treated with could be contaminated as we’ve seen lately. FDA will not step up. The states are going to have to do it.
“Many are saying they’ve been helped. I’m not saying I agree with this by any means..” But you did say that. You said this on this blog several times. You said stem cells have helped many people and I asked for controlled clinically proof. Needless to say it was not presented. Looks like reality bites, eventually.
Dr. Z: you talked about consumer education, that’s what exactly I’m doing with http://www.thescrutinizer.org; However, the problem is those clinics/companies etc always have people or fake patients who claim they have made miraculous recovery. Its so hard to deny that for another patient. Secondly, for some reason right now no one wants to believe anyone who knows science/medicine and want good of the patient. After having a few discussions with diff patients, the one reason I gather is that the patients want to believe in a cure or something exists for them. While a scientist like myself or all of us here knows all that is a fraud but in patients’ eyes we are taking their hope away. But why even entertain a false hope and now i come to full circle bc companies like Liveyon make these flashy presentations that makes people believe them. I’ll post a convo from orthopoedic surgeons who claim the same management of pain, etc etc with MSCs, you would be surprised, it was on linkedin. the surgeon stated that the patient has to lie and say they are better otherwise they feel they look like a fool after spending all that money and getting nothing…..
This type of market is much bigger than Liveyon. There are others including Predictive Biotech, Invitrx, Stemell, and NeoCyte to name several. There are even private patient groups on Facebook promoting these products and negotiating discounts for members and/or their children. In the case of autism, at least one clinic offers these products at a discount for groups of 50 or more children.
This industry is growing faster than ever. It’s a pretty enticing proposition for practitioners. They can get $4K or $5K for a fast, simple IV injection. That’s pretty hard for a chiropractor to pass up when they are used to cracking backs for 50 bucks a pop. Yes, chiropractors are treating things like MS and autism now. It’s not chump change for doctors either. Just 10 patients per month can bring in half a million dollars a year or more.
The FDA is never going to put this genie back into the bottle.
@Bill, That sure sounds bad.
And groups of 50 children getting transplanted with who knows what?
I am more than willing to disclose all of the communications and recommendations I provided to Genetech with respect to compliance with FDA regulations in regards to this matter, as doing so does not appear to violate my contractual obligations.
Thanks for that insight, James. Apparently they unwisely didn’t listen to you. I have some questions, if you are able to answer.
Where do these kinds of companies in a general sense (not necessarily this particular one) obtain the birth-related materials needed for cell isolation? In the U.S. or outside? Do the mothers-to-be consent to its commercial use or just use in “research”? Do hospitals sell this material without the mother’s knowledge? Also, do the companies count the living cells? How do they know what is a “stem cell”?
Paul, I was not around long enough to find out where the cells were coming from. I was asked to reviewed a single order by Livyon for “MSC” and nucleated cells – I asked about supplier, tissue source and how the cells were qualified as “MSC” but got no response. It is an FDA requirement to procure materials from an approved supplier (in this case Liyvons responsibility as Genetech is their supplier) and I am certain Genetech was not making nucleated cells by any approved FDA protocol and lacked the basic infrastructure and required Quality Systems (approved procedures, test methods, storage, environmental monitoring, etc.). I know there were discussions to procure UCB units from Mexico as I helped write protocols for how they might be qualified as a supplier of material for research use only until proper Quality Systems were put in place and they could go for FDA approval. It’s just a shame most places don’t want to do it the right way – it would create such a competitive advantage.
I also wish people would do things the right way. I also still wonder about maternal consent for the use too.
Nice and much appreciated commentary in the new film, James!
well they don’t even know what a ‘homing signal’ means for stem cells. The consent form says homing signal means the stem cells go to injury site and may become what is needed. When ever I ask so how do those stem cells know what to become? like they can read your mind? secondly, why is this working only for companies who are trying to build their practices but not from actual stem cell biologists like us who provide data, proof, slides, and want a method to actually treat or manage a horrible disease. Another thing is of patients that why do they need to trust these clinics and not a scientist? moreover Dr Knoepfler i’m glad you have this blog and only if liveyon knew MSCs are not stem cells. How is this even happening in The USA?
Paul, I signed an employment letter as Director of Compliance with Genetech, the supplier of the Liveyon product under FDA scrutiny, in 2016. It was a pro bono assignment. I advised them at the time that what they proposed to do was valid only for products intended for research use only and could not be used in any human or clinical application and advised them what is required to manufacture human cells or tissues for clinical or therapeutic applications. Apparently, they did not heed my advice.
My family was was sold Liveyon by a DC and an MD who sell it by telling people that they are getting living stem cells. We were all sick after the MD and DC mixed our blood platelets with the Liveyon product, put them mixed together into syringes and injected the mix into our back, necks and hip and knee. Our eldest family member had 2 IVs and suffered a gut rupture, an amputation and a server leg and foot infection. We are all service connected disabled veterans looking for solutions. Please email us at email@example.com. You may find our story on a website we created to help others avoid the same mistakes.
Thank you for sharing.
More to the point, if they know how to build a 7-8 figure stem cell business why bother offering classes for 5K at all, you’ll make far more just doing the ‘stem cell business’ yourself. Unless part of the gimmick is to flood the market to further dilute the FDA’s resources? Truly scary.