If you read this blog, you know I get sent stuff all the time. I’ll usually write about the craziest stuff I get sent and this morning that’s an at-home IV Umbilical Cord “Stem Cell” business called Living Well Regenerative Health in Alexandria, Virginia. Let’s dive in.
The Umbilical Cord “Stem Cell” Scam
I’ve written many times about how the amniotic and umbilical cord products that clinics can buy have no live and functional stem cells. This has been studied by numerous labs and all found the same thing (1-3). CSU was the fourth lab that exclusively focused on umbilical cord blood products and also found no living stem cells. This and other issues led to a public FDA Warning about umbilical cord blood products, but despite these facts, we still see many vendors and physicians getting involved in this bait and switch fraud.
Living Well Regenerative Health
I was recently sent a copy of a recruiting e-mail that was soliciting RN’s in the southeast to provide home infusions of umbilical cord “stem cells”. The company was Living Well Regenerative Health and this is what was in the brochure that was sent:
- A Telemedicine “visit” in your own home without a physician’s examination
- The RN’s will treat you for “Pain, Inflammation, Degeneration, and Immune Dysfunction”.
- “With as little as one therapy, your body can begin to renew itself from the inside out”
- “Human Umbilical Cord Blood (Stem Cell) Therapy can renew cells, regenerate new tissue, and help restore your health”
- “Schedule Your In-Home Therapy Appointment With A Living Well Home IV Nurse”
- “Remote Follow-Up Visits at 1, 3, and 6 Mos”
- “It’s Time to Live Younger and Stronger for Longer!”
Living Well Regenerative Health also claims that the products it uses are not drugs and that research has shown that this therapy can reduce pain, inflammation, cellular degeneration, and immune dysfunction.
Is any of this verifiably true? Nope. Let’s dive deeper.
Kyon Hood, M.D.
The email that was sent to local RN’s was signed by Kyon Hood, M.D. Who’s that? He’s a pediatrician in Fredricksburg, Virginia who graduated from a Carribean Medical School. He is also the president of a company called “Teledoc Physicians” and was the medical director of a pediatric urgent care clinic called “PedsExpress”. Now apparently he’s the ringleader of Living Well Regenerative Health.
Of note, before attending the Carribean Medical School (St Georges in Grenada) Dr. Hood’s Linkedin profile states that he got a psychology degree from “Harvard Extension School”. So how did a kid from Harvard end up at a Carribean Medical School? Let’s review.
It turns out that the “Harvard Extension School” is just an online degree and while associated with the Harvard brand, is not the same as going to “Harvard”. This is what I found online:
- “To begin with, a Harvard Extension Degree is not the equivalent of a Harvard College degree. While it is associated with the Harvard “brand” the coursework is designed primarily for people who are more casual in their pursuit of a formal education. “
- “Your professors at the Extension School are not likely to be regular Harvard University teaching staff. This means that while you do get to carry the Harvard brand, the coursework is not as rigorous as the University. “
OK, now this makes more sense. Dr. Hood got an online psychology degree using the Harvard Brand but never attended Harvard College as an accepted undergraduate.
So what is a pediatrician doing offering RN delivered at home IV infusions of umbilical cord blood to the elderly and claiming that it will help them “Live Younger and Longer for Longer”?
Umbilical Cord Blood Products are Dangerous Until Proven Otherwise
Most patients and physicians believe that since the umbilical cord blood products on the market carry a 361 FDA registration that this means that the agency has looked at the safety and efficacy of these products. Regrettably, that’s not true. Instead, this is a free 45-minute online registration where the FDA doesn’t review the product before being sold.
This tissue registration pathway has turned out to be a lucrative “loophole” for companies selling umbilical cord blood and tissue. However, with a recent public warning, it looks like the FDA has begun to start the process of closing this regulatory gap. See my link above to the recent FDA Warning on umbilical cord products.
Why do I say that umbilical cord (UCB) products are potentially dangerous? First, they require HLA matching. This means that you need to know which cell markers the patient has and which the donor had to avoid an awful disease called GVHD (4-6). That’s a chronic rejection reaction to foreign cells. Having just met a patient on long term high dose oral steroids for Graft vs. Host Disease (GVHD), this is one you don’t want to get. At the very least it’s a nasty chronic rash and at the most, it’s organ failure.
The problem with UBC products and GVHD is that unlike everyone else in the world that uses UCB, the alternative medicine and anti-aging crowd has convinced itself that patients don’t need HLA matching. Why? This seems to be due to a misconception that what they’re buying is a bottle of immune-privileged stem cells that can actively evade the host’s immune system when in fact what they’re buying is a bottle of dead cells of many types, many of which can provoke a serious immune reaction.
Then we have the problems with contaminated umbilical cord blood products that the CDC is tracking. We’ve seen infected umbilical cord blood products put more than a dozen people in ICUs all over the country. So there’s that little picadillo.
Do we have any evidence that Living Well Regenerative Health plans to HLA match these elderly patients and the umbilical cord blood units being provided? None that I can find.
Training Nurses How to Infuse IV Umbilical Cord Blood
Dr. Hood’s email explains that he will use a 30-minute online training session to train his nurses on what to do. He does state that additional training phone calls may be needed. What will these nurses be injecting? You can’t make that one up.
I have previously blogged on an umbilical cord product vendor called New Life when I covered how Dr. Singer, a chiropractic practice consultant, was pitching that chiros add umbilical cord “stem cells” to their practices. That’s what Dr. Hood relays that his nurses will be injecting, so let’s dig in.
New Life is a company that distributes the products of others. I spoke to their CEO Viki Mansavage, who admitted that their products likely didn’t have many live and functional stem cells. The company quickly removed any references to stem cells on their website after my conversation with Ms. Mansavage. Hence I can find no references to stem cells on the existing New Life website.
What did I find on the NewLife website? I found this, “Our regenerative medicine treatments, including RENyTe, are only available to physicians who have been carefully vetted and adhere to strict protocols, ensuring our patients receive the same quality of care regardless of where they receive our RENyTe treatment.” Huh? So how does that jive with the Living Well Regenerative Health plan where we have a pediatrician performing a remote online consultation with the elderly and then sending a nurse to give an IV infusion?
Turning Back the Hands of Time
Is there any data that dead umbilical cord blood cells (New Life) will reverse the effects of aging? Nope. Maybe a single study showing that this product can dramatically reduce the biomarkers for aging? Nope. Then what are Dr. Hood’s claims based on? Your guess is as good as mine.
The upshot? So we have a pediatrician who wants to hire nurses to deliver non-HLA matched umbilical cord blood to the elderly to treat a panoply of things including aging itself, all after an online assessment without a physician’s exam. As I always say, you can’t make this stuff up!
(1) Berger D, Lyons N, Steinmetz, N. In Vitro Evaluation of Injectable, Placental Tissue-Derived Products for Interventional Orthopedics. Interventional Orthopedics Foundation Annual Meeting. Denver, 2015. https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf
(2) Becktell L, Matuska A, Hon S, Delco M, Cole B, Fortier L. Proteomic analysis and cell viability of nine amnion-derived biologics. Orthopedic Research Society Annual Meeting, New Orleans, 2018. https://app.box.com/s/vcx7uw17gupg9ki06i57lno1tbjmzwaf
(3) Panero, A, Hirahara, A., Andersen, W, Rothenberg J, Fierro, F. Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine, 2019 47(5), 1230–1235. https://doi.org/10.1177/0363546519829034
(4) Holtan SG, Pasquini M, Weisdorf DJ. Acute graft-versus-host disease: a bench-to-bedside update. Blood Jul 2014, 124 (3) 363-373; DOI: 10.1182/blood-2014-01-514786
(5) Lee SJ. Classification systems for chronic graft-versus-host disease. Blood Jan 2017, 129 (1) 30-37; DOI: 10.1182/blood-2016-07-686642
(6) Socié G, Ritz J. Current issues in chronic graft-versus-host disease. Blood Jul 2014, 124 (3) 374-384; DOI: 10.1182/blood-2014-01-514752