A Fake Stem Cell Injection at Your Home? Welcome to Biologics Health

I often use the phrase, “You can’t make this stuff up” when referring to the stem cell wild west. This week on Facebook a patient recounted a bizarre incident where she was injected with fake stem cells in her own home. So let’s dig into this strange and disturbing story.

The Patient’s Story…

We saw this initial post on Facebook:

“Be wary on stem cell treatments! I had stem cell therapy injection on February 29, 2020. 5 days later I was in the hospital for 3 days with a huge DVT blood clot in my left leg that had to be surgically removed. Now 3 1/2 months later still dealing with a swollen left leg and small blood clots. The right hip pain that the injection was to heal is also still causing lots of pain. Lost self esteem at making a poor decision, much disappointment at not only still having hip pain but also added pain most likely caused by the stem cells and $9000 poorer!”

This intrigued us so we asked this patient for more of the story:

“We were invited to a meal at a local restaurant through a flyer we had gotten in the mail. Mainly just went for information since I have been suffering so much from sciatic pain in my right hip. A sales rep came to our house the next day and gave all kinds of promises of getting rid of the pain in my hip, renewed energy, etc. He said the stem cells would be able to detect inflammation in my body and as they regenerated, would work on healing those areas also. Stupidly, I signed up (pain makes on make dumb decisions). Put $9000 on my CC. They have a “white glove discount” given when they come to your house instead of you going to their clinic in Cleveland, Ohio. Plus, if you go to the clinic, they charge another $265. A nurse practitioner comes to the house to give the injection. I have been in a lot of contact with them and they know I am still in pain and very upset with them. They just keep telling me I need to give it time, like I really have a choice. If I could have a do over, I certainly would. The stem cells come from amniotic tissue in the cords of healthy newborn babies. The company supplying my stem cells was Invitrx (sp). No matching is done for blood type or anything else. No only thing done to decide if I was a good candidate was just that I was in pain and gullible.”

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What Went Wrong?

This case has so many different facets that are obviously wrong, but let’s dive into a few:

Timeshare Sales

If you go to a dinner seminar based on a mailer and it’s a high-pressure sales event, please leave. If you’re getting a lecture by a doctor, it should be educational and not a sales event. “Act Now!” discounts aren’t in the medical lexicon.

Your Home is NOT the Place for these Complex Procedures

This is what a procedure room for PRP or stem cell injections looks like (above). Note that you have none of this equipment is in your home. In addition, your home is not set up as a sterile environment. Enough said.

Blind Injection

This woman was injected without any imaging guidance. It’s not possible to inject a hip joint without a huge error rate (i.e. never injecting inside the joint) without imaging guidance. In addition, in my opinion, for all we know, the provider injected into her leg vein causing the clot and not into the hip joint. Or perhaps the lack of activity due to the pain caused by the injection caused the clot. Either way, not using imaging guidance is below the standard of care set by physician organizations like the Interventional Orthobiologics Foundation.

Not a Doctor

She wasn’t injected by a trained specialist in Interventional Orthobiologics, but instead by a “mid-level” or a provider who is not a physician. In my experience, this is common with many fake “stem cell” outfits as this saves the clinic owners loads of cash and boosts profits. Why? the average mid-level makes about 1/3 to 1/4 of a properly trained specialist physician in this area. Hence, this is a serious concern.

Not Stem Cells

The patient never got injected with any stem cells as the birth tissues used by these clinics contain no living stem cells (1-3). Hence, the fraud began the moment the presenter in the seminar told her and everyone else that they offered stem cell injections. To learn more, watch my video below:

Who Is Biologics Health?

The patient states that the company that came to her home was Biologics Health. I’ve blogged before on the chiropractor involved with this company whose name is Scott Gray. Scott was the CEO of a company called “Stem Cell One” and “Gray Marketing Enterprises”. What is “Stem Cell One”? A chiropractic clinic that bills itself as “Leading Umbilical Stem Cell Therapy in Marion, Ohio”!  Now that you know from the research above that commercially available umbilical cord stem cell preps like those used by “Stem Cell” One have no live stem cells, you can see that just by making this claim on a public website, in my opinion, Scott Gray is committing consumer fraud.

The company website lists 4 doctors associated with the group. This quartet of physicians somehow covers 19 states? Not sure how that one is even remotely possible. They have 30 mid-levels (i.e. NOT a DOCTOR) listed. Almost all of the research listed on the website has nothing to do with the products the group offers and NONE of it is published by anyone in their group.

What Was Injected into this Patient?

The patient states that she was injected with a product from Invitx. First, as discussed above, based on the existing research, she wasn’t injected with any live and functional stem cells. Second, the Invitrx site as of today states that their products are “For Research Use Only”. So was this woman part of a formal clinical trial?  Nope. Third, Invitrx received a big FDA WARNING letter in March of this year that was really awful. The FDA investigators that visited the company found:

  • Infected donors
  • Inadequate screening of donors
  • Patient reactions to the product
  • Sterility failures

So was the stuff injected into the vicinity of this patient’s hip contaminated?  Did it have unidentified viruses?  Did it cause a massive adverse tissue reaction?  Given that Invitrix shipped these contaminated products to clinics, we may never really know.

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$9,000?

This patient was billed nine grand for this procedure. The bizarre thing here is that to have this procedure performed in a big procedure room with all of the needed equipment to guide the injection by a specialist physician and with real stem cells would have likely cost this woman LESS THAN $9,000.  So to have this procedure performed in her home by a mid-level provider without guidance and without actual stem cells performed for that price is not a good value. So please do your homework on what you’re getting for the price quoted!

The upshot?  Please do not let anyone come to your home to perform a “stem cell” procedure!  Also, please review the red flags I have identified above, as there are serious concerns with about 99% of what’s advertised as a “stem cell procedure”, even when those procedures are performed in clinics!  Stay safe out there!

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References:

(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

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

If you have questions or comments about this blog post, please email us at info@regenexx.com

NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

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