What is a Full Body Stem Cell Makeover®?
A clinic in Utah has been advertising a “Full Body Stem Cell Makeover®.” So what in the world is this? How does it work? In my opinion, is it legit? Let’s dive in.
The Genesis of this Blog
As my readers know, I often write about what I experience daily. This blog began yesterday when a patient sent me an email asking about a Full Body Stem Cell Makeover®. I saw this advertised a few years back but never focused on it. However, when my patients begin asking about it, it’s time to get out a blog post that I can refer them to.
As I have said before, this type of reality test for the stem cell wild west takes lots of time. It’s Sunday morning, and I began this blog at 3:45 am, finishing it a little under four hours later. By the time I re-edit several times and get this on Linkedin, it could be 6 hours total.
What is the Full Body Stem Cell Makeover®?
A clinic in Utah run by a naturopath (i.e., not an MD/DO physician specialist) through social media states, “A Full Body Stem Cell Makeover® gives you a comprehensive upgrade to manage pain, prevent aging or rejuvenate your body.”
This is a video I found online:
From watching this video from before and after the point that our naturopath begins talking about the Full Body Stem Cell Makeover®, there are multiple inaccuracies that, as the first person on earth to use many of these stem cell technologies through precise imaged-guided injections, I can easily refute. In fact, so many that in order to keep this blog easy to read, I will only concentrate on the highlights. However, before that, let’s look at the areas of the body that are claimed to be injected with the patient under IV sedation:
- All of the spinal facet joints from the head to the sacrum
- The epidural space (levels not specified in this video, but it looks like cervical and lumbar interlaminar and caudal without contrast confirmation)
- SI Joints
- Big toe joints
- Facial skin
- In men, the penis, and in women, the vagina
So what is injected?
- Bone marrow concentrate
- VSELs isolated from blood and activated with a LASER
- Stem cells from fat
There is also a discussion in this video about “MSCs” from umbilical cord products sold here in the United States that’s worth mentioning.
The Issues with the Full Body Stem Cell Makeover®
Risk vs. Benefit
The most glaring issue is that based on what I can glean, most of these injections would be into joints that are normal on imaging and that don’t hurt. As my patients know, at our clinic, we always discuss the risk/benefit of performing a regenerative medicine procedure. Given the complication rate for these injections, deciding to use them must consider if that small risk is outweighed by the possible benefits. To make that decision, we need to be able to quantify both the risk and the benefits.
What are the risks? Our research team has published much of the world’s literature on the common risks behind autologous bone marrow and adipose injection procedures (1,2). Phillipe Hernoigou has also published some excellent papers in this area (13,14). So what are the risks?
- Peripheral Joint Infection-This risk is never zero. Based on what we’ve published to date and what we are readying for publication, this risk is in the range of 1 in 500 to 1 in 1,000.
- Deep Venous Thrombosis for Knee BMC Injections-This risk, based on our published paper, is 1 in 639 cases.
- Spinal Procedure Infection Risk-Epidurals 1 in 769 cases, Facet Injections-1 in 1,666 cases (3) [For corticosteroid injections].
So what is the risk of injecting 48 facet joints, multiple epidurals, 16 peripheral and SI joints, and the face, scalp, and genitals simultaneously? That’s never been studied nor published, nor has this naturopath published the risks of this procedure in any journal I can find. My best guess is that the risk is far higher as an aggregate than those quoted above for the individual procedures.
What’s the risk of injecting totally normal joints with these autologous orthobiologics? Nobody knows at this point, as all of the research published to date has been in joints with arthritis and pain that cause some level of disability. What are the benefits? Also unknown.
In conclusion, IMHO, we don’t know enough about the risk and benefit here to allow a patient to make an informed decision.
The Video Doesn’t Show What’s Advertised
The video of the injections allows us to see whether what’s advertised is what’s being done. While there are many issues I noted, let’s focus on just one so that I can dive deep into that claim versus the reality. The naturopath states, “Then we do the facet joints at every level from the base of the skull down to the tailbone on both sides…”
Let’s begin with what is a real facet injection. The US National Library of Medicine defines a facet injection as involving the placement of a needle into the facet joint, which is then confirmed by contrast (4)., Here’s how they describe that procedure:
“Under image guidance, a 3.5-inch (5-inch for patients with obesity) 22 to 25 gauge spinal needle will be advanced to the facet joint, and a contrast medium (0.2 to 0.5 mL) will be injected. Confirmation of intraarticular access is seen on imaging with the formation of a linear streak between articular surfaces and the presence of the medium in either or both of the subcapsular pockets.”
That definition is also used by the major medical societies that teach these procedures, like SIS and ASIPP.
So did the naturopath inject all 48 facet joints using this standard-of-care technique? Let’s first look at the needles used:
The needles in the neck (shown above) and those placed into the thoracic and lumbar areas are: 1. not the 3.5-5 inch needles described above, 2. they are placed at the wrong angles to reach the facet joint, and 3. there is no contrast confirmation used. So what’s happening if the procedure shown doesn’t meet the minimum standard definition of a facet injection? This is actually a Hackett prolotherapy technique where the needle is placed using an x-ray in the general area of the facet joint and lamina without any confirmation that the needle is, in fact, inside the facet joint. Hence claiming that the facets are being injected without ever being able to confirm that this is what happened is a big stretch.
After performing tens of thousands of actual contrast-confirmed facet joint injections and teaching many fellows how to perform them using c-arm fluoroscopy, how long would it take a novice vs. an expert to inject all 48 facet joints using a technique that will document that they are actually inside each joint? For the 14 facet joints in the neck, a novice wouldn’t be able to inject the top two levels, but for C2-C7 facets, likely 30-40 minutes. An expert could cut that time in half. For the lumbar spine, those times are similar. However, thoracic facets using the real facet injection technique are tough, with many practitioners avoiding them altogether. So the novice would never attempt those 24 joints, but even for an expert, it could take about 2 hours.
So that’s three hours for an expert to inject every spinal facet joint with contrast confirmation of every joint. Using a Hackett technique with C-arm fluoroscopy (as shown in the video), this could be done by a novice in about 20 minutes. See the difference? One expert and standard of care technique painstakingly injects the facets and confirms that each one has, in fact, been injected. The other shotgun technique being used here doesn’t attempt to determine if the facet was injected, nor is it likely that by using this lesser technique, many of the facets ever received any stem cells.
The claim is made here that VSELS from blood are being injected. What are those? VSEL stands for “Very Small Embryonic Like” stem cell. We looked into this many years ago with a company that claimed to have a simple way to activate these cells. However, in 2013 the grandfather of embryonic stem cells published a widely regarded paper that refuted that these cells exist in the first place (5). The naturopath claims that a LASER can activate these cells, which seems to be based on a single non-peer-reviewed paper (6). In addition, unlike PRP, which has dozens of RCTs showing efficacy in treating knee osteoarthritis and tendon injuries, there isn’t a single clinical RCT I can find showing that even if VSELs did exist, they would help arthritic joints.
Umbilical Cord MSCs
Our naturopath claims to be using mesenchymal stem cells (MSCs) from umbilical cords. However, our published research in the world’s top-ranked orthopedic journal showed that none of these products have viable and functional MSCs (7).
Where’s the Research on the Full Body Stem Cell Makeover®?
I found no citations listed in the US National Library of Medicine published by this naturopath. Certainly, nothing published on the safety and efficacy of the Full Body Stem Cell Makeover®.Join us for a free Regenexx webinar.
So we have a procedure that injects most of the joints in the human body, including normal joints that don’t hurt, face, scalp, and genitals. The actual procedural techniques shown don’t meet the minimum published requirements for what’s advertised. In other words, when it comes to 48 of the joint injections, the technique shown is incapable of documenting placement where the provider claims the cells are being placed. On what’s injected, one of the ingredients called VSELs has been shown by one of the best scientists on earth not to exist. Even if they did exist, they haven’t been shown to help arthritic pain. Finally, I can find no published data on the safety and efficacy of this technique.
The Practical Realities of this Type of Procedure
The biggest issue with injecting 56 human joints, several parts of the spine into the epidural space, and other areas with autologous orthobiologics is dose. For example, let’s take just PRP and Bone Marrow Concentrate.
For PRP, our published research has shown that for older patients, higher doses work better (8). In our clinic, for a late middle-aged person, based on that research, we would use 14X concentrated PRP in each of these joints. For major joints, we would inject 3 ml; for smaller peripheral joints, 1-2 ml; for facets, about 1/2 to 1 ml. So that’s 12 ml for hips and knees, 12 ml for shoulder/elbows/ankles/big toes, and for 48 facet and SI joints, about 32 ml. So that’s 56 ml of 14X PRP. How much blood would that take to prepare? To get there, we take 56×14=784 ml and double that for 1,568 ml and then adjust that for 80-90% platelet recovery, so about 1.8 liters of blood. The US National Library of Medicine states that patients shouldn’t donate more than 13% of their blood volume (9). For a 90 kg male, that would be 700 ml +/- 10%. That would be adjusted down for patients that weigh less or where anemia is present.
So we need 1,800 ml of blood to get IMHO an efficacious PRP procedure, but even in a 200-pound man, we can only take much less than half that much. In a 100-pound woman, we’re off by much more than a liter. If that woman is anemic, we can even take less.
Now let’s talk bone marrow. Our published data shows clearly that to treat just knee arthritis, the total nucleated cell or MSC dose as measured by CFU-f matters (10,11). Practically, getting to this minimum effective dose just for the knee requires about 60-120 ml of bone marrow aspirate taken in a highly detailed, small aliquot manner. So treating even 3-4 joints with bone marrow concentrate would be impossible in most patients, especially since you begin to compound your blood loss problem described above by taking more marrow. For example, if you’ve already taken the maximum amount of blood, then taking bone marrow, which is where some of the blood cells get produced, compounds the anemia problem. Why? Every day that marrow is responsible for producing 200 billion red cells, 10 billion white cells, and 400 billion platelets (12). So when you take marrow, you’re not only removing red blood cells causing anemia but also the cells that make red blood cells.
If you really wanted to treat many different areas, what are your options? First, we treat multiple areas of the spine (with real facet injections) and several arthritic peripheral joints daily. We can do that by using various combinations of PRP or BMC, or other autologous products. However, treating all of these areas described in the Full Body Stem Cell Makeover® with stem cells would require the type of culture expansion we use in Grand Cayman and that we pioneered beginning in 2005. However, please note, we DO NOT TREAT NORMAL JOINTS, as the risk-benefit ratio is inappropriate IMHO.
The upshot? Would I lie on the table and let someone inject me as described in the Full Body Stem Cell Makeover®? Nope. Why? Because the risk-benefit ratio is upside down for injecting normal joints with the current data available. In addition, for this procedure, there are all sorts of issues, like which structures are actually being injected, getting enough cells to make a go of injecting almost every joint in the body, and whether VSELs exist at all. Not to mention the idea that umbilical cord tissue products have living and functional mesenchymal stem cells, which is fiction based on our published research.
(1) Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30. Erratum in: Int Orthop. 2018 Jan;42(1):223. PMID: 27026621.
(2) Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30. Erratum in: Int Orthop. 2018 Jan;42(1):223. PMID: 27026621.
(3) Santiago K, Cheng J, Jivanelli B, Lutz G. Infections Following Interventional Spine Procedures: A Systematic Review. Pain Physician. 2021 Mar;24(2):101-116. PMID: 33740341.
(4) National Library of Medicine. Stat Pearls. Facet Injection. https://www.ncbi.nlm.nih.gov/books/NBK572125/ Accessed 1/8/23
(5) Miyanishi M, Mori Y, Seita J, Chen JY, Karten S, Chan CK, Nakauchi H, Weissman IL. Do pluripotent stem cells exist in adult mice as very small embryonic stem cells? Stem Cell Reports. 2013 Jul 24;1(2):198-208. doi: 10.1016/j.stemcr.2013.07.001. PMID: 24052953; PMCID: PMC3757755.
(6) Hollands et al. The action of modulated laser light on Human Very Small Embryonic-Like (hVSEL) stem cells in Platelet Rich Plasma (PRP). CellR4 2020; 8: e2990
(7) Berger DR, Centeno CJ, Kisiday JD, McIlwraith CW, Steinmetz NJ. Colony Forming Potential and Protein Composition of Commercial Umbilical Cord Allograft Products in Comparison With Autologous Orthobiologics. Am J Sports Med. 2021 Oct;49(12):3404-3413. doi: 10.1177/03635465211031275. Epub 2021 Aug 16. PMID: 34398643.
(8) Berger DR, Centeno CJ, Steinmetz NJ. Platelet lysates from aged donors promote human tenocyte proliferation and migration in a concentration-dependent manner. Bone Joint Res. 2019 Feb 2;8(1):32-40. doi: 10.1302/2046-3758.81.BJR-2018-0164.R1. PMID: 30800297; PMCID: PMC6359887.
(9) Blood Donor Selection: Guidelines on Assessing Donor Suitability for Blood Donation. Geneva: World Health Organization; 2012. 4, General donor assessment. Available from: https://www.ncbi.nlm.nih.gov/books/NBK138219/
(10) Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z. PMID: 26385099; PMCID: PMC4575428.
(11) Centeno CJ, Berger DR, Money BT, Dodson E, Urbanek CW, Steinmetz NJ. Percutaneous autologous bone marrow concentrate for knee osteoarthritis: patient-reported outcomes and progenitor cell content. Int Orthop. 2022 Oct;46(10):2219-2228. doi: 10.1007/s00264-022-05524-9. Epub 2022 Aug 6. PMID: 35932306; PMCID: PMC9492580.
(12) Cooper B. The origins of bone marrow as the seedbed of our blood: from antiquity to the time of Osler. Proc (Bayl Univ Med Cent). 2011 Apr;24(2):115-8. doi: 10.1080/08998280.2011.11928697. PMID: 21566758; PMCID: PMC3069519.
(13) Hernigou P, Flouzat Lachaniette CH, Delambre J, Chevallier N, Rouard H. Regenerative therapy with mesenchymal stem cells at the site of malignant primary bone tumour resection: what are the risks of early or late local recurrence? Int Orthop. 2014 Sep;38(9):1825-35. doi: 10.1007/s00264-014-2384-0. Epub 2014 Jun 7. PMID: 24906983.
(14) Hernigou P, Homma Y, Flouzat-Lachaniette CH, Poignard A, Chevallier N, Rouard H. Cancer risk is not increased in patients treated for orthopaedic diseases with autologous bone marrow cell concentrate. J Bone Joint Surg Am. 2013 Dec 18;95(24):2215-21. doi: 10.2106/JBJS.M.00261. PMID: 24352775.