I love the show Flip or Flop. That’s the one where the young couple fixes up homes. He’s the ultimate pragmatist numbers guy, and she’s the creative designer who always wants to spend more than they can afford. So I was dumbfounded when Tarek El Moussa, the male costar, reported yesterday on Instagram that he had a low-back stem cell treatment that consisted of an IV? Even crazier is that his Instagram feed contains a picture of the two doctors who performed the procedure, none other than the two who were at the blunt end of a request by the FDA for a federal injunction yesterday. You can’t make this stuff up…
The Stem Cell Wild West
Two days ago the FDA filed a request for a federal injunction against two fat stem cell, IV cure-all clinics. One was two hours east of Los Angeles, where Tarek was treated. That clinic was targeted because it was using or had plans to use a smallpox vaccine mixed with fat stem cells to treat cancer patients. In addition, the government filed to enjoin all stem cell use by anyone on the Cell Surgical Network.
The two physician leaders in the Cell Surgical Network are a plastic surgeon and a urologist. Despite neither of these physicians having any advanced knowledge of the spine, they appeared on Tarek’s Instagram feed of his procedure, posted yesterday morning (second image in the feed). I posted this picture below:
The doctor on the far left is Mark Berman and on the far right is Eliott Lander. Given that they received the lawsuit requesting a federal injunction two days ago in which the government sought to stop the pair from using SVF to treat all patients, was this procedure performed before or after they were notified?
In addition, we know from the FDA documents filed in court yesterday that taking someone’s fat, processing it to get the cells out (this is called SVF for stromal vascular fraction), and injecting that IV, represents according to to the FDA, an illegal drug product that requires full FDA approval per medical indication. Just one medical indication is injecting SVF intravenously to treat low-back pain. No such FDA approval exists, so based on FDA’s reasoning, Tarek had an illegal drug therapy.
What Happens When You Inject Stem Cells IV?
Injecting mesenchymal stem cells IV is a great way to treat your lungs. Meaning, based on several studies, 97% of the cells will get stuck in the lungs. See my video below for the scientific reference for that phenomenon:
So why inject stem cells IV to treat a low back? Why not just find the structure that’s damaged in the low back and inject them there using precise imaging guidance? Only a select group of physicians understands how to place cells in the specific low-back structures using imaging guidance. Hence, if you’re a clinic with little expertise, you can easily find someone to start an IV.
It Gets Worse, Much Worse
Based on animal studies where cells are tracked, ninety-seven percent of the cells that were injected IV into Tarek’s arm are now sitting in his lungs. He thinks he was injected with a million MSCs, and that may be right, depending on the amount of fat they took, but that number is likely a vast overestimate. If that’s true, then only around 33,000 made it out of the pulmonary first pass. That number would then be distributed throughout his body. Hence, only a very tiny percentage of that number would end up in blood vessels in the spine.
Even worse for Tarek is that most musculoskeletal injuries are avascular, or poorly vascular. Take, for example, his low-back disc. Let’s say he tore some of the outer covering of the low-back disc called the annulus and painful nerves have taken up residence there. This area is almost certainly avascular, meaning it has no or poor blood supply. Hence, the likelihood that any of these stem cells make it there are slim and none and “Slim’s on vacation in Texas.”
Far, Far Worse
Far worse is that this is a patient with a history of cancer in remission. We know that MSCs, when added to tumors, make those lesions bigger. Tumors are VERY vascular. Hence, if Tarek has any small lesions in his body brewing, injecting stem cells IV is the last thing you want to do. In fact, to date, we have no safety data focused on IV SVF injected in patients who have had prior tumors.
Could This Work a Bit?
Because MSCs can pump out anti-inflammatory cytokines, it’s possible that a procedure like this could reduce systemic inflammation (whole-body swelling). It’s also possible that this may tone down the pain a bit. It’s even possible that some of the cells may egress from the lungs at some point. However, based on my extensive experience in spinal low back orthobiologic injections, whatever is damaged in Tarek’s back will still be damaged.
What Should Have Been Done?
First, fat stem cells that the FDA considers an illegal drug product should never have been used. Second, a careful assessment of Tarek’s imaging as well as a thorough hands-on exam should have been used to ID what was wrong and then decisions made about where to target legal stem cell injections. Then precise imaging guidance (fluoroscopy and/or ultrasound) would be used to place the cells at those exact spots. Why settle for a few stem cells that might make their way from your arm to your back when you can have huge quantities placed right at that spot?
The upshot? It’s hard to make this stuff up! If someone tells you they want to inject stem cells in your vein and that these cells will magically find their way to your injured low back, make sure they haven’t been enjoying some of California’s legal weed before you pay them big bucks. While stem cells can “home” (meaning find injured tissue), based on the published literature, it’s very, very unlikely that more than a few stem cells would ever end up in the part of your damaged low back that needs it the most! Finally, what were Berman and Lander doing injecting (or being involved with an injection of) a cancer survivor with stem cells that the FDA deems an illegally produced drug product in the midst of a lawsuit where the government is requesting an injunction against all use of this product? Your guess is as good as mine…