This will be my third blog this week about the crazy amniotic and umbilical cord fake stem cell marketplace and the medical treatment scams it launches. Why devote three blogs to this subject? Because this week likely marked a turning point in these cases of treatment fraud. This morning I would like to highlight how scams often get perpetuated by people who should know better, but who don't know what they don't know. I'll do this by dropping the temperature in a stadium by 100 degrees. Let me explain.
The Fake Stem Cell Marketplace
I won't belabor the point here, other than to remind new readers that clinics that advertise amniotic or umbilical cord "stem cell" treatments are really offering dead cells. This is, of course, the opposite of their advertising where they claim to be injecting tens of thousands to millions of young stem cells and charging big bucks to do so. If this is news to you, I have two short videos that will get you quickly up to speed. One I did about amniotic stem cell therapy where I discuss our research results showing that these are dead cell treatments, and the other by Cornell professor Lisa Fortier that also found the same thing. First our video:
Next up is a small one-minute piece of a larger podcast interview with Dr. Fortier:
The Big FDA and CDC Crackdown on Fake Amnion and Umbilical Cord Stem Cell Treatments
This week, the FDA sent a letter to providers manufacturing and using these fake amnion and umbilical cord therapies. They focused in their general public statement on making an example of one company that was rebranding umbilical cord tissue, called Liveyon. However, the FDA letter states that the agency will be sending out many letters to manufacturers of these tissues as well as providers who are using them to treat a myriad of illnesses.
The Statement That Started Today's Blog
Now let's look at an example of how not knowing what you don't know causes these scams to be perpetuated. This week, on the Liveyon blog we published, we got this comment posted by a sales rep for another company that is advertising a stem cell therapy:
"Agree. Not a fan of Liveyon. Some physicians use it with PRP and say they are getting results but it could be the PRP doing the work. Cord Blood is supposed to be used for blood indications only, imo, not joints. There are viable cells in some other brands carefully manufactured and a special freezing process. They are also not centrifuged and are high in MSCs. One has been tested after being left out for two hours and still had 24% viable cells, high in MSCs, growth factors, collagens, miRNA, exosomes, secretomes etc. The patient results have been phenomenal from the treatments using this other brand. "
To someone who actually knows what he or she is doing with regard to the science in this area, this is so silly on so many levels. However, the problem is 99% of sales reps and medical providers don't have the education needed to dissect this statement and see how crazy it is. So let's dive into it this morning.
Viability means how many cells survive. This is commonly reported in products that are frozen. As a physician who has been using cryopreserved mesenchymal stem cells for 13 years, I zeroed in on one number above, and the statement became instantly ridiculous. That was "24%." Why?
At first blush, you would think that if you began with a high number of stem cells in this product and about one-quarter survived at two hours, you would still have many functional stem cells. While that makes common sense to the uneducated, in order to understand why that number is the cellular kiss of death, let's unpack how cryopreservation works.
Cryopreservation means freezing. Freezing and thawing cells is a dangerous and dicey thing for cells unless it's done just right. The big enemy is ice crystals, which will act like large spears slicing and dicing cell membranes and killing the cells. The second thing that can destroy cells is temperature shock. Cells live in a very controlled world when it comes to what they are exposed to and the temperature at which they operate. Take your own body as a simple example. Your core temperature is 98 F (37 C). If that temperature goes up by just 10 degrees (or about 10%) to say 108 F, you won't last the night as an adult. Why? The enzymes, proteins, and other chemicals that run your cells will get fried.
Freezing and Thawing Cells
In order to make sure cells don't get killed by ice crystals, you can use a special chemical called DMSO. This will reduce the number that perishes in the process. However, on the other side of that equation, thawing the cells, you have to be very careful to avoid temperature shock. That's why cells are thawed using a controlled-rate environment where the temperature is changed very slowly. In addition, they are placed into a recovery culture for a few days where they can get over the small amounts of damage that happen even during controlled-rate thawing.
If you do all of this correctly, you can expect viability rates of over 90%. However, realize that this is after controlled-rate thawing and then several days in culture to recover the cells from the shock of a 200–300 degree F temperature change. This is in STARK contrast to how medical providers warm samples of amnio tissue or cord blood. They take these vials and shock thaw them (warm them up several hundred degrees in minutes).
In addition, realize that the final viability rate is also a window into the health of your cells. Meaning that if it drops into the 80s, your cells are likely not that healthy. If it drops further into the 70s, then your cells are likely damaged. Why?
The Difference Between Alive and Healthy
If you look at the average hospital, you'll see many examples of "alive". Everything from a healthy 18-year-old who just needs a few stitches in the emergency room to an 87-year-old with cancer on life support in the ICU. This example illustrates the false dichotomy of simple live/dead viability testing. Meaning these tests that are often used by amniotic and cord tissue vendors (like the 24% viable number given above) only tell you which cells are alive, not alive and healthy. To get that number, you would need to perform much more sophisticated tests (like apoptosis assays), which none of these companies perform. In addition, to get the real number of living and functional cells you would have to have these cells in culture to see how many eventually died versus survived to replicate. Again, something else that's not done by any of these companies. Here's my video on what should be done at a minimum to determine how many cells are alive and functional:
Why 24% Alive Is Just Awful
As a thought experiment, think of cells coming out of freezing as a closed stadium full of people under severe duress. Let's say we suddenly changed the temperature of that stadium by 100 degrees. So everyone is watching a football game in balmy 70 F weather, and suddenly we drop the temperature to -30 F. We do this long enough so that only 24% of the people are left alive by two hours after turning the temperature back up to 70 F. What would the state of that 24% be? Not good. Many would die over the ensuing days. In addition, most would be nonfunctional after having lost limbs or experiencing brain damage or other organ failures. Meaning, knowing that 24% survived tells us something about the harshness of the conditions and the state of those poor people who lived through the horrible ordeal.
Hence, seeing a viability number of 24% tells us that these cells have been through hell and back. Meaning, the likelihood that any will survive for longer than a few days or be completely functional is very, very small. Even if this number were 60%, we will still see very poorly functional cells that will soon die. Again, had 60% in the stadium survived, that still means that large numbers of the remaining people will still succumb or be damaged for life.
This is why experts, such as our lab team and Dr. Fortier, find that despite simple live/dead viability numbers of 20–60%, no cells survive to be functional enough to replicate in culture. Again, think of our stadium experiment.
The upshot? One of the most dangerous places you can be in medicine is not knowing what you don't know. However, this is pretty much the state of an entire birth tissues industry claiming that they are selling vials of young stem cells (that are really all dead). However, now you know better!