POSTED ON 04/03/2019 IN Uncategorized BY Chris Centeno
Weve been testing amniotic and umbilical cord products since 2015. In that time we have tested all types currently on the market, and despite thewild claims of birth tissue vendors and physicians that these products contain many live and functional mesenchymal stem cells, they have all had none. Today we add a Whartons jelly product to that long list. Let me explain.
MSC stands for mesenchymal stem cell. This is an all-around cell that has been tested in many animal models and now several clinical trials and found to be likely helpfulin orthopedic care. This is why we see some umbilical cord product manufacturers claim to have MSCs in their products, as it justifies the pricing at about 4050X the price of gold.
Do you remember this guy from Saturday Night Live in the 80s?
He would tell the audience something that was clearly false and then follow up with his line, Yeah, thats the ticket
When this massive birth tissues scam began in approximately 2013, I first realized something was off when I found a booth at a conference hawking amniotic tissue as a stem cell product. This couldnt be true as theproduct was dehydrated and gamma irritated to kill all living tissue, including viruses and cells. From there the myth grew to include a new type of product, one that was made from frozen amniotic fluid. We tested several of those products and found no live cells, let alone stem cells. Then the mantra changed to the concept that amniotic fluid was a growth factor product. The problem? Our testing (and that later performed by Lisa Fortier at Cornell) showed poor growth factor levels compared to platelet-richplasma. Then the myth changed to the idea that it was umbilical cord products that clearly had live and functional MSCs. We then tested our first cord blood product in 2017 and found no MSCs. Then we began collecting samples like box tops for one larger study. In that time, others, like Lisa Fortier, DVM, PhD, from Cornell published confirming our results. Then the story changed to, of course, cord blood doesnt have many MSCsall of those are in the Whartons jelly part of the umbilical cord! Hence, this is our first test of an umbilical cord WJ product.
A while back, Utah Cord Bank claimed that it had an umbilical cord stem cell product that produced CFUs. What is that? A CFU is a colony of adherent cells, and one type of that assay has become a standard way to measure the MSC content of tissues like bone marrow. To learn more about that, see my video below:
The good news is that multiple studies have linked CFU content to the potency of stem cell-basedtherapies in orthopedics. The higher the number of CFUs present in of the substance being used, the better the therapeutic results. Utah Cord Bank published this image (bottom), which I compared to an actual CFU (top):
Basically, the companywas calling a tiny spec of cells that you could barely see (the top plate with about 30 cells) a CFU, while on the bottom, real CFUs from bone marrow actually had thousands of cells each. So I knew testing a Utah Cord product would be really interesting because this is the only company that has purported to show any type of CFU result.
We tested StemVive the same way we have tested other products, using a live/dead stain and a CFU-f assay. The initial viability when the product was thawed per manufacturers instructions was in the 40s. Thats fairly typical for these products. We then plated it side by side with a random patients bone marrow sample at 10,000 and 30,000 cells/cm2. We then incubated it and observed the cultures for two weeks. By 24 hours, despite the ideal culture conditions (10% FBC+AMEM+bFGF), everything was dead. This is also typical for what we have seen with birth tissue products. Anything that initially looked alive on live/dead stains dies off quickly. How can this be? Given that more than 40% of the cells were initially alive? Watch my video for an explanation:
What we noted was that while there were a few candidate fibroblastic cells in StemVive that could have been MSCs, by the first week, these had also died out. The two-week stains are at the top of this blog. In the old guy bone marrow samples, they show purple dots, which indicate CFU hits on the CFU-f assay. These are the first part of the ISCT guidelines for identifying MSCs in a sample (adherence to plastic). So the bone marrow was positive for MSCs (which would then need to be confirmed via flow cytometry and other lab testing) and the StemVive (all white with no purple dots) was negative.
In conclusion, the StemVive product we tested had poor viability (good would be in the 90s). It was all dead by 24 hours, which means that much of the sample that was initially testing as alive was actually alive and dying. Finally, no MSCs were in the sample to attach to plastic.
We have tested several umbilical cord products and found them to all have no viable and functional MSCs, and Lisa Fortiers lab at Cornell has also tested several. However, I cant rule out that every sample out there will test this way. However, theres only a limited suite of things that manufacturers can do to these products and stay FDA compliant on the processing. Hence, its very unlikely that other products and samples will produce different results.
The upshot? Can we please end the sales calls by orthopedic sales reps who dont know what they dont know hawking vials of stem cells? Despite test after test showing that these reps and companies claiming live MSCs are committing fraud, they still continue. So please stop
*DISCLAIMER: Like all medical procedures, Regenexx Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.
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Umbilical Cord Stem Cell Review: StemVive from Utah Cord ...
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