The Astonishing Mis-information Being Shared on Amniotic Fluid Products – Part One

Fact Check Amniotic Fluid

Although I recently covered amniotic products in a couple of posts (Another Amniotic-derived Product Mis-states FDA Compliance and Addressing the Flood of Placental Tissue-based HCT/P Products, Again), and thought I could escape the morass that is amniotic fluid containing products, I came across a Powerpoint presentation (PPt) offered up by Dr. Davidson (Park City, Utah) Nanofactor Flow – May 2015 on his website. Rarely have I ever been so unimpressed with a presentation, but what shocked me was the stunningly large number of errors contained in his presentation, which is freely available for any and all to see. Consequently, I will wade into the chaos again in order to correct the plethora of scientific errors in the physician’s presentation.

Since I don’t practice medicine, I will skip over Davidson’s characterization of the medical background on treating orthopedic pathologies with “MSCs” or mesenchymal stem cells. These are terms he uses liberally in the first part of his PPt. Of course, except in one slide, he fails to cite the source of these MSCs. Which is convenient, since later on he speaks glowingly of the MSCs in amniotic fluid. This strategy is nothing more than a bait-and-switch, which he needs to do in view of the absence of any clinical study literature on his highly touted amniotic fluid/tissue-derived product.

The sloppiness begins in earnest on Slide 13 when Davidson claims that stem cells are “better” at differentiation compared to other stem cells. In the first place, he doesn’t cite references for this assertion, and secondly, he doesn’t indicate that the studies are based on in vitro culturing conditions. This might seem like a small point, since, hey, studies are studies, right? Wrong. While you can learn something from in vitro studies, you need to be really careful when extending conclusions from in vitro studies to what is going on in your body. The other point to keep in mind is that the primary mode of action of MSCs is via the “paracrine” effect, which has absolutely nothing to do with differentiation. So much for superiority of amniotic fluid-derived MSCs.

Davidson cites the myth of immune-privileged status of MSCs found in amniotic fluid in Slide 15. Unfortunately for him, this myth has been debunked on a number of occasions. In a direct rebuttal to Davidson’s claim that MSCs from amniotic fluid lack HLA Class 1 or 2 antigens, I cite the recent publication by Dziadosz, et al. (2016), who indicated that if you assessed the cell preps from amniotic fluid properly you indeed could find that MSCs from amniotic fluid expressed HLA antigens, rendering them potentially immunoreactive.

There also is some curious data Davidson cites that indicates that the “NanoFactor Flow” product (AmnioTechnology, LLC) contains 900,000 cells per mL with, incredibly, “44% MSC’s (sic)”. Can this possibly be true? Well, Dziadosz, et al. (2016) indicated that the average yield of nucleated cells from 3-5 mL of amniotic fluid samples was approximately 100,000. Unfortunately, the viability varied from 60-90%. Consequently, if we are to believe Davidson and the company supplying him with his product, it suggests that the amniotic fluid is being centrifuged in order to concentrate the nucleated cells, which isn’t an issue, except that the viability might decrease due to this type of processing. This also implies that the fluid being collected from a single at-term birth is on the order of at least 30 mL or so (that is, to end up with 900,000 cells in 1 mL of product requires at least 15-20 mL of primary amniotic fluid, given the uncertainty in yield and variable viability reported by Dziadosz, et al.).

As for the “44%” MSC claim, mentioned again on Slide 23, you will see that Davidson references a publication from a Chinese journal on cancer (seriously) in support.  I offer up a paper by Loukogeorgakis and De Coppi (2016), who reported that the typical amniotic fluid has about 1% or so stem cells. Let’s be generous and say there are 5% precursor cells, but it still is a long way to having 44% stem cells in the product. Of course, if the company were to culture the MSCs it would be easy to reach a 44% level of stem cells.

I will continue describing in the next post the scientific sins Dr. Davidson presents in the PPt on his favorite amniotic tissue-derived product.

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