More Research Published That Amniotic Products are Dead Tissue

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One of the biggest scams in the wild west of stem cell therapy right now is providers and sales reps claiming that amniotic fluid products have many young and viable stem cells. We first tested this theory back in 2015 and were lambasted by birth tissue vendors for reporting that we found no stem cells. Now, two other labs have weighed in at Cornell and UC Irvine that also found no cells. I’ll review that third study this morning.

The Scam

Before I get into who has published what, it’s critical to understand what prompted all of these research investigations. Back in 2014/15, we began to see sales reps hawking amniotic fluid products. This is the fluid that surrounds the baby in a live birth. The problem began when the sales reps claimed to doctors that this product had live stem cells. While that justified the product’s high price, this information was passed to physicians who told patients, who believed that their amniotic fluid injections were really stem cell procedures. We documented one of these scams in a video below:

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Our First-of-Its-Kind Research Study on Amnio Products

Back in 2015, after being approached by several sales reps claiming to be selling amniotic fluid with stem cells, we told a sales rep that we would agree to test several samples for stem cells. This is possible because we have a university-level lab at our HQ site in Colorado. We first tested a product called BioD which was supposed to have millions of live mesenchymal stem cells. When we found no stem cells and saw that the number of products being offered was exploding, we partnered with the Interventional Orthopedics Foundation (IOF) to test many different products. We found no live stem cells in any of these amniotic products. We presented that data at the 2015 IOF conference and moved on. 

Getting Attacked and the Second Study

Regenexx has been the first in many things, so we’re pretty used to getting attacked for being way out front. However, the ferocity of some of the attacks by the sales reps for the companies selling amniotic products was interesting, to say the least. We were accused of running the wrong tests, having an incompetent lab staff, being biased, having an ax to grind against competitors, you name it. Hence, it was with great relief we reported that in 2018, renowned orthobiologics expert Lisa Fortier at Cornell said this on a medical journal podcast:

Turns out her lab presented its data showing that both amniotic and cord blood products didn’t contain live stem cells at a national conference as well. 

A Consensus Statement

I organized a consensus statement with many orthobiologics thought leaders early this year. There was widespread agreement that these amniotic and birth tissue products didn’t contain live stem cells and that providers who were claiming they did were defrauding patients. This was a great step forward to have legitimate providers of orthobiologics begin to push back against the scams.

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The Third Study to Find No Stem Cells

This week, a brand new study was published in conjunction with UC Irvine that looked at three amniotic fluid products (some of the same ones we tested in 2015). Interestingly, the researchers invited seven companies and only three agreed to provide the product. That’s also been our experience. Since our 2015 research, many of these companies won’t send us any product to test.

This new study also found no stem cells in any of these products but did, of course, find stem cells in bone marrow. Of note, the researchers also found no mesenchymal stem cells in fresh amniotic fluid. Finally, the other cells found in the commercial products were also dead.

The upshot? Can we finally stick a fork in this whole amniotic fluid stem cell scam? Now that we have three labs all reporting the same results, it’s time for local and national law enforcement and regulators to go after any clinic or sales rep claiming that these products contain live and functional stem cells. Enough already…

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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