I’ve blogged quite a bit on amniotic stem cell injections this past few months because this is such a hot topic. There are clinics popping up all over the place claiming to be performing amniotic stem cell therapy. In the past few years, a new product entered the market, amniotic fluid, with the physicians using it claiming that they are injecting highly concentrated stem cells. We just tested some of this stuff and not surprisingly, we didn’t find a single living stem cell!
Here’s an example of the physician marketing:
After researching the various products and technologies available on the marketplace (their safety, efficacy, etc.), providers at XXX Institute have chosen BioDFactor® Viable Tissue Matrix as an excellent amniotic stem cell therapy platform. The safety and quality of this product is unrivaled… Additionally, all BioD subsidiaries are registered as tissue banks with the FDA and accredited by the American Association of Tissue Banks.
Near as we can tell, BioDFactor is basically amniotic fluid or some liquid part of the placenta. The tissue registration listed on-line has it under the category of “Cord Blood”, but then states-“BioD Factor-Placental Stem Cells”. The package insert doesn’t really say what it is, other than, “BioDfactor™ is a biological wound covering derived from the human placental organ and comes frozen in a vial.”
Amniotic fluid is what surrounds the baby. When the mother’s water breaks, this is the fluid that ends up on the floor. The placenta is the part of the baby’s sac that attaches it to the mother’s uterine wall. Amniotic and placental tissues from the birth sac have been used for a century or more as a filler for the damaged covering of the spinal cord and in eye procedures. Way back when, a surgeon would make a visit to the OB ward and pick up some of this stuff to sew into a defect. In the 1970s when FDA tissue regulations went into place, companies could make a little money selling it to hospitals and surgeons. About 5 years ago, some smart businessman got the bright idea to begin marketing placental tissues as an injectable regenerative medicine product. They took the birth sac and freeze dried it, chopped it up into very fine pieces, and put the powder in a bottle. I recall one of these companies who had incredibly aggressive sales reps and tactics. The companies then went to medical conferences to convince doctors to inject it for problems like tennis elbow. Now there wasn’t a shred of evidence that this stuff would help tendinitis or any other orthopedic condition, but that didn’t matter, it was a “regenerative tissue”. The sales were pretty good, but at some point some smart sales rep got the idea that if he told doctors that this was a “stem cell” product, that would sell more vials of the stuff. Sure enough, sales went through the roof! Never mind that freeze drying or processing the living membrane made sure it had no living cells of any type let alone stem cells. Most doctors, who were new to the concept of stem cells anyway, bought this marketing “little white lie”-hook, line, and sinker. Then came amniotic/placental fluid, which was marketed the same way. This was perhaps more believable as a stem cell product, because it was a frozen fluid and you can find research that when surrounding the baby, this fluid does contain some stem cells. After I was told by a knowledgeable sales rep about the rich stem cell content of amniotic fluid, we decided to test these claims.
As many of you know, we check all manufacturer’s and rep’s claims before we recommend anything to our network providers. We also do this at our expense so there are no potential conflicts (i.e. a manufacturer that funds a study). We also have a research lab outfitted like any university research lab in the country, so we have the ability to run these tests and separate fact from fiction.
First, if you go to the web-site of any company selling amniotic powder or fluid, you won’t see a word about stem cells (although as I have shown above at one point an older tissue registration form discusses “placental stem cells”). Why? These web-site claims are heavily regulated and a single claim that there are stem cells in this stuff would result in the tissue being classified as a drug product and taken off the market to undergo a decade of testing costing hundreds of millions of dollars. However, what the sales reps tell physicians behind closed doors is another thing. In that world, reps meet physicians who would love to “get into stem cells”, but don’t want the hassle of buying equipment, learning and mastering a harvest procedure, and dedicating the staff to run the machine that isolates the stem cells. They want something that will sit on the shelf that contains stem cells that they can use when the need arises.
What are sales reps claiming to doctors behind closed doors? As an example, on Friday I spoke to a physician from the Northeast who was told by a sales rep that the amniotic fluid he was selling had 25 million stem cells per 1 ml vial! Impressive if it were true. We’ve had our doubts given what we know about cell biology learned from a decade’s experience of culturing and researching stem cells, but we were happy to test it. Why? If through some miracle of the preservation technique and biologic heartiness of amniotic stem cells there were a significant number of mesenchymal stem cells in a vial, this could potentially be used to help patients.
Several months ago we bought several vials of BioDFactor and stored it under the manufacturer’s recommended parameters. We then thawed it using those directions and plated the fluid using standard growth media and incubation techniques that support stem cell growth. The results? WE GOT NO VIABLE CELLS. ZILCH, NADA, ZIPPO…
Why? Doesn’t amniotic fluid contain stem cells? Aren’t there really 25 million cells per ml? Not so much. This is a quote from a paper on the topic:
Kaviani and coworkers reported that just 2 mL of amniotic fluid contains up to 20,000 cells, 80% of which are viable.
So while there may have been 10,000 stem cells per cc (a very small amount) when the fluid was surrounding a baby, once that stuff is handled by hospital staff, stored, and then shipped to processing center, shock frozen without cell preservation media, and shock thawed at a doctors office-no living material remains. In fact, if there was anything living in the vials being sold, good cell therapy handling practice would dictate that the cells would have to be controlled rate thawed and recovered using a sophisticated lab over several days to ensure that some tiny fraction survived.
The upshot? While this stuff may have growth factors like PRP and who knows, may have other trophic effects on other cells, claiming it’s a “stem cell procedure” is neither accurate, nor honest, based on our data. In addition, the manufacturer’s web-site also makes no such claims. However, since the reps tell the doctors that there are stem cells in this stuff and the docs regurgitate what they’ve been told to patients, there’s a whole lotta monkey business going on. In the end, based on the information we’ve collected, claiming amniotic fluid or membrane procedures are stem cell procedures is about as accurate as calling a holy water injection a stem cell procedure!