This past week I’ve gotten two requests for an amniotic stem cell review. One came from an orthopedic sales rep I know who used the term, “baby juice” in describing what he saw as a clear trend among orthopedic surgeons. The second request for a review came from my assistant, who has had difficulty fighting off a pesky sales rep selling amniotic stem cells in a vial who is trying to convince her that they’re magic.
So first, what are amniotic stem cells and why does my ortho sales rep friend call it baby juice? Babies in the womb are encased in a fluid filled sac known as the amniotic membrane. When a woman in labor has her “water break” this is the sac that breaks open and the amniotic fluid that leaks out is the “water”. The amniotic fluid is what’s now being sold to doctors as a “stem cell product” by sales reps. So does amniotic fluid have stem cells? It does, but it’s very unlikely that any significant number of stem cells survive in baby juice once it’s collected, transported to the processing center from the hospital, processed, frozen, and then shock thawed in doctor’s offices. In fact, if cells did survive, then the FDA would classify this product as a drug and it would be taken off the market pending clinical trials for each indication (right now it’s classified as a tissue without cells and doesn’t need clinical trials validation before being sold). The other product that’s harvested from these tissues is the amniotic membrane (sac) itself. This is cleaned, tested, processed (usually freeze dried) and then either cut into sheets or chopped finely (micronized) for injection. Both of these birth tissues have been used for decades in surgery without any magical properties being applied to them. In particular, the live amniotic membrane has been a mainstay of neurosurgery and in less regulated times the OB ward would serve as a ready supply of amniotic membrane that could be used to patch the covering of the nerve roots, spinal cord, and brain (dura).
So if neither of these modern processed tissues contains live stem cells by the time they’re used by physicians, what do they contain? They do have a bunch of growth factors that can help healing. However, so does the much simpler to obtain and much less expensive platelet rich plasma (PRP). So as far as regenerative potential, there’s likely nothing much better about a $1,200 vial of “baby juice” versus a few hundred dollars worth of PRP, as both contain healing growth factors. Why is the baby juice being pushed so hard right now by overly aggressive sales reps to doctors? It’s a scalable product that fits the traditional pharma business plan (expensive purchased vials sitting in a freezer), while PRP requires a doctor’s office to take blood from a patient and process that blood. Is baby juice a stem cell therapy? Nope. Why are we seeing doctor’s offices advertising amniotic stem cells? Are they using something else? No, they’re using amniotic fluid that by FDA’s own definition contains no live cells. I suspect that reps that should know the difference (like the one bothering my assistant) don’t know what it is they’re selling and the physicians buying it and putting up web-sites know even less.
To provide an example of how clueless many physicians are who are advertising these therapies, this is an example from one I found this morning:
- Lastly, amniotic fluid is a highly concentrated source of stem cells, which makes this type of stem cell injection preferable over embryonic stem cells and the patient’s own stem cells (from fat or bone marrow).
Huh? Where did this physician get this information? Certainly not from the official web-site nor any written documentation of any company selling amniotic membrane or fluid, as none would be allowed by FDA to make this claim. The physician (a surgeon) likely got the information from a rep who showed him a research paper looking at live amniotic fluid analysis, but not the baby juice that the rep was selling. Can you say, “bait and switch”?
The companies and reps selling baby juice should be careful, as FDA has recently cracked down on the manufacturers of amniotic tissue for injection after one company got too aggressive in how it sold it’s product to physicians (I remember that that company also had a pesky sales rep). Why wouldn’t a doctor just buy a simple automated bedside centrifuge and take blood for PRP? Believe it or not, for many physicians the cost of the machine and the fact that you have to draw blood is a deterrent. This is why I call baby juice, “lazy doctor’s PRP”.
The upshot? We’re fending off the next wave in trendy faux stem cell products right now. Last year it was finely chopped (micronized) amniotic tissue for injection (that contained no stem cells). This year it’s baby juice. While these products may have a role as an adjunct to stem cell therapy, they are not a stem cell therapy despite physicians who don’t know better advertising them as such. Through the years, I’ve come to recognize that what sales reps tell me and reality are often two different things. So while we’re testing amniotic tissues in our advanced lab to see if they’re a useful adjunct to stem cells or not, no baby juice shots for us!