Lowering the Stem Cell Bar: More Amniotic Stem Cells

by Chris Centeno, MD /

amniotic stem cells

My son loves the cartoon TV series South Park, and one of my favorite episodes is where James Cameron is enlisted to find out just how far the societal bar has been lowered and how to “raise the bar.” Just when I thought the stem cell Wild West couldn’t lower the bar any farther, here comes a new business plan—practice-management companies hawking amniotic stem cells as income generators for chiropractic clinics. This is truly a new twist, one that’s as disturbing as it is bizarre. So how far has the bar been lowered?

Lowering the Stem Cell Bar to Date

We’ve seen many things that have lowered the stem cell bar so far:

  • Doctors taking a weekend stem cell course and declaring themselves experts in the field
  • Websites listing research studies that have nothing to do with the type of stem cell care being offered
  • Doctors offering to treat 20–40 different incurable diseases with stem cells

However, the new trend lowers the bar still farther with amniotic stem cells.

Amniotic Stem Cells For Sale

I’ve blogged extensively about these amniotic products before, but to review, while these likely contain helpful growth factors and some “extracellular matrix,” they are not stem cell products. However, when orthopedic sales reps tried to sell this stuff as what it is, it didn’t sell well. So the reps, based largely on the fact that the amniotic fluid and membrane have a low content of stem cells when fresh out of the obstetrics ward, began to tell physicians that the stuff was loaded with stem cells. After that, 1 cc vials of “baby juice” (amniotic fluid that surrounds the baby) sold like hotcakes for more than $1,000 each.

Let’s do some math to better understand the genesis of the amniotic business. Given that the price this morning for gold is about $1,200 per ounce (28 grams) and a ml of fluid weighs about 1 gram, this “baby juice” costs about 25 times the price of gold! Also, considering that the average baby has 400–1,200 ml of amniotic fluid at term, if we use the 800 ml number, that makes each delivery worth about $800,000 retail! That doesn’t include the amniotic membrane or chorion (which make up the sac that holds the fluid). Add in an easy $200,000-$400,000 more for those tissues and we easily have a million-dollar delivery.

How can the disposable tissue after birth be worth a cool million? Well, when it’s fresh, there are some amniotic stem cells available in these tissues, but once these are processed and frozen, there aren’t much. In fact, the IOF tested these products and found that none had any living cells by the time they were thawed as a product and certainly none had living stem cells. This is despite physicians telling unsuspecting patients that each 1–2 ml vial has 2 million amniotic stem cells.

Up until I did the math on how much each birth generates in revenue, I never fully understood why the four or five major tissue banks in the U.S. were signing up new companies every week to private label their amniotic products. You see, even you can get into the amniotic stem cells business tomorrow just by approaching a tissue bank. You would ask that they file an FDA 361 registration on your magic baby juice and then recruit orthopedic sales reps. Within a few months, you would be in business for about a thousand bucks a vial.

The Chiropractors Trying to Keep the Bar High

First, I have great respect for chiropractors and refer to them all the time. However, the guys and gals I work with would never get involved in lowering the stem cell bar. They know what they’re good at and focus in that world, which makes them very effective at helping patients.

The new group selling decellularized baby juice to chiropractic clinics actually came to my attention through a chiropractor who owns some of our clinics. He’s a good place to start to set apart what he and others like him have accomplished from this most recent income-generating soiree.

The chiropractors I know who are involved in regenerative medicine and who are doing this right have spent a huge amount of time and resources on expertise. They have looked far and wide to find expert physicians to hire, at considerable cost. They have joined a group of physicians measuring clinical outcomes or are measuring their own. They have ensured that advanced imaging guidance is being used for injections. They offer patients a realistic appraisal of what to expect, and they steer clear of being dishonest about the technology they’re offering. So before I delve into the baby juice factory, let me applaud the guys that work hard to do this right.

Lowering the Bar

This week, two events happened that made me aware of this most recent nutty trend lowering the stem cell bar. First, the Interventional Orthopedics Foundation got an e-mail from a chiropractor in Georgia who runs an amniotic stem cell clinic. He was upset that the IOF’s research didn’t show that amniotic fluid products contained stem cells. Second, a chiropractor who is doing this right sent this e-mail on the same day:

“…we are seeing an epidemic of new groups emerging that make claims that have little justification. Below is a link to a group that has emerged out of a consulting company that has been promoting MD/DC practices for several years and have now added stem cells. In fact, they only provide amniotic injections without saying stem cells, but their name implies they are doing stem cell therapies. The consulting company advises chiro’s to enlist a MD to become a part time medical director and hire mid-levels to do the actual care. Or, they have a physician come in one or two days a week.”

When I hunted down the chiropractor in Georgia who was upset about the IOF’s research and the company that was signing up chiropractors to bring in physician assistants to get baby juice injections, their websites looked curiously similar. The explanation above seemed to fit. The Georgia chiropractor’s website was rife with references to amniotic stem cells therapy, despite the fact that our data and the FDA registrations for these products show that they contain no stem cells. The e-mail above also shows how this new Wild West business plan works.

One of the scenes from that favorite South Park episode is above. James Cameron goes deep into the ocean to find just how low the bar has sunk and tries to “raise the bar.” So let’s see just how low the amniotic stem cells bar has sunk.

The types of physicians with high levels of training to perform a bone marrow aspiration and/or liposuction and with the image-guided skills to place stem cells into very specific areas of the body are expensive and hard to find. So the new chiropractic baby juice business plan seems to say, “Why go through the brain damage of ensuring the doctor knows what he’s doing? Just hire a physician’s assistant or nurse practitioner.” They generally have no idea how to perform a stem cell harvest procedure and can generally only perform the simplest joint injections. However, they’re about one-third the price of a skilled physician. In addition, just hand them a vial of dead cells and claim that it’s a vial of amniotic stem cells; who will know the difference? When a lab with access to millions of dollars of equipment has a PhD-led stem cell team dig deep into whether there are stem cells in amniotic fluid products and finds none—complain! After all, why spend your own money on doing the testing before injecting this stuff into patients? That just takes profit from the bottom line.

Raising the Stem Cell Bar

If, like James Cameron, we’re going to raise the bar in stem cell therapy, what would that look like? How would that differ from the new chiropractic business model?

  1. If you say you’re injecting stem cells, there actually needs to be viable stem cells that are freely available to act on the body. This would seem to be a no-brainer, right? However, to many physicians hawking vials of dead baby tissue as viable stem cells, it seems a hard concept to grasp. Why let reality get in the way of a great business plan?
  2. The “doctor” injecting the stem cells actually has to have advanced knowledge in how to take and place cells. In this case, you can’t substitute a physician extender or a family doctor who barely knows how to inject a knee.
  3. Spend the bucks and resources to be able to perform your own research or have others do the same on your behalf. A problem here is that the chiropractor group was gullible enough to believe the sales reps who said that there were viable amniotic stem cells in these vials. When they heard there likely wasn’t, they needed to have their specific brand tested and dig deeper.

There are many other standards that we should be enforcing, but these three simple ones would go a long way toward raising the bar.

The upshot? The stem cell bar gets lowered daily. Being the first physician in the U.S. to have done this work and spending a huge amount of money every year publishing research and investigating in the lab what’s best for patients, it’s upsetting to see how low the bar has sunk. We spend our own money testing the claims of sales reps, like the claim that this little magic vial has millions of amniotic stem cells. I guess the best I can do is to educate physicians and patients about where the bar should be!

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13 thoughts on “Lowering the Stem Cell Bar: More Amniotic Stem Cells

  1. John

    Dr. Centeno,

    Thank you for posting on this topic. I work for a facility that purchased Placental Derived Amnion. They do not state that there are stem cells in the product. They only advertise growth factors, proteins, etc. I adamantly profess that there are no stem cells present. I am concerned that these companies are selling a product to chiros. that legitimately want to hep their patients. By the way I am an NP, mid level and physician extenders are misnomers. Just call us NP’s please. Regardless, again I thank you for writing about this topic. It greatly concerns me.

  2. Chris Centeno Post author

    John, thanks for writing. Yes, there are a few companies that sell this stuff that are trying hard to do it right and we applaud those honest players. They don’t claim there are stem cells. Having said that, most physicians advertising this stuff on their web-sites do claim it has stem cells. I certainly know of several legit docs who are using amniotic tissues as ECM or a graft extender for things like rotator cuff and ligaments injections, which may work well. In addition, it may also help knee arthritis symptoms, but so can a $200 PRP shot, so the question is whether this stuff is any better than less expensive products like PRP.

  3. Richard Striano

    Chris thank you first for recognizing those in a collaborative environment that are both doing it right and exerting years of study along with attendance at conferences and training programs to stay on the cutting edge and provide valuable outcome contributions to the field by using advanced ultrasound techniques and applications for ortho-biologics treating musculoskeletal conditions. Second by pointing out that chasing money before having talent always leads to poor outcomes for all of us. That being said I am acquainted with many brilliant DC’s, MD’s, DO’s, NP’s and PA’s (i dislike the term “Chiro”).

  4. Maria E Walker

    Great article, in my search to find what to do with my own pain problem, I have been researching the stem cell approach. About 4 years ago I had PRP done to my knees, it worked for awhile in my left knee but the right knee would get very swollen and did not take the therapy.

    Now I am in search of treating my lower back, hips and knees pain through using stem cell therapy and I am looking for a reputable place to do it.

    What kind of therapy do you use for all of these joints? and do you mind naming price?

    1. Regenexx Team

      Maria,
      We use either our patented Regenexx-SD stem cell procedure, or one of our many platelet procedures. What is the best procedure for each situation is determined by exam and customized for the patient: https://regenexx.com/blog/advanced-customized-orthobiologics/ Lower back, hips and knees is a common constellation of issues and are often related. http://www.regenexx.com/the-regenexx-procedures/knee-surgery-alternative/ http://www.regenexx.com/the-regenexx-procedures/back-surgery-alternative/ http://www.regenexx.com/the-regenexx-procedures/back-surgery-alternative/ A price quote is not possible as the procedures needed would determine that. If you’d like to find out if you’re a good candidate for a Regenexx Procedure and chat with one of our doctors about your case, please fill out the Candidate form.

  5. jim

    Hello Dr. Centeno,

    Another great blog post. I’ve been following your informative posts since late November, 2015. I can tell you this fact for sure. On December 16, I learned my knee is at a stage 4 condition and in need of a TKR, and by getting informed from all these discussions in the last four months, I feel very confident what to do when I can’t take the pain any longer.

    Your writing and this blog site is connecting with at least one person out in the wilderness who would otherwise be totally in the dark and could very easily have been led down the garden path, to a long term miserable sub-optimal decision.

    Keep it up and thanks,

    Jim…..from Southern France

  6. Chris Centeno Post author

    Thanks Jim, the amniotic industry is not happy about these posts. However, we were legitimately excited a few years back as the prospect of young, off the shelf stem cells that existed in a regulatory loophole is what made us spend our own money to test them. However, once finding nothing viable, we were pretty bummed and wanted to make sure everyone else didn’t fall into the same trap.

  7. Valerie Davis

    okay, my name is Valerie Davis and I had an appointment to have the Bone Marrow stem cells injected in both knees but Insurance will not pay for it so I had to wait 6 month to save for the procedure, that was in Aug 2016, in March my husband (who has had 1 knee replacement and 1 hip replacement) told me his other knee was really bad. So I was going to postpone my treatment and let him do his knee, my was just a torn Meniscus and I had It scoped but it never got better, instead it got worse. but his was almost bone on bone, so this other Dr Wersland talk to us about Amniotic treatment, I have been reading your articles about the difference and told Dr Wersland about what you said about the Stem Cell not being Alive when they are injected and he said that it was not true and that he seen them, I said you looked in a microscope and saw them, he said yes. so then he offer to do my knees, my neck and my husband knee and shoulder for a discount 18 month free interest loan and the injection of amniotic fluid and PRP, 8 weeks of physical therapy, and adjustments for $17,000. so I just had my knees done yesterday, they feel good, the jury is still out. but now I get this new letter and I kinda feel like I have been ripped off or taken for a fool. did I do the right thing, who is lying, who is telling the truth? I am just a lay person and don’t know what to think. what can I do now?

    1. Regenexx Team

      Valerie,
      The Amniotic “Stem Cell” Issue is a problem we’re in the midst of addressing. It’s a problem because the manufacturers of the products being injected do not claim that there any live stem cells in the product (because they can’t), yet distributors of the product are selling it to doctors, chiropractors and even acupuncturists as containing live stem cells. Sadly, I honestly doubt that this Dr. was able to “see live stem cells” in the product as it would take the type of equipment we have in our University style equipped lab, and with that very sophisticated equipment, we have looked and there are no live cells of any kind . These products do contain some helpful growth factors, so it would have similar potential to generic PRP, which may provide some relief. However, PRP shots for you and your husband should only run a few thousand dollars at most.
      We spend a lot of time and resources doing our best to get educational information to the public, however sadly, the lure of profit is too great for some to resist. In the meantime we will hope with you that the helpful growth factors contained in the amniotic injection you paid for will been enough to see improvement!

  8. Valerie Davis

    So, another thing they told me is that at my age (63) my bone marrow stem cells are not that good, is that true. do you recommend older ladies like me to have bone marrow over amniotic even if there are not as many stem cells in our bones, I am very healthy. but at least they are alive. will it still be enough?

    1. Regenexx Team

      Valerie,
      Regenexx procedures are always customized to match the age and health of the patient as well as the tissue and area that we’re targeting. So age is not a factor in Regenexx knee stem cell treatment: https://regenexx.com/blog/advanced-customized-orthobiologics/ We would recommend bone marrow over amniotic for stem cell treatments at any age, because stem cell treatments require stem cells, and amniotic, and/or placental products contain no live stem cells. There should be no problem with harvesting enough stells!

  9. Chris Centeno Post author

    Valerie, we have seen no evidence that age impacts the outcome of a Regenexx knee stem cell procedure.

  10. Valerie Davis

    so, what about these people who save the placenta in a freezer safety box or something like that, for 10 years for their child incase, they or their child needs it. how is that different than the stem cell injection in the joints, from the placenta or amniotic membrane or chorion, (which is what my injection were) how is it different. are they alive still after being froze for 10 yrs.? do they have to treat them before using them. and Susanne Summers used fatty stem cells for her breast implants and is doing well, I know several people who have that done. is doing my meniscus better if I get it from my bones because it is from bone marrow? and fatty adipose I oaky for other things. so many questions.

Chris Centeno, MD

Regenexx Founder

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.
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