Don’t Become an Amniotic “Stem Cell” Victim

by Chris Centeno, MD /

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Is amniotic stem cell therapy, offered by physicians or chiropractors, for real, or is it a scam? To determine what it is and what it isn’t, let’s break it down in an Amniotic Stem Cell Therapy Review.

I’ve discussed the great amniotic “stem cell” deception here many times over the years. The basic idea is that amniotic products don’t have any viable and functional cells in third party testing (i.e. that not sponsored by the manufacturer). Hence, a bait and switch happens when a medical provider gets sold an amniotic product as having living stem cells. The sales rep was either told that lie by the manufacturer or just invents it to sell the product. He or she doesn’t have the educational background to check that claim. The doctor then passes that lie on to his or her patients. These are textbook examples of consumer fraud.

Today, I’m going to discuss what makes these ads consumer fraud and what you can do about if you’ve been a victim. First, let’s review some of the amniotic “stem cell” concerns I’ve shared in the past.

An Amniotic Stem Cell Therapy Review

The biggest fib of all regarding amniotic stem cells (aka “placental stem cells” or “amniotic stem cell factors”) is that they contain live cells. They don’t!  The Interventional Orthopedics Foundation (IOF) tested amniotic stem cells and found that not only did they not have even a single living cell, they also didn’t help older stem cells perform any better, and they didn’t have any more growth factors (and usually less) than simpler and less expensive platelet rich plasma (PRP) injections. Yet, there are many providers out there claiming these dead cells are somehow regenerative and doing exactly what the IOF has found they can’t do. While you might benefit from some of the growth factors found in these products, you aren’t actually receiving “stem cell therapy” if the amniotic stem cells being injected are dead.

Here is important information to help you avoid becoming a victim of cord blood or amniotic stem cell therapy fraud:

What Makes Amniotic “Stem Cell Therapy” Consumer Fraud?

So we know the stem cells in these amniotic products are dead, but in order to benefit from their use, these stem cells need to be alive and healthy. Obviously, it isn’t “stem cell therapy” if the cells are dead. Some providers finagle their way around this by never stating the stem cells are living.

Imagine I advertised a “cute little goldfish pet” for sale. But when you receive the goldfish, it’s dead. Now, in the ad, I never claimed it was living, so my advertising was accurate, right? Wrong! Clearly, a dead goldfish isn’t a pet, so this goes beyond misleading to being consumer fraud. Countless clinics are selling these dead amniotic stem cells via clever wording, but it’s really an epidemic scam sweeping the nation. Selling dead amniotic stem cells is as much consumer fraud as selling dead goldfish.

What Can You Do if You’ve Been a Victim of Amniotic Stem Cell Consumer Fraud?

If you’ve been a victim of amniotic or cord “stem cell” consumer fraud, first file a complaint with the following agencies:

We’d also appreciate it if you’d let us know. One of our missions is to protect consumers from clinics offering substandard care, so we need to know what’s happening out there.

The upshot? Amniotic stem cell therapy as being advertised do not contain viable and functional cells. Whether they’re powdered, in vials on a shelf, sterilized, frozen and thawed, or whatever other crazy processing method is out there today, at this point amniotic stem cells are still just dead tissue, and it’s more likely than not that based on the in-vitro testing, they aren’t going to help any more than a much less expensive PRP injection would. By knowing what to look for and what to expect out there in the wild west of stem cells, hopefully this Amniotic Stem Cell Therapy Review will protect you from becoming a victim of consumer fraud.

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18 thoughts on “Don’t Become an Amniotic “Stem Cell” Victim

  1. Kishore Jayaswal

    Can’t ambiotic stem cells be grown, harvested, and maintained?

    1. Chris Centeno Post author

      They can if isolated fresh, but that would be illegal in the U.S.

  2. Anthony Cook

    Is Dr Centeno saying NO amniotic stem cell injections contain live, viable, functioning stem cells?
    Or is he referring to just some batches of amniotic fluid being used for amniotic stem cell injection therapy?
    I just watched a video here, https://www.thehealingmiracle.com/epi_6/[email protected]&view_key=348a4dt4a61702e3a131e0f9459c740wacd48&inf_contact_key=fb83fd71675d7d6736825abe7026b41283ff2a9bde2cf5b291f74a022a27fbb3 , where patients underwent such procedures, and the stem cells arrived from the manufacturer packed in dry ice.
    Elsewhere in the video series I’ve seen several emphatic testimonials by patients that seem to confirm their miraculous recoveries from amniotic stem cell injections.
    What’s going on?

    1. Chris Centeno Post author

      Near as we can tell, after testing many preps, none of these preparations contain live and functional stem cells. The Healing Miracle is a paid ad campaign for a chiropractic group that is promoting amniotic therapies. You should note that many of the patient advocates for stem cells in the video didn’t get amniotic therapy at all, but received their own stem cells. See https://regenexx.com/blog/jeff-hayes-healing-miracle-truth-stem-cells/

  3. Bob Funke

    I received two amniotic injections. The first one was in my left knee in April 2016 after x-rays showed my knee was bone on bone. I acheived great results. I returned to biking 30 miles at a stretch in the summer with no problems. I had occasional pain from sitting in cramped quarters at times, but that eventually went away.

    However, I started noticing unrelated pain in my right hip after my knee got better. As it got more difficult to walk, I had it looked at by an orthopedics specialist. He said I had no joint left and said I can get cortisone injections or a hip replacement. Instead, I got another amniotic injection beginning of December 2017. It’s eight weeks and results are very encouraging. There is no more grinding in the hip. As I go through the physical therapy follow up, my mobility is improving a lot. I expect within 2 – 3 weeks, I will be able be fully active.

    The doctor who gave me the injection said he was once skeptical, but he tried it to treat his shoulder. Now he says he feels he could pitch for the Cubs. He made no claims to the stem cells being alive, but indicated that the amniotic fluid stimulates activity with the stem cells that are already present.

    The results are great Regenex should consider offering it rather than dismissing it.

    1. Chris Centeno Post author

      Bob, great to hear that your doctor didn’t try a bait and switch and claim that there were live cells! These are growth factor shots and as such, can help the pain. However, they likely work about as well as a PRP shot that costs about 1/3 to 1/4 as much. However, if they worked for you, that’s great! We do offer these injections at Regenexx, we just don’t call them stem cell procedures and we realize that they are an expensive alternative to a much cheaper PRP injection.

  4. Steven Guggi

    Dear dr.,
    My mom had amniotic stem cells to knee on June 29, 2017. Right after treatment she felt ill. We thought something was wrong. Doctor took fluid from knee no infection just inflamation also ordered blood test. WBC slightly elevated red blood count low, esr high, crp high. Always had normal blood work before last normal test April, 2017. The stem cells are from burst biological. Tested for a lot of infectious diseases nothing has come up but I am sure it still could be because they do very little testing of donors. I have the package insert that lists what they test for. Numerous other test for vasculitis etc. all neg.
    Esr now is 109 and crp is 112 also animea from inflammation we think. we keep testing as
    it changes. We were led to be leave they were live stem cells. I only found out they are dead. Thank you for your web site as I do think this is fraud. If you know of any toxins added to anmionic stem cellls or adverse reaction please advise. Also I think rejection is not an issue but could they set off an immune response.
    Thanking you in advance,
    Steven Gugggi. 845-783-4812

    1. Chris Centeno Post author

      Please report this to the FDAs Medwatch system, see https://www.fda.gov/Safety/MedWatch/default.htm . Physicians and scientists who have noted reactions like this from amnio/cord products (patients who end up in the ER or ICU) have postulated that these may be graft versus host disease reactions. We have been told that these products are immune privileged (i.e. don’t cause a rejection reaction in the patient), but to the extent that there may be any small amount of live cells that die off over hours after injection, this may be enough for the body to go into overdrive to try to get rid of the foreign cells.

  5. Joan Allen

    A friend received an injection for a damaged pudendal nerve
    Anu RHEO™
    Amniotic Fluid Matrix Products

    Is this the same as stem cell therapy and possibly a hoax? Very expensive with no results

    Anu RHEO™
    Amniotic Fluid Matrix Products

    1. Regenexx Team Post author

      Joan,
      None of the amniotic products we’ve tested contain live stem cells. This product is listed on the company’s website as FDA 1271, 361. If it contained live stem cells because this product does not come from the patient, is not used in the way that it is used in the body, and is more than minimally manipulated, it would need to be classified as a FDA 351 Drug, and would require the same drug approval process as prescription drugs. Please see: https://regenexx.com/blog/using-common-orthobiologics-explain-fda-1271-regulations/

      1. Joan Allen

        Too medical for me to understand. So would an amniotic fluid injection regenerate a damaged nerve and if not do you know what would? Any suggestions for pudendal neuralgia?

        1. Regenexx Team Post author

          Joan,
          Platelet lysate has great potential in the treatment of nerves in the hands of a physician with this very specific, highly specialized, skill-set. Please see: https://regenexx.com/blog/nerve-regeneration/ and https://regenexx.com/blog/athletic-pubalgia-surgery/. If you’d like to see if your particular case would be a Candidate, please submit the Candidate form to the right of the blog.

  6. George Walker

    So what is the name for “live” stem cell treatment?

    I’ve read a few places now that you need live cells. Does your company provide live cell treatment outside of the US?

    1. Regenexx Team Post author

      George,
      Yes. We use only live stem cells from the patient’s bone marrow, throughout the US and internationally. Here is where you can get Regenexx procedures: https://regenexx.com/find-a-physician/ This explains the difference: https://regenexx.com/blog/orthopedic-stem-cell-treatment/

  7. Andrew

    Hi,
    I know you can only answer so much online with pieces of one’s story, but I am interested in your input given your credentials and experience.

    I’ve come to find out I have a “midly” herniated disc in L5-S1 on the left side from an MRI. I had 2 left SI cortisone injections before the MRI which felt great for 2 months (before we know it was L5-S1) and recently L5-S1 cortisone injection that lasted a few weeks.

    My doctor is recommending A2M – alpha-2-Macroglobulin injection to address it. I hate to be the guy who’s not a doctor reading internet research instead of trusting my doc but for $2300 out of pocket, I’d like a little more confidence in my investment. I asked about PRP as I’ve read PRP is what actually rebuilds. The response was that in the Epidural area where my concern is, PRP would not be appropriate, A2M is the appropiate treatment for the area and they’ve offered to include an amniotic fluid injection for “Free” normally $1400.

    ….In my business, I can’t afford to give a few hundred bucks away without affecting my profit significantly. There’s no way I could give away $1400 of ACTUAL VALUE for free. I don’t buy it.

    $2300 is a hell of a lot less expensive than surgery and if it at minimum even prevents further degredation, it is worth it at 30 years old. And if it rebuilds or makes the pain go away, even better. I’d just like a little more than “we don’t know, we’ve just got to try it and see” for $2300.
    What are your thoughts?
    Andrew
    702-290-2938
    Thank you for your time.

    1. Chris Centeno Post author

      I blogged on this today as the answer is more complex than a single reply.

  8. Mary

    Note sure when this article was published, sounds like a year to 9 months ago, see link to full article below.

    “Last week, the Utah Cord Bank announced that they have the first ever birth tissue product to have colonizing forming units (CFU’s) in their products. This finding is monumental and couldn’t have arrived at a better time with all of the FDA crack-downs. The CFU assay is one of the most important assays for measuring the vitality of your cryopreserved cell sample.”

    https://stemcellhealthcenters.com/utah-cord-bank-third-party-colony-forming-unit-assay/

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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