You would likely think that I really enjoy writing about the stem cell wild west or the explosion in scams related to regenerative medicine. I really don’t, as there’s usually something better I need to do. Hence, I only write when I see something really exploitative. I would put “Stem Cell Therapy for Pain” in that category. The head of this outfit seems to be somehow related now or in the past with “Stem Cell Institute of America,” but her clinics are now called “Stem Cell Health Centers.”
I had actually started this blog post a while back, but other projects got in the way. However, I went to get my hair cut this weekend for upcoming lectures and there was Jill Howe on TV in a paid ad concocted to look like a network news program. As I watched her misinform consumers while getting my unruly hair tamed, I thought to myself, I know what tomorrow’s blog will be.
The Chiro “Stem Cell” Explosion Is Metastasizing Daily
A while back, I participated in a video that showed what was going on with the explosion of chiropractic-led “stem cell” therapy seminars. See that video below:
Basically, these chiropractic clinics often follow the same game plan. Hire a nurse to perform simple injections of birth tissues, like amniotic fluid or umbilical cord tissue, that are regulated as, and known to be, dead cell products. To get people in the door, you aggressively market “stem cell” therapy seminars on local TV and in newspaper ads targeted at the elderly. Pack a room with loads of people by offering free dinner and then promise the attendees that they will receive young stem cells (even though the products you’ll inject are dead) and then show them miracle-cure X-rays that purport to show that large stretches of new cartilage have been grown in bone-on-bone arthritic knees. Offer aggressive discounts to get the elderly patients to sign up, and then use a nonmedical person or nurse to determine candidacy. Pretty much everyone is a candidate, so that step is a mere formality. Some of these patients will get some relief for a while because they got what amounted to a hyperexpensive platelet-rich plasma shot, but none of them actually got an injection of young stem cells.
Jill Howe’s Magic Amniotic Stem Cell Pitch
I first saw Jill Howe, a chiropractor, on a pay-for-play news program a few years back. She had a pay-for-play announcer (Forbes Riley) and seemed to be interviewed as an expert in stem cell therapy. She had also written a few pay-for-placement pieces in local newspapers. The message was the same. Jill Howe was espousing the amazing benefits of young stem cells in commercially available birth tissue products. The problem? These products are regulated to contain dead, nonviable cells, and independent third-party testing has confirmed that they have no viable cells.
First, let’s explore if Jill Howe is an expert in this field. This is what would define a medical expert:
- Many years using these procedures—Jill is a chiropractor who isn’t licensed to perform any procedures, let alone stem cell procedures.
- Significant basic science and clinical publications—There are no stem cell or orthobiologic research studies listed under Jill’s name in the US National Library of Medicine.
- Internationally recognized to be an expert based on training, experience, or other knowledge—Jill has not been invited by any learned conferences to speak on this topic.
Hence, Jill Howe is not a stem cell expert.
Jill’s statements from her videos, pay-for-play news-station presentations, and seminars follow:
- These tissues (amniotic fluid or membrane or umbilical cord blood or tissues) are regulated by the FDA to be safe and effective. This is NOT true. These are 361-registered tissues. They must by definition be nonliving tissues. There is no evaluation by the FDA of safety or efficacy. That would be a 351 drug approval, which these tissues lack. In fact, you or I could register a new amniotic fluid product with the FDA in a free 45-minute online process. The only thing that does is tell the FDA where they can find your tissue processing lab, and the only thing they regulate is that the lab itself is clean and the product is properly tested for contamination. You can learn more by watching my video below:
- These tissues have millions of live and functional stem cells! Jill’s whole sales pitch is that the products are loaded with loads of viable and functional stem cells that can repair tissue. Is this true? No, we have never tested any amniotic product that has any live and functional stem cells. See my video below for more details:
- These procedures aren’t covered by insurance. That is true. At Regenexx, because of the clinical data we have generated, we are getting select self-insureds to cover our procedures. Are these same large, Fortune 500 companies covering Jill’s magic dead stem cells? Nope. See our video below for more information:
- These “stem cell” injections will regrow you a new knee. While not in the main infomercial, we’ve seen countless seminars put on by chiropractors where before and after X-rays are shown. They purport to show that large amounts of new cartilage have been grown as a result of a magic pixie-dust injection (amniotic fluid). However, as my blog a while back showed, all these folks do is angle the X-ray beam a bit, which makes the joint space look bigger. I created arthritis using my own knee and then took the arthritis away in seconds, as you can see in the image below:
- For your big bucks (these procedures cost $5,000–$20,000 in our experience), you will most often get a nurse in a chiro office that injects your knee! Where is the specialty physician who uses precise fluoroscopy imaging and ultrasound guidance to ensure the stem cells will get to the right spot? That actually usually costs less but doesn’t take place at your local chiropractor’s office. See our video below of what a real stem cell procedure performed in a medical office looks like:
The upshot? Don’t fall for the flashy paid fake news interviews on TV! There are no young and healthy stem cells being delivered in magic amniotic or umbilical cord injections. This is a scam. While there are high-quality orthopedic stem cell procedures being offered by companies like Regenexx and a handful of others, most of the providers working for Stem Cell Health Centers or featured at “Stem Cell Therapy for Pain” wouldn’t be qualified to work in a Regenexx clinic or even qualify to be trained. Nor do we bait and switch our patients by offering them dead amniotic or umbilical cord tissue and calling it a live stem cell injection. Why? We invented orthopedic stem cell injection procedures for common issues, like knee arthritis, shoulder rotator cuff tears, and back/neck pain. Hence, we are disheartened when we see chiropractors fleecing consumers.
I have heard that amniotic and cord tissue products provide “fertilizer” for the existing stem cells within the joint. Thus, patients who thought they were getting stem cells (msc’s) and who reported very positive results were actually having a “repairative event” from growth factors within the amniotic/cord products. Do you agree that there are growth factors within amniotic/cord tissue that can cause a repairative event and therefore a positive outcome when injected into an arthritic joint?
The IOF tested all of this, see https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf These products do contain growth factors, but at a lower level than a standard platelet-rich plasma shot costing about 1/5-1/8 as much. These growth factors can help ramp up repair but are not capable to regrowing large stretches of new cartilage in a severely arthritic joint. The IOF also tested whether these tissues could help old stem cells do better, their data didn’t support this idea. You can call it a growth factor shot similar to, but likely less than or equal to much cheaper PRP and these injections may have other properties not yet elucidated. However, calling this a stem cell therapy is fraudulent.
Dr. Centeno
Be fair it’s not only chiropractors fleecing the innocent public, but those in you profession also, MD’s.
Definitely not only chiros, see https://regenexx.com/blog/stem-cells-not-sea-monkeys/
what about chiro offices where they do use fluoroscope guided injections. As well as have a MD and or a NP who are trained on US and Fluroscope? I have seen one that does this and uses bone marrow, cord and umbilical. They also do rehab and bracing. A lot of places are just giving patients shots and sending them home without any follow up or post injection rehab to fix the issue that led to their arthritis. No assessment or correction of loss of function that likely lead to the injury overtime.(those injuries that are not from a trauma.) Have you seen this in your experience and should people avoid clinics that do not provide rehab services and specialized assessment of the cause of the injury or preventative rehabilitation so they do not damaged the new tissue again? Or are the “shot and drop you ” clinics ok to go to?
If the chiro clinic has physicians who are properly boarded and specialize in interventional spine and interventional orthopedics (i.e. certified through IOF) and use fluoroscopy and bone marrow concentrate (not a quickie BMA system like marrow cellutions), then this could be a high-quality site. However, having said that, if that same site claims that there are stem cells in amniotic or umbilical cord products, that’s the same type of fraud whether perpetrated by an MD or a DC.
They refer to them as regenerative biologics. Would you say amnionic, whartons jelly or cord blood have no regenerative capabilities what so ever when injected into joints or soft tissue? Has there been any comparison with the effectiveness of these biologics vs high quality PRP or BMA? Does the number of stem cells that can be harvested decrease as we get older and is it true these cells actually have less vitality then younger cells? How much tissue can a BMA actually regrow in a knee? I had a meniscus repair. Basically they cut off a small piece on the corner of the inside portion and it still hurts. Can it be regrown? Is the IOF accredited at the same level as AAPM&R? It seems like a its not at the same level of recognition. I always wonder why Physicatrists are not the guys leading the stem cell charge since they can actually diagnose the functional impairments and do the corrective exercises with the patient before and after the injections? Is it your opinion that rehab is not necessary after stem cells? I have lateral patella tracking do to a malpositioning on the inside of my knee that causing friction on the inside of my knee. If that friction or malpositioning is not corrected won’t my knee just be reinjured?
Not sure who “they” is at this point in the discussion. If you mean chiros that offer “stem cell” therapy, I see advertising every day around the country through observing my local area and having ads sent to me. Most call what they do, “stem cell therapy”.
These birth tissues have growth factors, but far lower levels of the ones we know that are involved in orthopedic tissue repair than the average much cheaper PRP shot. Hence, some likely do have some positive effects on the local healing micro-environment. That’s likely similar to PRP, but nobody has tested that clinically head to head. Nobody has tested BMC in a clinical trial against birth tissues either, although IOF tested them in-vivo with older MSCs and they had a net negative effect.
I don’t use BMA in therapy as that would be a stem cell poor product (like marrow cellutions or maxxregen). I use high dose BMC. As far as “regrow”, not sure what context that question is being asked. We have seen it heal small cartilage lesions, meniscus tears, and restore damaged ACLs. It will not regrow cartilage in a KL3-4 knee, but nor will any other therapy.
On meniscus regeneration, you’re preaching to the choir. I have blogged extensively that surgery for meniscus tears in middle-aged and older patients has no research support and is likely doing more harm than good. On regrowing meniscus, I have only seen that happen in select patients with culture expanded cells, but the effect is not reliable across all patients. Our experience with autologous cells matches what was published by Vangness et al on that topic.
On stem cell number decline, that happens. However, there are few age related outcome effects in our 20K registry patients that we have been tracking for 13 years. Meaning older patients do as well as younger patients and vice versa. Hence, at least in the active elderly (which is most of the population we treat), those age-related effects don’t have a clinical impact. The one caveat is in hip OA. So as I tell my patients, your stem cells are alive and if you’re healthy and not dead yet, they work just fine. The cells in commercially available birth tissue products are dead.
On IOF, it’s an educational org, not currently offering an ABMS specialty certification. Hence, it’s more similar to SIS than AAPMR. Like SIS, it has strict entry criteria for who it will train (no NPs, PAs, NDs, and only a small subset of physician specialties).
On rehab, I’m a big believer in physical therapy and other types of rehab. Having said that, this is critical in orthopedic surgery because the procedure does damage and the rehab is needed to get the patient back to square one. In IO, the rehab is to correct the problems that caused the degeneration. So a different focus.
Do you use only bone marrow stem cells or do you also use adipose stem cells? And are you able to tell me anything about adipose stem cell repair for knees and the spine?
Maydora,
We use the patient’s bone marrow stem cells because they are the best source of stem cells for orthopedic application. We use fat for structural issues when needed, not as a source of stem cells. These explain the medical and regulatory issues in using adipose tissue as a source of stem cells: https://regenexx.com/blog/lipogems-review-fat-stem-cell-procedure/ and https://regenexx.com/blog/using-common-orthobiologics-explain-fda-1271-regulations/ and https://regenexx.com/blog/lipogems-review-fat-stem-cell-procedure/