Dubious Stem Cell Clinics

A hallmark of pseudoscience is the hijacking of words and concepts from cutting edge research, then making claims that go far beyond what is warranted by our current legitimate level of knowledge. Many charlatans use these claims to market products and services to an unsuspecting public. 

In the late Nineteenth Century, the term "Magnetic" was popular and used by many would-be healers (such as D.D. Palmer). Flash forward a century and the word "Quantum" is widely misappropriated by cranks who likely have no idea about Quantum Mechanics (such as Deepak Chopra). 

"Stem Cell Therapy" -- a term that many have heard on the news -- is the subject of cutting edge research in laboratories around the world. There has been some real progress in the treatment of certain conditions, such as in the repair of damaged corneas

As of this writing (June, 2018), the only widely used stem cell treatment used legitimately in Medicine is bone marrow transplantation. 

There is a myriad of conditions for which stem cell treatment is under investigation. However, there are currently no legitimate treatments other than bone marrow transplantation that is warranted for general use by current science. We simply are not at that level. 

However, such limitations do not prevent contemporary snake-oil salesmen from selling dubious treatments to desparate people by making unwarranted claims about stem cell therapies. "Stem Cell" is the new "Magnetic" and "Quantum" in the world of quackery.

The following excerpts are from several articles looking at the dubious business of selling so-called stem cell therapy to the public. 

As with many scams, it is sold using sciency-sounding words and riding on the coattails of legitimate science. 


Graham Parker, Ph.D., Jeanne F. Loring, Ph.D.


Buyer beware. 


Real Promise, Vastly Overhyped

"There are two main types of stem cells. Those derived from embryos can turn into almost any other type of cell in the body. Adult stem cells, specific to certain tissues, are not quite as flexible, but still serve as a kind of internal repair system.


Because of their remarkable regenerative powers, both embryonic and adult stem cells hold the promise of curing a variety of ills. Stem cells extracted from bone marrow have long been used to treat cancer and blood and immune disorders.

At least one published study shows stem cells extracted from fat tissue can speed healing of grafted tissue.

Clinical trial evidence also suggests the cells might speed wound healing, improve heart function, and treat scleroderma, said Dr. Peter Rubin, a stem cell researcher who chairs the department of plastic surgery at the University of Pittsburgh Medical Center. He is running a clinical trial to test the use of stem cells to repair severe facial wounds in soldiers.

But Rubin says any new treatments based on stem cells are years away.

And there’s no evidence yet that the cells can heal the variety of grave conditions, from stroke to incontinence to lung disease, that the clinics claim to treat — and no proof, other than the word of clinic operators, that they are harvesting the stem cells cleanly, or even harvesting them at all. 

“It’s a huge, unapproved human experiment,” said Paul Knoepfler, a stem cell researcher at the University of California at Davis who tracks for-profit stem cell clinics on his blog “The Niche.”

“What’s in the syringe? My guess is nothing helpful,” Knoepfler said. “It’s really scary to think there are thousands of people being injected with stuff, and in most cases we don’t know what that stuff is.” 






Proliferation

"Starting about a decade ago, dubious stem cell clinics were popping up largely in countries with poor regulation, like China, India, and Mexico. Their business model appeared to be to attract wealthy and desperate Westerners to their clinics with the promise of cutting-edge stem cell therapy for their incurable disease. Desperate patients would spend tens of thousands of dollars to get a witches’ brew of what was claimed to be stem cells injected into whatever body part was the problem.

The results were predictably horrible. At best patients wasted a lot of time and money on false hope. At worst, desperate families were bankrupted by the expense, devastated by the failed outcome, and often directly harmed by the treatment.

Meanwhile these stem cell clinics are making high-pressure sales pitches to their potential patients, with emotional claims based on video-taped testimonials. They pull the typical con we often see from snake oil salesmen, claiming that their many happy customers are all the evidence they need. Overbearing regulatory agencies should just get out of their way so they can get busy curing patients. They further claim patients have a right to “alternative treatments.” Many states, in fact, now have “health care freedom laws” exactly to that effect.
"




Enter the Opportunists

"The Wikipedia description of the grifters who peddled snake oil in the early 1900s has a troubling similarity to the marketing by the unregulated stem cell clinics of today. “ ...a ‘doctor’ with dubious credentials, selling fake medicines with boisterous marketing hype, often supported by pseudo-scientific evidence. To increase sales, an accomplice in the crowd (a shill) would often attest to the value of the product in an effort to provoke buying enthusiasm.”


Like snake oil salesmen, clinics claiming astonishing curative results from stem cell treatments often do not have licensed physicians administrating the treatments, no scientific evidence supporting their work, and they rely on testimonials for advertising and promoting the value of their product."



"Although stem cell therapy has a few practical applications and considerable promise, there is no reason to believe that EmCell, Medra, The Brain Therapeutics Medical Clinic, Vita Nova, the Beijing Xishan Institute for Neuroregeneration and Functional Recovery, or any other commercial stem-cell clinic are providing it as a legitimate service. Their theories and methods are simplistic; their treatments may have adverse effects; they offer no credible outcome data; and their promises go far beyond what is now possible."





The "Clinical Trial" Ruse

"In recent years, companies offering questionable stem cell therapies got the bright idea that they could describe their treatments as clinical trials, register them on ClinicalTrials.gov and thereby get some free advertising. Most stem cell treatments are not FDA-approved, and many have little or no data supporting their effectiveness, but clinics can still register their "trials" on the NIH site, making it appear that they are supported and endorsed by the government."

"What's especially worrisome is that some stem-cell treatment clinics charge patients very high fees to participate in their "trials." Some patients (perhaps most) don't know that legitimate clinical trials virtually never charge fees."


"Most patients think, mistakenly, that if a clinic offers stem cell therapy, it must have been approved by the FDA. That's not true–clinics offering these therapies don't have FDA approval, and they argue that they don't need it (which might be correct, but that's a topic for another day)."

"Patients also assume that trials listed on ClincialTrials.gov must have been approved by some government agency, but that's not true either. The site is a clearinghouse that uses the honor system, nothing more, to ensure that trials listed there are legitimate. If you read its disclaimer (but who does?), you find that studies listed on the site are not necessarily funded by NIH or approved by the FDA. What these stem cell clinics are doing is not a clinical trial, and advertising their services through ClinicalTrials.gov is reprehensible. For now, if a doctor or clinic tries to charge you to participate in a clinical trial, your best course may be to find another trial–and another doctor."





The "Cure for Everything" Ruse

There is almost nothing that these clinics won't claim to cure.

One Michigan clinic called "The Knee Institute & Regenerative Medicine" claims the following:

Stem cell therapy is beneficial in treating:

  • Achilles Tendinitis & Tears
  • Ankle Pain / Sprains & Instability
  • Arthritis – Rheumatoid & Osteo
  • Bursitis
  • Foot Pain / Plantar Fasciitis
  • Back Pain
  • Neck Pain
  • Hand / Wrist pain
  • Hip Pain
  • Hip Pain
  • Knee Pain
  • Hair Rejuvenation
  • Muscle Injuries
  • Peripheral Neuropathy
  • Shoulder Pain
  • Sprained Ligaments
  • Rotator Cuff Injury
  • Runners Knee
  • Sacroiliac Joint Pain
  • Tendinitis
  • Golfers Elbow
  • Tennis Elbow
  • Post-operative Inflammation


Again, there is no evidence that any of this is true (or plausible). 

A study in 2016 by Leigh Turner and Paul Knoepfler entitled "Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry" states:

"U.S. businesses promoting stem cell interventions claim to treat a wide range of diseases and injuries, as well as advertising stem cells for cosmetic applications, “anti-aging,” and other purposes. 

Some clinics occupy relatively specialized marketplace niches. For example, many cosmetic surgery clinics advertise such procedures as “stem cell facelifts” and “stem cell breast augmentation” as well as sexual enhancement procedures. 

Orthopedic and sports medicine clinics often promote stem cell interventions for joints and soft tissue injuries. 

Other clinics take a much broader approach and list stem cell interventions for 30 or more diseases and injuries. Such businesses commonly market treatments for neurological disorders and other degenerative conditions, spinal cord injuries, immunological conditions, cardiac diseases, pulmonary disorders, ophthalmological diseases and injuries, and urological diseases as well as cosmetic indications. Many of these marketing claims raise significant ethical issues given the lack of peer-reviewed evidence that advertised stem cell interventions are safe and efficacious for the treatment of particular diseases. Such promotional claims also generate regulatory concerns due to apparent noncompliance with federal regulations.

We also examined the prevalence of stem cell marketing claims targeted at parents or guardians of minors. We found nine clinics each promoting stem cells for autism and for cerebral palsy. We also identified 33 marketing claims for muscular dystrophy (MD), a disease that primarily though not exclusively afflicts children. 

This kind of advertising reveals another tangled knot of ethical and legal concerns, as the apparent target audience for such marketed interventions is not adults with decision-making capacity but rather the parents or guardians of children. A comparable kind of marketing situation may exist for Alzheimer’s disease (27 promoted claims) and other neurodegenerative illnesses where in at least some cases patients themselves are not necessarily the primary targets of online advertising."

 https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(16)30157-6.



Where’s the Oversight?

"In interviews, Food and Drug Administration Commissioner Scott Gottlieb and his predecessor blamed the agency’s limited resources for the lack of aggressive action in the past. Since last summer, Gottlieb has promised to pursue “unscrupulous actors” who he says are putting the promising field of stem cell therapies at risk.

The agency, which had issued only seven warning letters in seven years to stem cell clinics and suppliers, has sent two such letters since August. It also ordered the seizure of an experimental concoction made of stem cells and given to cancer patients.

Late last year, officials clarified previously murky policies to assert that many of the treatments clinics offer are unapproved drugs, a key point of contention. The facilities argue they aren’t subject to FDA regulation because they use surgical procedures to administer patients’ own cells — meaning they aren’t making new drugs.

But the agency now insists that their therapies require advance approval because the cells are intended to treat diseases and undergo substantial processing before being used in ways that are different from their original purposes.

Acknowledging the difficulty of curbing the entire booming industry, FDA officials say their crackdown will first focus on high-risk procedures such as injections into the brain, spinal cord and eye — rather than less risky ones, such as shots into achy joints.
"



"The FDA’s moves come after years of pressure from physicians and researchers who have called for a crackdown on an unproved therapy that they consider dangerous quackery. These critics say there’s no evidence the treatments work — or that some of them even contain stem cells. Yet clinics charge fees ranging from $5,000 to $25,000 per treatment, with some patients reportedly racking up bills over $100,000.

While there haven’t been many reports of serious complications from stem cell therapy, two Florida patients died in recent years after receiving stem cell injections; a California woman developed painful bone fragments in her eyelids after a stem cell facelift; and another patient developed a mucous-secreting growth of nasal tissue in her spine after undergoing stem cell treatment in an attempt to cure her paralysis."




Buyer Beware

"A number of unqualified practitioners are promoting the illegitimate use of amniotic membranes, umbilical cord blood and other products for curing a variety of ailments, including arthritis, spinal cord injuries, strokes, blindness and autism.

These claims are completely unfounded and the use of these products for these purposes is nothing short of quackery.

Leveraging a person’s desperation for a cure, or at least relief from devastating symptoms, these providers twist available scientific data to support their unfounded claims, charging patients thousands of dollars for treatments that will not work. Moreover, the insurance industry often does not pay for this care, leaving families financially devastated as well.

The most common claim is that there are living progenitor stem cells in the umbilical cord blood and amniotic membranes. Further, by injecting these purportedly living stem cells into the body, the patient’s disease or injury will be resolved.

These statements are patently false. Indeed, a small amount of live stem cells are present in placental products immediately after birth, but once the amniotic and cord products are processed, these stem cells are no longer living, and therefore offer no medical benefits to a patient.

Duplicitous clinics that offer umbilical cord and amniotic membrane injection treatments often use a bait and switch process to justify their procedures and exorbitant expenses. For example, they present a patient with studies conducted using fresh amniotic tissues but use processed amniotic products in their treatment, which will not produce the same results.


Another switch is to document that the treatment is effective, but fail to explain that the result was achieved for a different injury or condition than the one the patient exhibits. A third, crueler deception is to convince patients that they are taking part in a clinical trial, when in fact they receive dubious treatments from unqualified practitioners.

Not only are clinics providing these dangerous treatments, a growing number are marketing their practice through “amniotic stem cell seminars” targeted to draw in desperate individuals. Using the same techniques proven effective in selling time shares, there are “deep discounts” if you buy treatments during the seminar.

Most people attending these seminars are looking for help, and don’t have the expertise to ask the smart questions that will distinguish true care from health fraud.

Not only are they risking their money, but in some instances their health as well. The second reason is that nothing is being done to regulate this industry or making those providing untried, and in some instances illegal, treatments accountable for the fraud they are perpetrating on the public. The lack of regulations allows clinics to exploit a person’s fear and ignorance for their own profit."



Conclusion

Stem Cell research is a promising field. There may be a day in the future in which there are many disorders that can be effectively and safely treated with stem cell therapy. That day is not here yet. 

However, we currently have many clinics across the world offering treatments under the guise of "Stem Cell Therapy". Their claims go well beyond the current science and are therefore not justified. These treatments are not regulated or endorsed by agencies such as the FDA. The consumer will pay large sums of money -- tens or hundreds of thousands of dollars -- to receive unproven, unregulated "treatments" at their own expense, often under the guise of a "clinical trial". No legitimate research organization charges participants to participate in clinical trials.

These treatments have unknown risks and unproven benefits. They are marketed with fancy websites, testimonials and expensive dinner seminars by providers -- some of whom are actual MD's or DO's and should know better -- with no regard to scientific standards or ethics. They will use scientific-style jargon and promise miraculous cures for just about anything that ails you. This is a scam.

Unfortunately, these charlatans will poison the well for future science-based, legitimate treatments by legitimate providers. 

This is truly a "buyer beware" situation. For now, save your money.



John Byrne, MD


References

McFarling, Lee Usha . "FDA moves to crack down on unproven stem cell therapies - STAT." Last modified 2016. Accessed 5 Jun 2018. https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/

Novella, Steven and MD . "Stem Cell Tourism Comes Home – Science-Based Medicine." Last modified 2018. Accessed 5 Jun 2018. https://sciencebasedmedicine.org/stem-cell-tourism-comes-home/

Parker, Graham, Ph.D., Loring F. Jeanne and Ph.D. . "Protect Stem Cell Science from Stem Cell Quackery Keep the Opportunities, Lose the Opportunists ." Last modified 2016. Accessed 5 Jun 2018. https://www.genengnews.com/gen-articles/protect-stem-cell-science-from-stem-cell-quackery/5820

Barrett, Stephen and M.D. . "The Shady Side of Embryonic Stem Cell Therapy." Last modified 2015. Accessed 5 Jun 2018. https://www.quackwatch.org/06ResearchProjects/stemcell.html. Salzberg, Steven. "Stem Cell Clinics Are Advertising Their Treatments As Clinical Trials. They're Not." Last modified 2017. Accessed 5 Jun 2018. https://www.forbes.com/sites/stevensalzberg/2017/07/24/stem-cell-clinics-are-advertising-their-treatments-as-clinical-trials-theyre-not/#77940ba96b03

Turner, Leigh and Knoepfler Paul. "Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry." Last modified 2016. Accessed 5 Jun 2018. https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(16)30157-6

McGinley, Laurie and Wan William. "Miracle cures or modern quackery? Stem cell clinics multiply, with heartbreaking results for some patients. - The Washington Post." Last modified 2018. Accessed 5 Jun 2018. https://www.washingtonpost.com/national/health-science/miracle-cures-or-modern-quackery-stem-cell-clinics-multiply-with-heartbreaking-results-for-some-patients/2018/04/29/80cbcee8-26e1-11e8-874b-d517e912f125_story.html?utm_term=.f558ec59dd91

McFarling, Lee Usha. "FDA moves to crack down on unproven stem cell therapies - STAT." Last modified 2016. Accessed 5 Jun 2018. https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/

Russo, David. "Columbia Pain Management's David Russo on why patients should beware of stem cell quackery - Portland Business Journal." Last modified 2017. Accessed 5 Jun 2018. https://www.bizjournals.com/portland/news/2017/11/20/patients-should-beware-of-stem-cell-quackery.html.