You can go to pubmed and search on "stem cell transplant for joint disorders in humans".
You find things like this:
https://www.ncbi.nlm.nih.gov/pubmed/27365460
https://www.ncbi.nlm.nih.gov/pubmed/28258177
Long story short: these injections are not recommended by researchers at this time. Outcomes can include acquisition of Epstein Barr virus, among other negative results.
40
Rafael Nadal had stem cell therapy done on his back and knees. He is still playing tennis at a high level but he did say that he sometimes still has pain where the tendons are close to or attached to the kneecap.
11
Because of my experience with a different form of stem cell injections not mentioned in this article, it occurred to me to provide additional information worthy of consideration.
Having had meniscectomy on both knees, multiple cortisone injections plus physical therapy, I was offered knee replacement surgery. I couldn’t bear another surgery so opted to look into alternatives.
I learned of a reputable physician who did stem cell injections. She ordered an MRI of both knees and the results would determine if I might be a candidate. She also explained that stem cells helped some but not everyone who receives them.
She told me about PRP, bone marrow, and amniotic options for stem cells and, in my case, felt the amniotic stem cells would be the best option.
I opted to try.
In December 2018, she injected amniotic stem cells into both knees. The amniotic stem cells slowly work over a 6 to 9 months period of time. I have found this to be true.
For me, I have steadily felt better and am now walking without pain. I even walked up a hill with walking sticks and only needed help for one large step on the way down (about 2 months after injection). I am elated with the progress and am 5 months out from the injections.
The cost, $5000, for both knees which is sadly prohibitive for many. I hope for continuing regeneration so I can continue to live my life without knee pain or surgery.
30
The part that I find most concerning is the end run done around the system, in which the clinic owner is selling the procedure directly to companies for their employees’ “benefit”:
“ The company [Meredith, a large publisher] estimates it would have spent $1.6 million if those individuals had knee replacements, compared with the roughly $400,000 it paid to cover the Regenexx treatments...Another Iowa company, Hy-Vee, the supermarket chain, is now requiring workers in some locations to get a consultation from a doctor who offers Regenexx before being eligible for a knee replacement.”
So now, the upper management of a company (which cannot be assumed to have any medical knowledge) has a strong financial motivation to offer an unproven therapy to its employees in lieu of alternatives which have been more thoroughly vetted (ideally) by the FDA. That sounds like a recipe for disaster, regardless of whether the management’s intentions are sincere or cynical.
Even worse, it sounds like an effective sales strategy that others can easily follow.
62
Attributions like "claims" and "contends" are red flags for reporter bias. I have had two Regenexx procedures: stem cells for a badly torn rotator cuff (100% recovery) and PRP to calm a nerve irritated by a bulging disc at L5/S1 (much slower than a steroid epidural, but it worked). I don't "claim" or "contend" those outcomes. I say it, and I stand by it. The stem cell field is indeed full of snake oil operators. But Regenexx is an example of developing these therapies to the highest possible standard. The company doesn't deserve the snarky comments and doubt-drenched attributive verbs.
25
Whether in politics or science, as the comments here show, personal anecdotes are viewed as more valuable that actual data. This is why we have deniers of climate change and anti-vaccine "advocates." This is the sort of reporting that distinguishes the Times. Kudos.
69
Expensive medical treatments profit the corporations that own hospital networks which now control our health care and insurance payment structures. These corporate owned stem cell centers are profiting the hospital corporations. Insurance companies don't cover them which allows the hospital corporations to bypass insurance pay structures and denials thereby the patient is charged out of pocket and billing much easier. Unfortunately the average patient doesn't know this. If you have money to pay out of pocket you can bet they will hood wink you.
6
Stem cells, Artificial Intelligence, Quantum Computation, data based market efficiencies saving customers money; all nice ideas, but if they ever start working in concert, people will reincarnate (rejuvenate) themselves with super powers. But, we've already demonstrated that we cannot be trusted with normal human powers.
I'm hoping for universal rights to food, safety, and health care, instead.
25
Having worked in medical device/biologics regulatory compliance, I can assure you that the FDA is not a high benchmark for regulatory oversight. The general application process of a biologic product can be described shortly as "is it safe and effective?" Regenexx has been able to demonstrate in case studies and collected reports that the incidence of adverse events is lower than surgical alternatives while providing a significant degree of relief compared to placebos. When compared to conventional surgical repair methods, i.e. arthroplasties, the biologics provide similar metrics of relief but with lower incidence of a second intervention being required. These are studies involving less than 100 subjects, but nontheless the data is statistically rigorous.
On the uninsured issue, I recall from my time working at a clinic associated with Regenexx that patients enjoyed how the cost was upfront and transparent, whereas insurance-covered procedures were completely veiled to the patient until the procedure was complete and the insurance company had processed it. With opportunity cost, the patients saw the faster recovery times and thus a quicker return to their sport. Given a copay could go into the 1000s easily, trying a PRP first is a good bet for most.
Furthermore, to lump Regenexx in with the gray-market biologics companies that are injecting into the eye and other dangerous areas with no empirical data is like lumping a chiropractor with Robert Kraft's Thai massage parlor.
23
I had the "stem cell" treatment described herein. I am in my eighties and had been in constant pain for years. Four months after the treatment, I am almost pain-free, with more mobility and flexibility. Anecdotal, sure. but I felt almost compelled to share because the anti-stem cell articles like this one tend to be biased and treat stories like mine with great skepticism.
On the other hand. I have observed many friends and acquaintances who had hip or knee replacements and/or back surgery and are still have serious mobility issues. I, personally. know at least half a dozen cases where the surgery had to be redone. Why not try something less invasive, less painful and less expensive?
29
I had the stem cell treatment at The Darrow Clinic in both knees. I am pain free and exercise every day. I paid what I consider a fortune from my retirement fund on this procedure and it worked. No replacements are needed. I am 68.
23
I am one of the individuals who benefited greatly from stem cell treatment in my knee. Before treatment I could barely walk, now I can hike. X rays show increased cartilage growth after receiving the stem cells.
18
Why is the FDA not doing it's job but allowing this medical fraud? 80,000 people have died from medical devices that the FDA still hasn't pulled from the market place, and several thousands more injured.
16
I'm a little puzzled as to why platelet-rich plasma (PRP) is lumped in with stem cells here, as a sort of afterthought. My wife (age 71) had inflammation of the Achilles tendon, which the doctors told her was untreatable and would result in breakage of the tendon. She tried PRP. The cost was $875 (no insurance coverage) and she said it was the worst pain she had ever experienced. But it's been one month since the treatment and the tendon is greatly improved, with no pain, and the swelling much reduced. We'll see.
22
Stem cells have long been known to reduce inflammation and the improved joint symptoms people experience is evidence of that effect. But, stem cells are advertised, blatantly, as "regenerative or restorative" for which there is little evidence. Store front practitioners advertise stem cells as curing baldness, impotence, spine degeneration and a wide spectrum of disorders, all without scientific evidence. One should never accept stem cells unless they are part of an approved clinical trial.
12
Professional sports teams are usually well in front of mainstream medicine (and insurance) and they don't waste time on treatments for their biggest assets (star athletes) that don't work. While studies do need to be done to better document where in the body these treatments are effective and where their probability is low enough to not recommend it, insurance companies need to catch up to the real world and start covering it. If insurance was the determining factor for whether treatment was effective or not, no one would be getting dental implants either. Ironically by not covering stem cell and PRP treatment, their insured is likely to become more sedentary or want more expensive and invasive surgeries and cost them more in the long run.
8
@Kevin
Actually, your premise is totally false. Professional sports teams use all sorts of practices in training, recovery, sport rehab, and so on including medical treatments which are not validated by science research.
11
@Kevin thank you insurance, ortho surgeons and AMA... way to protect your turf and keep the public controlled and perpetuating your profits
3
It all depends on whether your issue is one that is addressed by using stem cells, and very much on the skills of the doctor doing that procedure. The man who invented the first machine for concentrating stem cells out of bone marrow, back in 1992, is a friend of mine. He started using it on competition horses, and treated Ravel, who had damaged a tendon just weeks before the Olympics. Ravel medaled in dressage.
January 2003 I was told I needed knee replacements. There were days I couldn't walk. Or sleep. Knowing stem cell treatments existed, because of my friend, I took diclofenac and suffered, waiting until the procedure was available in the US from a competent practice. Got my stem cell injections Feb. 2018, at Virginia Spine Institute, which treats the Washington Redskins. Team owners don't take chances with multi-million dollar players. I had no pain, none. Walked out with just 6 regular bandaids. Haven't taken any anti-inflammatories or used any knee supports since. Last month I climbed on glaciers and a volcano in Patagonia.
Just don't go to any quacks!!
33
Three Signs of a Medical Fraud:
1) Newspaper Ads and Sponsored Content
2) Not covered by insurance
3) Only available in Pain Clinics
59
“They’re really quick to try to give you fake joints and make a bunch of money off you,” he said.
But joint replacements work, obviously...and then he spent $6,900 on an unproven treatment? Fascinating.
29
@Phil totally what i thought. Yes, of course hips replacement is more invasive, BUT - it's covered, and today's techniques are not only proven, but recovery is really quick for people like this guy mentioned - those that are healthy/in shape. I know knees are a different story, but that guy's story struck me. Not sure if it's the right approach.
Knees of course are really different. Stem cell sounds fairly promising, but it's obvious there are large scale trials and a "dialing in" of the procedures needed. Unless i'm at my wits end, i'm waiting on
the sidelines on this one.
6
I have a therapy for you and I won't charge you a penny. I have a genetic defect that means my knees are misaligned and the cartilage well worn. They hurt and get dangerously weakened, making going down stairs a challenge. My wife, who is excellent at these things, prowled the Internet looking for a natural remedy and here is what she came up with: a glucosamine-rich broth that you add to soups and stews and eat like a nutritional supplement (e.g., a serving every day). The results are miraculous: my knees get stronger, they do not hurt or grind. My thumb, which is arthritic due to an injury, stops hurting and I get most of my range of motion back. The difference is night and day. Here is the recipe:
-- 2 lbs of "patas de vaca" (cow hooves and shin bones, to be purchased at a carníceria -- they have them all the time). Be sure they include a couple of hooves because they have a layer of tissue that is pure glucosamine.
-- A six-inch long piece of yucca root, peeled and sliced (it's anti-inflamatory).
Place in a stock pot, cover with six inches of water and simmer for 18 to 24 hours. DO NOT GO LIGHT ON THE SIMMER. It takes that long to leach all the good stuff from the bones.
Remove the bones and strain out all the solid bits, but be very careful to leave the slushy bits in the pot. Blend with a submersible blender until consistent and smooth.
You are making a healing gelatin that works miracles because this form of glucosamine is easily absorbed. Just try it. ¡Buena suerte!
15
@Brian Prioleau, you might want to look into an Instant Pot to turbocharge your extraction process. I’ve been making chicken stock the traditional way for years (for culinary purposes). When I made a batch in the pressure cooker, I was amazed at how much more gelatin ended up in the final product, with a much smaller investment in time and energy. Also, I have seen many recipes that call for the addition of a small amount of vinegar, which is said to increase the efficiency of extraction of the good stuff (minerals in particular, if I remember correctly).
13
"Dr. Centeno argues that the vast majority of orthopedic procedures performed today by mainstream physicians do not have any evidence that they work. Indeed, studies in recent years have challenged the value of many knee surgeries performed for torn cartilage."
So the unscientific, but highly profitable, orthopedic mainstream challenges premature “stem cell” entrepreneurs’ lack of science. How about a similar article confronting the unethical surgeries, with proven lack of efficacy, pushed by this establishment?
24
Similarly, the FDA should have every patient sign an FDA summary outlining the lack of efficacy of the many orthopedic surgeries that are foisted on large numbers of unwitting patients.
13
I had stem cell therapy to accompany removal of a loose body creating a fissure in my articular cartilage. I'd also torn my meniscus hyper-extending my knee while running. Five months later, my knee feels strong, no pain, and I'm running again. I'm 57 and have been running more than 30 years. I don't plan on stopping. I plan on getting PRP for the right knee (which shows mild degeneration) in a few weeks. I've looked at all the research and had an excellent orthopedic surgeon in San Diego perform it. I believe these types of procedures in the right hand holds promise for the future.
18
"The thing that separates humans from other animals is the desire to take medicine."
7
@Rawiri, my dogs are constantly asking for the “medicine” that resides in the pantry. It’s shaped like gingerbread men and is flavored with peanut butter. They they need four doses per day.
22
"The thing that separates humans from other animals is the desire to take medicine."
1
I loved the feedback from the comments, great data. I really like the article statement “This is how snake oil has been sold for generations.” We must become wise enough to avoid snake oil even though the insurance companies with pay, eventually U do pay. That is a great part of what is wrong with healthcare in America, a lack of mutual sense of responsibility. Singapore has a much better idea, your individual health care payment account pays for all medications and even hospitalizations so you are vested in the process, each dime that you incur in expenses come first from your accrued savings in that health account.
I do hope that Gretchen Reynolds of NYTimes Well does cover this as it is well worthy of more dialogue. I am a fitness buff but I never do long runs, I am pushing 80 and I exercise with the teenagers and twenty-somethings. Running kills joints and upper body muscle mass. Most important, I LISTEN to My Body. I crack my joints to make them pop each morning so that I have greater agility. It works for me. I lost the ability to pop my right knee after a trip to the US. I kept at it for 3 months, finally it is back. I flex like crazy so that my muscles stay balanced.
I loved @Knitter In the last 3 years, I've lost 150 pounds, started working with a trainer, become more active and my pain has decreased. There is your cure, Ladies and Gentlemen, move and get good real physical help, not snake oil. Really workout, not a dress up to be seen.
Peace
9
The stem cell injection "industry" looks like the perfect P.T. Barnum story befitting of our times.
16
I have been practicing rehabilitation medicine for over 30 years. It never ceases to amaze me how many physicians are out trolling for patients to perform procedures on and how many patients are willing to undergo them. Many well accepted and high volume orthopedic surgeries provide far less benefit than the medical community and general population assumes, especially with shoddy patient selection. A few years ago at a conference I asked purveyors of "regenerative medicine" to explain the science of it to me. The could not. Blood soup.....ugh.
23
@AY as a rehabilitation physician, I am sure you are aware of the paucity of research in ALL of musculoskeletal medicine, including corticosteroids and especially surgery. The best research we have is for PT and exercise, but what happens when more is needed but patients want to avoid irreversible and perhaps unsupported surgery? The truth is that orthobiologic literature has expanded exponentially over the last several years, to the point that the science can, in fact, be explained more thoroughly, albeit not fully. You just have to ask the right people.
Unfortunately, you are absolutely correct that there are a LOT of clinics that are trolling patients when they do not know anything about the science let alone how to implement it effectively.
If you are interested in learning more, I implore you to look into the literature and perhaps visit conferences of such organizations as the Interventional Orthopedics Foundation (IOF), The OrthoBiologics Institute (TOBI), and the American Association of Orthopaedic Medicine (AAOM). Even rehabilitation specialty organizations such as AAPM&R and AOCPMR as well as Sports Medicine and Interventional Pain organizations have all highlighted orthobiologics at their conferences.
11
There's a word for using medical therapies that lack evidence of their efficacy:
"Quackery."
Unless these "clinics" are part of some kind of randomized controlled therapeutic study, they should be presumed to be peddling hokum and quackery until proven otherwise, and should be shut down and prosecuted accordingly
29
@Anonymous Bosch well said, I endorse your comments & wonder people in this highly educated society have some habits of those living in the era of thousands of years ago ! Perhaps it may take another 100 years to improve the concepts & beliefs.
4
15 years ago, Democrats fought to use the stem cells of aborted fetuses claiming that doing so would cure many common diseases. Turns out it didn’t. Now Democrats are touting Climate Change with the same fanaticism. Will Climate Change turn out to be a bust like stem cells?
4
@Rick. Let's be fair here. Are you a stem cell expert? Were stem cells from aborted fetuses ever used in federally or state funded research? No. So leave the Democrats out of it, and leave climate change out of it. Sheesh.
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@Rick
15 years ago the democrats were doing no such thing except in the fevered imaginations of the fiction writers at fox news and newt gingrich incorporated.
76
Crazy how much a placebo costs these days. The emperor has no clothes.
24
It's sad to think about how the F.D.A. has been so hen-pecked due to the effect of corporate campaign donations. Once, it was a shining light - a place that truly worked to protect our public health. Now, infiltrated by revolving door "professionals" - who go in and out from "regulating" the industries by working at the F.D.A. to working in them themselves - and funded in great part by those industries as well- it's a mere shadow of its once pretty good self. Under-funded, bombarded on all sides by charlatan get-rich-quick schemes and industries, it - and many of our other government regulatory bodies- are pale shadows of what they were in the pre-Reagan years.
34
"Regenexx was started in 2005 by Dr. Christopher Centeno, a pain medicine specialist in Broomfield, Colo., who had no background in stem cell research, but saw potential after reading about a study that hinted that stem cells could be used to treat spinal conditions in rabbits." What could possibly go wrong?!
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@Joseph
I do not see how any of the procedures described here deserve the fashionable label “stem cells.”
7
@Joseph, “I’m not a doctor, but I play one on television.”
7
The quote that stem cell injections can't make your condition worse is incorrect. I was told I needed a double knee replacement and tried the stem cells after the doc told me that the procedure couldn't make my condition worse.
Well, a year later I am still in intense pain (both my legs, not just my knees now) that makes walking, sleeping, living difficult. My pain management doc (yes, on pain medication now) doesn't think I should have surgery after the terrible reaction I had to the stem cells being injected.
I'm doing physical therapy and taking pain management classes offered by the hospital for cancer patients.
The doc who did the stems cells told me he had NEVER seen the reaction I had...
62
Many joint procedures are marketed in (private) veterinary medicine before they become available to humans. They can be big money makers for the vet. About ten or a dozen years ago my vet (at the time) pushed hard to sell a stem cell procedure for my elderly dog. He claimed it was just short of a miracle, and that it would renew her badly degraded hip joint to such a degree that she would be running like a puppy. The cost was somewhere north of $6k. I was skeptical due to the blatant oversell, and was further out off my the fact that previous to this he had tried to sell me a total hip replacement and a spinal disc injection of an enzyme (which would have dissolved what turned out to be an intact, problem-free disc). I moved to another vet. But I wonder how many clients were fooled by that vet’s con job.
28
Saw a guy in the pool at the athletic club doing real annoying dance step in swimming lanes. In the locker room he explained it as prescribed exercise after his stem cell shots.
Humans will never stop searching for the fountain of youth.
I had some steroid shots in my lower back 30 years ago that made me jump off the operating table like Ralph Boston.
Both Chickenmerde and chicken soup will be sold and served in our crazy new world, so how will we ever know?
Tests.
Call me back after the trials.
Meanwhile, we've got six cases of brain cancer in the small town where I live, from people who spent their lives on the computer.
The big questions never stop. & Asking is so much easier than answering.
13
@frankly 32 What is interesting, these aren't stories about someone going from having to use a wheelchair or walker to go shopping, and the injections let them dump the equipment. As far as I'm concerned, this is an expensive placebo for aging amateur Boomer athletes wanting to relive their 20 something PRs.
After my car accident, I asked my orthopedic surgeon how long should I wait before surgery.? He told me as long as humanely possible. He's put 3 kids through Ivys debt free on the knees and hips of 50 something amateur athletes. Why semi snake oil sell? Because Boomers think they will live pain free and forever, and never take no or conservative care for an answer.
7
@frankly 32
I won't take up your "swimming" lanes (specially constructed water?) because my pool dedicates those lanes to whatever you need them for—swimming, jogging, or walking. Water walking, which can occasionally include some simple dance steps, is a wonderful way to get exercise when land walking is too painful. The water is also a great place for badly disabled people to exercise.
23
It's pretty scary that some doctors, with years of education and experience, are out there to perform procedures that are not proven or data-driven, just to make a quick buck.
35
@Brian, yep. I go to a med spa run by a Harvard-trained physician. She recently added a procedure that combines micro needling with the patient’s own, centrifuged plasma (“platelet rich plasma”). I was horrified and disappointed when I learned that. She used to be more conservative about her offerings! But there is a lot of money in such enhanced services. In my region, you are talking well over $1k per procedure. And clients are usually told that they need more than one treatment.
14
@Brian People might be surprised by the number of come-ons docs get via snail mail. e-mail, etc. to make money. The type of come-on you get depends on your area, specialty, etc. Some are legitimate -- as a geriatrician, I get invites to assisted living facilities to consult/ refer my patients; mail from home health providers, etc. -- while others are obviously not beneficial and even harmful for patients just to make a quick buck.
13
@Passion for Peaches My ortho doctor has always been a straight shooter with me. Almost all his suggestions have been wait/see and physical therapy. Conservative treatment is a ton of time. The person training for the ultra marathon or triathlon doesn't want to hear that. So my doctor does all the other throw it against the wall and see what sticks with them.
Their out of pocket, semi placebo procedures off set this doctor's sliding scale fee he gives to patients who could never afford him.
8
To all those commenters swiftly dismissing personal experiences of success with these treatments—“placebo!”—please take a step back and show a bit more respect. Yes, stem cell treatments need rigorous study. Yes, they may actually prove to be ineffective. However, they may also prove to be highly effective for certain patients. In the latter case, those of us who have enjoyed successful stem cell therapy will have unjustly been mocked as suckers falling for snake oil.
There may be unethical doctors pushing this as a cure-all free of risks, but the ethical ones present it as exactly what it is: an experimental new treatment whose efficacy is uncertain. Anyone who has struggled (as I did, ages 20-39) with a debilitating health condition will be open to trying something experimental when conventional treatments have miserably failed. The paltry specks of anectodal data from our experiences do not prove that stem cell therapy works. But they do deserve a respectful hearing instead of derision.
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@Emma
What's wrong with placebo?
It's been proven to work over and over again, that's one of the reasons why medicine is an art, not an exact science.
13
@Emma
Any medically sophisticated intervention should be subjected to strictly controlled clinical trials that facilitate a statistically meaningful comparison with the standard of care, before offered to patients. Companies trying to get around this do not deserve the benefit of doubt.
11
@Emma
1) The placebo effect is strong and not to be dismissed. HOWEVER, placebo is unpredictable and we can't tell who would benefit for it vs. who would not. Also, new treatments are tested against placebos (or the standard of care for a specific condition) all the time: the treatment has to perform BETTER than the placebo (or the standard) to be approved. In some cases of medication, some performing equal to the standard can be approved.
2) Even more important than the effectiveness of a treatment is harm. Most of the public focus on the former without thinking of the latter. People are so hopeful for a treatment or cure. The first rule of medicine is do no harm. It is better to do nothing for a patient than to injure or kill them with a treatment. Without studies, we do not know if there is harm, how much harm there is, who is harmed, etc.
3) I work with a lot of patients with incurable, degenerative conditions. I tell them that just because someone is nice, well-meaning, or ethical doesn't mean they are right, intelligent, or up to date on the latest treatment. Snakeoil sellers KNOW they are doing wrong to make money but there are also people I see who think they are doing right by their patients but are too blind to see they're wrong.
4) I also educate my patients that most scams have a kernal of truth. Otherwise, people would not fall for them so easily. However, the truth may only be 5%, 10%, etc.
18
I have never seen such illogical thinking.
The absence of clinical tests does not indicate that a treatment does NOT work, only that it has not yet been proven TO work.
It is idiotic to label untested treatments as snake oil until they are tested and shown to be inneffective. Stem cells and PRP could very well be effective treatments. They are certainly not as dangerous, painful and risky as knee replacements.
30
When Orthopedists refuse to operate on someone, consigning them to a lifetime of pain or drug addiction, what other options do you have to offer them? Until joint replacement is not considered "elective" surgery for "lifestyle choices", and arthritis is understood as the debilitating, soul-sucking disease that it is, as handicapping as a broken bone, people will, out of desperation, try whatever options they can get.
15
@Samazama - I am an orthopaedic surgeon and decision for surgery is made with shared decision making between me and my patient. Not everything can be made better with surgery. There are risks and benefits to consider. Many times, losing weight and doing PT before surgery reduces risks of surgery and makes the surgery more successful. Sorry, surgery is not something that you can order as you would order a meal in a restaurant. When surgery is declined - usually there is a good reason.
28
The thing about medical treatments is that if they go wrong, they go very, very wrong. Remember the thalidomide tragedy where thousands of babies were born horribly maimed because their pregnant mothers took a drug that was "approved" in Britain. The F.D.A. saved American mothers. Sometimes medical treatments need scientific clearance through blind, third party studies that prove their safety and value. It is always great to hear of break though medical news...a new drug or treatment that will save many souls. But medicine is based on science, not rumor, and we need an aggressive F.D.A. to protect consumers from fad medicine. If you don't think doctors, or clinics, or hospitals would stoop to using fragile patients as test subjects, you would be wrong. Money and fame drive people to do many cruel things. Look at what our drug manufacturers are doing; making their wealth on oxycodone and charging inflated prices for life saving drugs. There is no end to greed in America today. It does not stop at the clinic door.
26
A significant income stream may disappear if these treatments are proven worthless, but a an even bigger income stream will disappear if the treatments are successful.
At $32K a pop, replacement surgeries are a cash cow, particularly with an aging population. A $7K alternative, if it works, is very attractive.
The dilemma we face is a medical industry (particularly pharma) unwilling to invest in research for options that are less costly than current treatments. Why should they shoot themselves in the foot?
But among those unproven treatments may lie some that save not just money, but also lives. Replacements hips may be improving but, as Marvin Gaye and Tammi Terrell sang, 'ain't nothing like the real thing baby.'
10
@Justin It is telling to me that the FDA generously (if wrongly in my opinion) gave 3 years for these companies to do their work with little scrutiny and then submit their data but hardly any company has. If their treatments truly work, they would submit that data and get it legitimately approved rather than hiding it in the shadows.
I have consulted for the FDA in a situation outside of stem cell research and it has been eye-opening to see what companies can do to hide or distort date to get something approved. In the case I was involved in, patient deaths were not reported accurately and yet the company had the audacity to pay/ use patient advocacy groups to attack the FDA for not approving this drug. The patient deaths by the way were known by the advocacy groups but they chose to ignore that piece of information.
(Would I be surprised if some of the people writing in touting success of stem cell transplants were hired by the companies? No.)
18
Both AC and PRP for knees and joints are also being tested by May Clinic. So are you suggesting that they are bogus? Over a year ago, there was an article in the WSJ about these procedures and that they were being tested at Stanford in CA and Spaulding in Boston. Also prestigious institutions.
Additionally, once a patient replaces their knees or hips, they have no other option, but to replace again if necessary in the future.
I am suggesting that any patient should go to just anyone. But MAyo Clinic is also or was doing a clinical trial on that.
So why note? From a well-reputed institution.
Thanks
7
@Smita. It happens that “respected” institutions are sometimes drawn into serious study of all sorts of medical effects not because they have a great deal of interest, but because the public has developed interest, and it is unfortunately necessary to do studies simply to inject a bit of reality into both public and institutional discussion.
In most cases, this is scarce research effort and expense wasted, for two reasons: First, we could be studying other, more promising subjects, and, second, once the public gets indoctrinated by marketing, sensationalist articles and books, we become quite hardened in our new faiths and tend to be resistant to science. Autism and vaccines, to take a current awful example.
So, if the Mayo Clinic does their proper thing, it’s guaranteed that the effect on the hopeful and already convinced will be minimal, regardless of the outcome.
Actually, snake oil, from real snakes, has a very long history in China and Japan. Sounds good to me. Snakes move really well.
9
@Smita. The Mayo Clinic did indeed find positive effects from stem cell treatment in their study.
http://medprofvideos.mayoclinic.org/videos/mayo-clinic-uses-stem-cell-therapy-to-treat-arthritis-in-knee
I looked into Regenexx almost 2 years when my (first) hip went bad. Dysplasia and decades of running did me in, I could barely walk or get to sleep. I decided against pursuing it for several reasons:
- no studies of long term results. This was critical. If I ended up requiring a hip replacement in a “few years”, would I still have insurance for the surgery then? Yes, my policy $$ is through the roof, goes up every 6 months, so who knows. Surgery meant results.
-if it didn’t work, $7k down the drain or possibly dropping another $7k on a second round (oft times recommended)
As it turned out, my THR was $50k and even with BCBS, I paid thousands out of pocket! I experienced iatrogenic complications from the lumbar puncture which have been debilitating. The new joint is flawless and I was driving in a week. This July, I’m scheduled for the other hip - it’s going south quickly, affecting my daily function.
I do see potential for a variety of stem cell procedures. It maybe the future of medicine, but sadly, not likely in my lifetime. If I had deep pockets, I’d try it.
4
@Smita
Being in a clinical trial at a well-respected institution is very different from going to a for-profit clinic that is selling the process for money. In the former case, researchers are careful about being honest with patients about the pros, cons, what is known, what is unknown about a treatment/ procedure. Success much less certain assignment to the treatment rather than placebo group is not guaranteed. Often research is covered by external funds and subjects do not pay. Researchers are also bound ethically and by various rules to report what they find, good or bad, and publish the results eventually.
Also, researchers are usually careful about claiming success of a treatment based on one or even a few studies. It's the aggregate of studies and data upon which good decisions are made.
Finally, having worked at different large institutions, they're not necessarily immune to hype or $$. There have been times when I wonder about the wisdom of this or that medical center touting or advertising a treatment, test, etc . which has not been confirmed yet, for which safety is questionable, or where the cost far exceeds the benefits.
8
There are doctors who believes that stem cell treatment can also be given to sickle cell patients and that the treatment works to rid these patients of that wretched disease. These are respectable doctors that I know.
2
@Tonjo
That is essentially correct, but the stem cells also need to be treated using gene therapy prior to being reinfused. That DOES work, but for different and more complex reasons than the cases discussed in the article.
It is very different from what the article is about.
13
I had stem cells put in my knee after years of pain. Guess, what, worked 100% and running ultra marathons again. It's the only treatment that worked. Hands. Down.
19
People like me are seeking a bit of hope. Our hope is to improve our quality of life by reducing pain and maybe even improving function. Solutions often aren't coming from prevailing treatments. In my case recommended treatment involves replacing both shoulders: starting with a bone saw and a box of prosthetic parts that may last 15 years.
Ideally we would have a mature, well-regulated suite of therapies with quantified risks and efficacy to fill the vacuum created by current orthopedic best practices. In the meantime, we hope, and if we can afford it, explore options beyond conventional western medicine, and for some that includes experimenting on ourselves with unproven solutions.
6
As a Professor of Medicine and Rheumatology at a top tier Medical School and Hospital, I urge caution and am ashamed of colleagues who are doing this "treatment" because financial gain is currently the only reason to do it. There is a well documented substantial placebo effect from putting a needle in someone's joint, so any anecdotes or non-blinded trials only demonstrate the procedure produces relief (the placebo effect), NOT the stem cells. If this were a medicine to be approved by the FDA, it would require two pivotal blinded, placebo controlled trials, none has been done or published.
The American Academy of Orthopedic Surgeons already noticed this with related viscotherapy injections, and recommends they not be given.
Our county is facing a huge wave of osteoarthritic knees and hips as the baby-boomers enter their arthritis years. We need all the treatments we can get to overcome this, but Stem Cell injections are not yet one of the proven treatments we need.
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@Calvin R. Brown Jr, MD
Dr. Brown, are you working with your medical school to get funding for clinical trials?
Please do that.
4
@Calvin R. Brown Jr, MD More concerning are the equity issues. In a two-tiered health care system, the masses will get corticosteroids until their arms and legs fall off, while the elites get autologous orthobiologics.
8
My wife and I are both suffering from osteoarthritis. We attended a seminar on stem cell therapy and came away with the feeling that we were being sold a timeshare. After over thirty years in the medical device industry in cardiovascular implants I was shocked that so little clinical study has been done on this therapy. After the presentation a flock of cute young girls were signing up people for an evaluation. For now I will wait and let the science catch up to the hype.
81
They might want to factor in the placebo effect.
12
Any story about a medical procedure or new drug elicits the full medical histories of half the readers in the comments.
Ironic that patients do a better job selling snake oil than the doctors do.
11
@mediapizza. Testimonials are effective marketing aids, and have been for a very long time. It is also interesting that things like Amazon’s reviews or Yelp move anecdote into the territory of seemingly meaningful statistics. Thus ‘Nine out of ten doctors prefer Cigarette Brand A’ now becomes ‘452 users of Huile de Serpent rate it five stars.’ If George Carlin were still with us...
9
The man at UC Davis is correct, until the efficacy of these treatments are known, no charges to patients are rationally justified. It is rational to conclude that the treatments offer nothing in the way of affecting the ailments until it can be proved that they do. Charging any money at all is selling hope not medicine.
25
As someone who was treated in Wayne for stem cell I find this article extemely misleading and partially inaccurate. I have had two stem cell treatments and PRP after having multiple traditional knee surgeries. I could not function in a normal way before the stem cell procedures and I was 34 at the time. I am currently forty and my life is completely different. I was told I would have knee replacements by now prior to the stem cell.
To suggest this isn’t real is dangerous. Knee replacements are dangerous and have been shown not to work. What 34 year old wants to have three rounds of knee replacements in her lifetime? Should stem cell be regulated? Sure, but to outright suggest it doesn’t work is wrong. As a nation we are encouraging replacements at epic proportions at earlier ages and you can see this from previous nytimes articles. Replacement procedures do not have great outcomes and are considerably more dangerous than injections. To the writers of this article I am frustrated at the suggestion that this isn’t real. Do you know what it is like to not function at 34 and to be in so much pain. I would have tried most anything except cutting my bones off and replacing them with a plastic/metal joint.
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@SL
You experienced relief. A large proportion of ailments improve without changes in treatments which did not help much for very long time periods. There are many studies that show real improvements in patients given placebos. The bottom line is that without controlled studies over rather long periods of times, the real value of these treatments cannot be determined.
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@Casual Observer
It has been six years I had to go down stairs backwards.
I am now able to lift weights and I carried a child without pain in my knees.
I don’t disagree with the issue of studies or with regulation but I do disagree with the tone of the article.
I am part of a long term study to see how I progress over many years.
20
@SL - I think the article is too wishy washy. It should have come down hard in exposing the financial incentive that is guiding this practice by health care providers. In my town, a general surgeon who lost privileges at a hospital, is doing this in partnership with a chiropractor and offering dinners to bring in clients. Ofcourse, because of whatever he did at the hospital, he will have a hard time finding a hospital to do general surgery so now he is doing stem cells.
I do not know what else you have done to get over your symptoms - did you lose weight? did you strengthen your muscles? did you change your activity level? What else are you doing in addition to stem cell/PRP? These are questions are relevant to be answered by every one who are crediting this unproven stuff for pain relief.
15
These stem cell transplants are at best useless and at worst dangerous. No amount of personal testimony will convicts me otherwise. Outside of a randomized, hopefully double blinded, clinical trial will make me believe. Lacking that we should accept the null hypothesis that this a expensive snake oil.
14
@Stefan I know of one drug, over a hundred years old, that was never studied using a double blinded, placebo controlled protocol and never will be. It has 100% acceptance world wide. Rabies vaccine. Prior to the vaccine developed by Pasteur the disease was 100% fatal. His patient survived. No one would suggest or consider doing a placebo controlled study to prove it's efficacy.
Certainly any new version of the vaccine requires study to check for safety but instead of a placebo it will be studied against the present version of the vaccine.
3
This article along with the two others linked below -- concerning contamination of generics and the conspiracy among generic drug manufacturers to raise prices as much as 1000% - all illustrate the need for a stronger, better funded FDA. Why did FDA decide to cave into these snakeoil salesman? Follow the money.
https://www.nytimes.com/2019/05/11/opinion/sunday/generic-drugs-safety.html
https://www.nytimes.com/2019/05/11/health/teva-price-fixing-lawsuit.html
Safeguarding the public is a non-partisan issue as Scott Gottlieb, who probably sits diametrically from me politically, sees the same problems I do.
Companies who require their workers to get evaluated or mandate stem cell injections as treatments are putting themselves at high risk for little/ no gain. If any untoward circumstances occur, they have no backing scientifically that this works and they've just mandated harm for their employees.
16
Stem Cells transplant has certainly been known to prolong life and minimize disease. Ironically, my Trumpie step mother who was so against stem cells during the Bush era didn't think twice about using stem cells n her terminal cancer son...which did make a difference.
6
Recently I've seen sporadic TV ads for stem cell treatment usually for orthopedic problems or arthritis. On another occasion a lay person was asked to speak at a multiple sclerosis meeting about the wonderful effects his son had seen with stem cell treatment after his initial episode with MS some three months prior.
In both of these illnesses the usual pattern of the disease it to wax and wane especially during the first few years. This pattern makes those who are unschooled in the nature of these illnesses easy victims of unscrupulous quacks. My initial impression is stay away.
28
I have an orthopedic doctor that I have seen for over ten years. He has helped me greatly, but the injections into my ankle with my own platelets did not work. Sometimes it works , sometimes it doesn’t. But you have to keep walking so I’ll keep trying.
2
"...[In a Clinical Trial] Patients with arthritic knees got either exercise therapy, or stem cell treatment. After three months, the patients given stem cells were doing better. But all the patients in the exercise group later got stem cells, too, so the results are hard to interpret."
Actually, this information provided in this paragraph is hard to interpret.
Deconstructing it is like taking a William V. Haney Uncritical Inference Test.
So, lets go.
(1) "After three months, the patients given stem cells were doing better."
(2) "But all the patients in the exercise group later got stem cells, too, so the results are hard to interpret."
Not provided is either a link to the study, or at least the study's title. That way we might be able to figure out:
(1) What were the results of the exercise group after three months? Better than before, but not as good as the group receiving the stem cell treatment?
(2) How long after the three month period did the exercise group start receiving the stem cell treatment?
(3) How long did the exercise group continue their exercise (if they continued it at all) after they started receiving the stem cell treatment, and how long (another 3 months?) before they were re-evaluated for the combined treatment (if there actually was a combined treatment)?
Enquiring minds want to know.
(An advertising slogan used in the '80s by the National Enquirer!)
16
@MM
Agreed. This article is filled with redundant and contradictory information and should go back to the editors.
Also, I'm seriously wondering what makes clinics offering a single procedure a reason why doctors would want to affiliate with a third party like Regenexx.
Something is missing about the equipment involved in this procedure, or what goes on in these clinics.
if it's as easy and using a few sterile syringes and an ultrasound machine, why can't a doctor be trained to perform this technique in their own offices?
9
Some people age well, some don’t. Some accept conventional treatments, others don’t. Some people are willing to buy faith-based substitutes, some aren’t. For now I live the GOP health care option: stay healthy. When the inevitable happens, I will choose mechanical options- joint replacement most likely- unless I see substantial evidence that the proposed alternative is demonstrably better.
5
My wife had stem cell replacement in her thumb. It worked fabulously. She is now scheduled to have the other thumb done next month. Her pain was unbearable. Now, she has full range and function in the operated thumb. Based on the success, she decided to have the other thumb done. Perhaps the people in this article had problems. I wish you had shown the other side/the success stories. On a related point, it’s sad that the consumer has to do so much research to find decent health care services. I know her doctor is good based on the outcome.
14
Anecdotal data does not a study make.
15
@Joe
This is not enough evidence to draw a definitive conclusion. For instance, following the "stem"cell injection, your wife may have paid "religious" attention to other conservative treatment approaches that would also alleviate pain, though only temporarily. This is precisely one of the secrets of medicine: It doesn't matter HOW we make the patient better, only that we do.
As for the stem cell treatment, show me an X-ray before and now after her basal thumb joint got better. If I can quantify it, I believe it.
As for the other hand, if you and your wife are convinced that this is what helps, by all means. But be cognizant that there is the very real risk of infection and that it may not be the stem cells doing the trick. Just don't tell your wife, because if you do, it might stop working.
6
@Joe
I hope she does not develop a tumor from the cells injected.
1
Maybe this works, but in the absence of data the conclusion is that it does not. The general assumption in medicine is that until it is proven using high-quality double blind studies, it’s utility is unknown and unproven, and should not be widely adopted. There are already many effective approaches for treating osteoarthritis, particularly in the hip and knee. These approaches have been identified and promulgated as a result of high-quality studies. The possibility of harm when patients are treated with interventions of unknown effectiveness is very high. While some patients report dramatic improvements, the power of the Placebo effect cannot be underestimated. Patients who claim that they would never exhibit a placebo response are incorrect. Virtually everyone will display a placebo response under the right conditions.
18
People ought to be able to choose which treatment is best but the Stem Cell/Platelet firms are making unproven claims and people are basing decisions on little data. Perhaps enforcing existing laws against making false claims could somewhat dampen this runaway train of an industry.
4
It seems like an upside down situation. These clinics have already collected 10s of millions of dollars for iffy stem cell injections, but these "shots" still aren't proven to work & only years from now might the data be there to make a judgment.
I've been covering the 100s of unproven stem cell clinics for years as a stem cell researcher on my site The Niche. Their "research" most often has no control subjects, isn't blinded, & consists only of paying customers with the clinic owners doing the data analysis. What could go wrong? A lot. It's encouraging that the FDA is at least doing relatively more now and the NY AG just sued a clinic in Manhattan, but far more action needs to happen quickly.
100
@Paul Knoepfler
Amen. Point your readers to the NEJM article on stem cells and its second to last paragraph.
10
@Paul Knoepfler Dr. Knoepfler, I want to personally thank you for for your work educating the public about stem cell tranplants. As a doc, I have had patients ask me about them and my quick look indicated it was mostly snake oil. I referred them to your site for information written in lay language about stem cell clinics.
(I wrote my message a while ago and linked to the lay person summary but it appear NY Times did not print my message. Not sure why not as it is directly relevant to the article, is sourced from someone they interviewed, and would be useful for the public.)
10
The key issue is how much will patients receiving new, unproven stem cell treatments be definable as human experimental subject i.e., guinea pigs with data coming from settings where it is often about profits? There is both and ethical and scientific issues in play here. I think what we need to address is whether highly unproven and minimally tested therapies can be adequately described to the patient or should more data by FDA approved and reviewed clinical trials be required?
New biological therapies represent a new field with little long or intermediate term safety and efficacy data.
9
Stem cells may not help the patients but they sure help the quacks bring in good income. People are giving good money to make a fool of themselves. I think people are getting their money too easily...
No one is asking for science behind changing stem cells into cartilage. What is the needed signal? Where does it come from? How effective is it? How long will it take for that signal to work. For sure it is more than just a few hours.
Then there is science of separating stem cells from everything else in the blood.
If you stand on a joint full of stem cells, those are really pushed out of the joint because bones are pushed together due to gravity.
In a simplistic model - (i) joint surfaces need to be kept separated by an external frame until stem cells are changed into cartilage and are firmly adherent into the underlying bone, (ii) stem cells have to be combined with appropriate signalling molecule in appropriate amount for injection, (iii) something needs to be done to the firm cortical bone at the joint surface so these stem cells can hook into this bone as cartilage.
Blood is highly inflammatory substance and repeated injection of blood in the joint causes arthritis as in hemophiliacs. Stem cells needs to be separated from components of blood that cause inflammation.
Unfortunately hope for quick cure is overwhelming lots of good questions that need to be asked before handing over 7000 dollars or so to the quack..
33
@sk Inflammation is not always a bad thing. It is, in fact, part of the healing process.
So I wonder whether some of the positive results these clinics report might be more attributable to inflammation than to the stem cells or PRP itself.
5
@Justin - Inflammation is part of healing process after surgery and that is probably only time that it is a good thing. Inflammation from injection of blood components destroys cartilage in the joints and causes arthritis. It is not a good thing.
5
@sk
sk, isn’t Justin saying that inflammation supplies the very “appropriate signalling molecule” you refer to?
2
People think there is a conspiracy to not help you and that unapproved treatments should be used. The real problem is there should be strict regulation of stem cell and other blood cocktails.
I get an invitation for a free dinner and presentation by a doctor who makes wild claims and wants to inject stem cells. That is a pretty good sign that the 'snake oil' salesmen are out with carnival barkers to get you in.
The FDA should put a quick stop to this hucksterism. The FDA should regulate stem cell and blood platelet use. We need real science not videos and unsubstantiated claims. As our population get older there is high interest in knee, hip and lower back treatment. Older people are desperate and will try mosty anything. The role of government is to step in and regulate.
50
@Harry Schaffner
"Free" dinners are a sure tip-off that some sort of rip-off is in the making. Makes you stop and think - if the products are so "great" (think BigPharma ads, and those one-pagers in the newspapers), why are all those ads so necessary?
15
@Harry Schaffner
Like the warning labels on cigarettes, the FDA should, in a brief statement, spell out the facts, and this statement should be signed by every “stem cell” patient.
6
I am bone on bone in both knees. My ortho has been telling me since I was in my early 40s (I'm 57), I need to have them both replaced. My diagnosis is "severe osteoarthritis". In the last 3 years, I've lost 150 pounds, started working with a trainer, become more active and my pain has decreased.
I still occasionally do the mambo of cortisone and viscous supplementation, but I also fence at a national level and compete nearly every weekend.
Recently, I started to see an osteopathic manipulative medicine doc who also does acupuncture. After 2 visits, my knees have never felt better with no real risk of infection, having to wear a brace for weeks or having some sort of pseudo-science injected into my knee.
I'm trying to hold out til 65 or 70. I think I can do that now. People need to realize that there is no overnight cure for lack of activity or years of overuse and improper care of one's body.
50
Congrats on your weight loss. That is a therapy which will work for many of these issues.
27
@knitter215
With any treatment a lot of people feel better. That is called the placebo effect.
8
@knitter215
Keep the faith! I'm 77, knees "bone on bone", and use a cane now and then. Tai chi seems to help, walking helps, good shoes and boots help, and accupuncture's coming up next!
15