Patients guide to stem cell treatments for 2021

For better or worse, I am in the unique position of being a stem cell scientist and also a former cancer patient. Looking on the bright side this gives me a unique perspective on things compared to many of my colleagues.

I know there are thousands of people out there looking for more practical information about stem cell therapies and treatments. These folks understandably are using the Internet to look for some clear, good info on stem cell treatments either for themselves or their loved ones. Too often the info that is out there is either wrong, partially misleading, biased, or overly complex.

neural stem cells, stem cell therapy
Differentiating neural stem cells.

So in this post I want to address this need for trustworthy factual information and no-nonsense perspectives. I am speaking as a scientist, patient advocate and cancer survivor in the form of 10 key realties list below to help you guide your way through the jungle of stuff out there about stem cells. As mentioned above, I have now updated this post for 2021 as some things have changed in big ways in just the past few years.

Keep in mind this is not medical advice and you should absolutely talk to your personal doctor with whom you should make your own decisions.

Stem cells are often essentially a type of drug and possibly permanent in your body after a transplant.

Yes, stem cells can be extremely unusual drugs, but they are often drugs even if some argue they aren’t. The FDA considers them drugs in many cases. In other cases, such as the use of bone marrow stem cells used for orthopedic conditions, stem cells may not be drugs. Unlike other drugs, once a patient receives a stem cell drug, it will not necessarily simply go away like other drugs because a stem cell drug consists of living cells that often behave in unpredictable ways. What this means is if the stem cells are doing bad things your doctor has no way to stop it. You have no way to stop it. Also because stem cells are alive they can grow inside your body, move around, and change. This can be helpful or harmful, but the big point is that it is not something that is controllable or reversible.

Side effects.

Like any medical product, even aspirin, stem cells treatments will have side effects. Not maybe. Definitely. Our hope is the side effects will be relatively mild and so mild that you don’t even notice. Different kinds of stem cells have variable risk profiles, but if someone tells you that the stem cell treatment they are selling has no risks then that is a big red flag and I would walk away. They are either woefully lacking in knowledge or aren’t being honest with you. Sometimes clinics will either on their websites or in person acknowledge risks almost as sort of a disclaimer, but then they’ll tell more casually that there aren’t really any risks. A common statement is “The only risk is that it won’t work.” That’s false.

The only stem cell treatment explicitly approved by the FDA for use in the U.S. consists of versions of bone marrow/hematopoietic stem cell transplantation.

What this means is that any other stem cell treatment you see advertised on Facebook or Google or elsewhere that indicates it will be given to you inside the U.S. is not FDA approved. The exceptions to this are if it is part of an FDA-approved clinical trial or it is using stem cells in a procedure that meets other criteria (e.g. being both homologous use and minimally manipulated–yeah I know these are jargon terms).

If you venture outside the U.S. for a stem cell treatment, use extra caution, but in 2021 also be very careful inside the U.S.

Whether you travel abroad or closer to home, have a knowledgeable physician inside the U.S. guiding you, preferably your primary care doctor who mot often are not going to buy into hype. We have to avoid the trap of thinking that only the U.S. can offer advanced medical treatments and these days many American patients get their stem cell transplants here in the U.S. from dubious clinics.

Stem cells are not a cure-all.

I am as excited as anybody about the potential of stem cells to treat a whole bunch of diseases and injuries, but they are not some kind of miracle cure for everything. When a doctor offers to inject some kind of stem cells into a patient either into the bloodstream or into a specific place that is injured such as a shoulder, we just do not know at this point if it will do any good with the exception of bone marrow transplant. You should start getting worried if the clinic tells you that one kind of stem cell such as fat, bone marrow, or amniotic stem cells can treat many different conditions. There’s no science behind that kind of claim. Stem cells are not a panacea.

Patients often mention to me that the doctors offering stem cell treatments told them that the treatments are proven safe….or that your own stem cells cannot harm you…or that adult stem cells are harmless. I often tell people to think about how much research and how many questions they ask when looking to get a new car. You should bring at least that level of intensity (ideally much more) to getting info about stem cell transplants too as the stakes are even higher. Be skeptical. Ask many questions and if you aren’t convinced, then don’t do it.

Don’t let celebrities be your guide to medical care.

The number of famous people getting stem cell treatments is increasing including sports stars and politicians. Don’t let what these folks do influence what you decide to do about your health. Just because they are famous do not believe for one minute that they are any more informed than you or your personal doctor about medical treatments or stem cells. If anything I think sometimes famous people are more reckless with their health than average people like you and me.

Reach out to scientists as a source of info.

As a scientist I am always happy to hear from people outside the scientific community with questions about stem cells and other research. I can’t speak for all stem cell scientists but you might be surprised at how likely it is that if you send them a very short, clear email with one or two questions that they will respond and be helpful. We can’t or shouldn’t offer medical advice, but we can give our perspectives on stem cell research and its clinical potential, etc. Just do not cold call scientists as you are unlikely to find them that way and even if you do, they may be cranky. Email. If they don’t reply try someone else and don’t be offended they we didn’t answer. Often times we may not answer because we are super busy. For instance, I often get more than 100 emails a day.

The people selling you non-FDA approved stem cell treatments want your money.

As such they will do their best to convince you that their treatment is safe and effective. The more convincing they are then the more money they make. They may offer patient testimonials either from patients who truly believe they were helped or from people who are paid to say the treatment helped them. The bottom line is that the sellers of dubious stem cell treatments are generally in it for the big bucks. Admittedly I do think that some of these providers truly believe stem cells are helpful, but you’ll never see even them offering to give patients the cells at cost. These are instead very much for-profit operations.

Just because something is called a stem cell “clinical trial” doesn’t mean it really is and being listed on means a lot less than it used to.

I am contacted weekly or even daily at times by patients or their families and they are rightly focused on getting information that they can trust. Many stem cell clinics call the treatments that they offer by the name “clinical trial” and that’s often misleading. In the standard meaning of “clinical trial” the experimental therapy being tested has the FDA’s approval to be used in the study, there are data supporting the study, and those doing the trial do not charge patients to be in it. You shouldn’t have to pay to be a guinea pig. I think that’s almost always going to be unethical on the part of those giving it. I often suggest that people turn to the federal website for information and that is still a great resource, but be aware that many pseudo-clinical trials are popping up on there that are really mostly about making money. They do not have FDA approval in many cases and there are other issues of concern. So even on that website use caution.

The most important thing is information/data and you have a right to see it before treatment.

Before you or a loved one get a stem cell treatment, ask two key questions. First, is the treatment FDA approved and if not, why not? Second, can you please show me the data that proves your treatment is safe and effective? See what kind of answer you get. If they demonize the FDA or invoke a plot by “big pharma” to block stem cells then that is a warning flag. If they refuse to show you data, then that is a big red warning flag. They may say it is confidential or that it is not published yet, but as a patient you have a right to see the data, assuming they have any data at all.

These facts will likely change over the coming years, but right now I think they represent reality. I know as patients we need hope, but these unapproved stem cell treatments will at best take your money for nothing, and at worst will endanger you or your loved ones.

The post above is for information only and is not medical advice. All medical decisions should be made by patients in consultation with their personal physicians. The content on The Niche is informed by our Medical Advisory Board.

26 thoughts on “Patients guide to stem cell treatments for 2021”

  1. The Mayo Clinic has just published its report of the first ever randomized, blind, etc. test on set cell injections
    in the knee. go there to see what a great success it appears to be. I am sure that it is difficult to get admitted into their clinical trials, they need only certain kinds patients for their tests.
    However, this randomized, formal test at the Mayo in Tallahassee was last completed three years ago, and the patient treated is still doing very well (according to Mayo’s notes).

    I am quite distressed at the cost at private clinics. I understand that it is a herculean effort to get FDA to agree that something is good. It is the nature of our “lobbying” system. I intend to try this therapy on my shoulder, (which has no rotator cuff left), but I am having difficulty finding the least expensive but trustworthy place.
    I also agree that practicing doctors (internists, or others, including PHD’s) are going to say that this is not tested, and safeties still 10 years away. but, I was able to convince my internist that she is wrong. It seems to me that the prices should come down, now that Mayo has opened the door.
    I have a life long friend who was trying to treat Autism and other disorders with stem cell injections, some 20 years ago when it was illegal in the U.S. the parents usually would fly their kids or whomever to Bahamas or somewhere within restrictions, and a doctor from Europe would fly over and meet with these American families, giving them whatever stem cell treatment seemed to work.
    My friend had a child with infantile MS. and although the stem cells did not cure the disease, it obviously made the patient better right away. He was able to move his limbs, be active, and had no pain. Now, 20 years later, we are moving ahead quickly. I have not found, in all of my study, any bad side effects from stem cell therapy, except for the two ladies in Miami. They apparently tried to treat glaucoma or macular degeneration with stem cell therapy, and the procedure left them blind. Details will not be available for a long time, I am sure. But, in just the last few years there have been thousands of people paying to have stem cell therapy done. If this particular case of failure is the only one out there, I’d say the odds are pretty good for both safety and results.

    I intend to give it a try; I am convinced that it is safe, (so is my doctor), just being used as a greedy money making scheme by the doctors or medical assistants who are involved. Their profit is 200 to 300 percent of the actual cost.
    But, then look at the dentists in this country. there is no “medicare rule”, that toned down their salaries, and they have a very strong union to be sure that doesn’t happen. In the meantime, with a very small investment, in terms of years of schooling (maybe 2 or 3, in college), and they are practicing and charging $3000 or more for a single crown and/or root canal.
    the inequities of life!
    If anyone finds a cheaper place to have the stem cell therapy, please pass it on. thanks.

  2. I am looking for the best stem cell clinic in US.I have heard about combination of adipose tissue ; your blood for growth factors and umbilical tissue.Has anyone heard of a clinic in Miami? Thanks.

  3. I just read this: “There are different types of stem cells, each with their own purpose. It is unlikely that a single cell type could be used to treat a multitude of unrelated diseases that involve different tissues or organs. Be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated. … Be wary of clinics that measure or advertise their results primarily through patient testimonials, which may by unrelated to the actual stem cell treatment, arising from the “placebo effect,” accompanying treatments, and natural fluctuations of the disease or condition” (CBS news).

    I have a torn meniscus and a ruptured ACL. The surgeon suggests repair surgery, but warns 9 – 12 months recovery time. I found stem cell injections as an alternative which claims 4 – 6 weeks recovery. The company that I am looking into uses stem cells from bone marrow in the hip, counts them out, and puts them directly into the injured parts of the knee. (They brought it to the US in 2005) I have found no negative results, only a significant number of patient testimonials. Is this procedure safe, effective, and truly a one time treatment? How would I know that the doctor has the proper/best qualifications? It is so confusing. Please help.

  4. I would very much like an explanation of how stem cells are a drug but an organ transplant, a blood transfusion or a bone marrow transplant (which is suddenly being called “stem cell therapy”) are not drugs.

  5. I really appreciate your comment about how the most important thing when considering a stem cell treatment is information and data proving that it is safe and efficient. Whether the treatment is for you or your pet, I feel sure that this reassuring data would be good to have. Any quality care provider would probably be happy to give it to you as well.

  6. I’m desperately trying to find out who in this country are considered the very best in the area of stem cell treatment for arthritis in the hip. I sent Dr. K an email and am hoping to hear back.
    I’m just now researching this and the information out there is absolutely overwhelming. I’m sure some reading this post have done extensive research into this already. I would so appreciate any help in this — I want to help my wife who has had a hip resurfacing a year ago. The other hip needs attention and I’m hoping I can help her avoid another surgery and recovery. I sent the film to the Mao in Jacksonville and the physician said she wasn’t a candidate. She is in otherwise excellent health, 59, and ideal height and weight. She eats right. I’m hoping to find the few “very best” to see if they’re able to help.
    Please let me know.
    Bob Keen

    1. Bob– I am basically in the same situation you are—you are further along in your research, since I am just starting — if and when you find what you feel is the best clinic for stem cell treatment, please let me know and I will do the same for you.

  7. Once the FDA approves a stem cell procedure to treat osteoarthritis and that procedure becomes reimbursed by the insurance industry, these clinics will either adopt the approved procedure or run out of patients willing to pay 100% of the amount charged. As a capitalist invested in Cytori Therapeutics, I am counting on the FDA continuing to label ADRCs as drugs with a biologic approval pathway or a medical device pathway. The Celution system isolates ADRCs at the bedside and produces a clinical grade dose that has been approved based on safety demonstration in every country except the USA. Japan just approved its use for knee injection on June 24th. Four years ago, the EU approved injecting ADRCs made using the Celution system into the IV system. Although the FDA has granted IDE for injection into the knee (ACT-OA) and the heart muscle directly (ATHENA) and the fingers of scleroderma patients (STAR). Results from the 84 patient ACT-OA trial are expected to be released in August. Lead investigator, Dr. Brian Cole, at Rush in Chicago (among others) adds a lot of credibility to this stem cell trial.

    Basically, the FDA wants to approve a stem cell procedure as long as that procedure follows the rules set by the almighty FDA. I know for a fact big pharma has lobbied the FDA to take this course of action and, of course, the FDA has complied.

    1. @Lewis,
      Any thoughts on when the FDA might approve a stem cell product/procedure for arthritis or other ortho applications?
      I’m glad that you mentioned Cytori and the cases of IDE, as they are very relevant here.
      That long-standing notion of the FDA being controlled or at least strongly influenced by big pharma–do you have any concrete evidence of that?
      Thanks for the comment. Paul

      1. I cannot produce the evidence at this time, but I know where to find it. I believe it was the year 2011 when Cytori sued the FDA for its rejection of their 510K application for the Celution 800 system. During the discovery period, Cytori’s attorney (Mitchell Feurst) came upon a letter written by a large pharmaceutical company to the FDA (I seem to remember it being Cephalon, but I am not sure. I do remember this pharmaceutical company was bought out in that same year). The letter was read to me over the telephone. The message was that approval of autologous stem cell procedures would be unfair to the pharmaceutical industry because it takes 10 years or so and a lot of money to gain a drug’s approval. The letter urged the FDA to force stem cell procedures down the same approval process as drugs. I consider this to be a lobbying effort by the pharmaceutical industry rather than an illegal restraint of trade action. We all know lobbying works!

        As far as I know, Cytori is farther along the path than any other stem cell company. The last patient out of 84 had their 48 week MRI about one month ago. The CRO should hand over the data to Cytori in the coming weeks. Based on the results, the company will decide where to go from here. A partner will be necessary to continue with a pivotal phase III trial with 400 patients. That would take a year plus another year for follow-up and another for FDA admin type work. So, my best guess is at least three years for USA approval. By that time thousands of legally approved procedures will have occurred in other countries. There will be plenty of fresh data to add to what is already out there (and there is a lot of it). There has never been a safety issue with clinical grade ADRCs or BM. The safety concern is about the isolation technique and purity of the cells injected into the patient. Injecting matter into the blood stream that contains dead cells and debris is not a good thing in my book.

        In my opinion, the FDA is guilty as hell for not approving the Celution system (and a few other high quality cell isolation systems). It was because these clinical grade ADRCs actually work as intended that the FDA is requiring the trials. If the cells are not minimally manipulated, the FDA says “go ahead and inject a bunch of junk into humans, we only regulate stuff that works.” I think I am most frustrated because Wall Street has been kept away from investing in stem cell research. It boggles my mind when I think of how easy it is to raise billions to start some worthless social media company, but there is no money supporting the regenerative medicine field. This is a new field of medicine that will save billions of tax payers dollars and achieve amazing results without nasty side effects.

        Phase II data has been very slow to come, but it won’t be long now. I hope the research dollars become available soon to speed the development of this new field of medicine. To support phil s, there are true pioneers out there who blaze the trail for others and there are the 60 Minutes types who taint the industry. The FDA could do a lot more for our health care system, in my opinion.

  8. Phil Sakalewski

    (Sigh) so dr knoepfler would have us believe that only he knows best when it comes to anything related to stem cells and their clinical applications.

    Columbia medical school, the Mayo clinic, Regenexx and Emory – they’re ALL sheisters right?

    1. Thanks for the links. Interesting reading, but I don’t see anything that contradicts D. Knoepfler’s comments. Can you cite the comments you think are wrong?

      1. Knoefler is a researcher, not a clinician. I am happy for him that he is a cancer survivor. However, this does not make him an expert across the wide range of clinics that he has lumped together in his recent publication (he went online and googled stem cell clinics on the internet, but did not examine the evidence for what most of those clinics actually do.)

        Dina Maron’s article in scientific american is tabloid-style and Knoepfler’s article is self aggrandizing and misleading to the public: both would have you believe that the research and clinical work at orthopedic clinics and academic medical centers (yes, there exist other legitimate institutions doing solid work other than Dr. Knoepfler’s ivory tower at UC Davis) is completely bogus.

        Unfortunate that Maron’s reporting results in legitimate clinics (board certified medical doctors : orthopedic surgeons and physiatrists who specialize in the field of musculoskeletal/cartilage/tendon/bone injuries recovery/rehabilitation/repair) being lumped in with sketchy, poorly credentialed practitioners at a minority of clinics who are treating conditions unrelated to their proclaimed medical specialty (i.e., why would any physician but a neurologist or neurosurgeon be attempting to treat alzheimer’s or autism with any kind of treatment at all?)

        There is more than enough scientific literature to support the use of MSC via bone marrow or adipose for orthopedic conditions.

        That’s why forward thinking orthopedic surgeons and physiatrists (physicians board certified in physical medicine and rehabilitation) are using biologic treatments.

        Does more research need to be done? Yes. Do long term outcome studies need to be done? Yes. Do we need to examine the safety and efficacy? Yes.

        But, umm that’s what is constantly needing to be done in all fields of medicine: examine, test, see if we can reproduce data, test it again.

        What Knoepfler fails to realize (because he is not a clinician) is that good physicians continue to do that all the time.

        Note the boilerplate text that knoepfler does put in at the end: “consultation with their personal physicians.”

        (by the way, anyone who doesn’t recognize the FDA’s shortcomings, and doesn’t acknowledge “big pharma’s” influence on our economy and overall healthcare is either ignorant or employed by said company.

        Yeah, I know, its knoepflers’ blog. So I get it. He just wants his 10 minutes of fame. Guess he got it.

        1. @Phil, I appreciate your comment even if we don’t see eye to eye.
          Maybe you could tell us more about your own experiences. You don’t even have to identify yourself specifically.
          Are you a care provider giving patients stem cells? If so, what’s your experience been like and what kind of cells do you use and for what conditions?
          How can this area be regulated better to take into account the more concerning operations you mentioned, while also factoring in what you see as more legitimate uses?

          1. No, but I am a healthcare provider. I’ve been closely monitoring the studies regarding BMA and ASCs for orthopedic issues, but I haven’t utilized it in my own clinic yet.

            The article in Sci Am is a tabloid style vilification of legitimate clinicians/orthopedic surgeons and physiatrists – by casting them in the same light as, for example, a plastic surgeon or naturopath who has no business even pretending to have expertise in treating a neurologic disease, advertising treatments for spinal cord injury.

            Just as that plastic surgeon is doing harm to the field of regenerative medicine, so is disregarding the hard work being put in by clinicians at academic medical centers across the country.

            Disappointing that Dina’s sloppy journalism was featured in such a well regarded publication for the lay person. I guess it wasn’t important enough for dina to interview the clinicians at stanford, mayo clinic, or emory (just to name a few of the many) before going to press.

            Studies have been published that clearly demonstrate a reasonable degree of safety for utilizing these techniques in legitimate orthopedic and rehabilitation clinics.(if you or dina would actually take the time to look at the clinical literature, perhaps her article would have been crafted differently.)

            FDA is a government agency that has a responsibility to regulate drugs and certain devices. Ok. I get that.

            But are you really saying that anyone who acknowledges the influence of big pharma on our government is paranoid or a charlatan?


            Why don’t you attend one of the orthobiologic (TOBI or AAPMR) conferences and discuss your concerns directly with the clinicians who are on the front lines, treating patients every day? Would make for a great panel discussion.

                1. Trish, did Stef respond with the type of treatment that she had at Regenexx that she said was successful?

        2. Well, that’s a long excursion, but you still didn’t answer the question, “Can you cite the comments you think are wrong?” So I guess you’re also seeking 10 minutes of fame. Guess you got it. 😉

          1. 1. “…often…essentially…possibly…”

            Hedge, hedge, hedge – then he makes a sweeping generalization to demonize all 570 clinics.

            Contrary to what he would have you believe, legitimate regenerative & orthopedic clinics are using autologous cells and not lyophilized (dead, frozen cells) amniotic tissue so no, they’re not drugs – they are your own cells.

            On the other hand, IF clinics are using expanded cell lines (ie, culturing/growing/adding enzymes to your cells before putting them back into your body) then technically, according to the FDA, they are no longer your cells, but a drug.

            And yes, clinics such as these should not be operating in the US, per FDA regulations.

            2. Let’s clarify. Side effects are more likely to be from the physical procedure of obtaining/delivering/injecting the stem cells to their intended target. (i.e. there are plenty of physicians that still inject things like corticosteroids blindly (ie, without ultrasound guidance or fluoroscopy/xray guidance.) If your physician is injecting anything into your shoulder/hip/knee/spine and without visual guidance, you should ask why. (Except for things, for example, like flu shots and vaccinations, where a systemic effect, and not just a local effect is desired.)

            Any medical procedure has “variable risk profiles” but legitimate clinics will check for relative contraindications such as active autoimmune conditions, malignancy/leukemia/lymphoma, etc.

            In Knoepfler’s view, we should not be donating blood, platelets, corneas, skin grafts, bone marrow, cord blood, spermatozoa – oh wait a minute. Those are ALLOGENEIC (ie, from another person altogether.) Sorry, I almost forgot that his article is an attempt to vilify and panic everyone about using AUTOLOGOUS (your own) cells. I don’t know about Dr. K, but I recommend my patients bank their own/autologous cells, rather than risk a transfusion from an anonymous random person via the blood bank.

            “A common statement is “The only risk is that it won’t work.””

            False again. Legitimate clinicians (physician working with patients on a regular basis – which Dr. K is not, so he is unfamiliar with the importance of informed consent) will carefully review the potential risks, benefits and alternatives for treatment before proceeding with any medical procedure (not just bone marrow aspirate or fat aspirate for musculoskeletal conditions, but for any medical procedure, no matter how seemingly mundane or commonplace, such as influenza vaccine, blood donation or receiving a blood transfusion.)

            Perhaps Dr. K is basing paragraph 2 on his personal experiences, which would be unfortunate. Any medical doctor that limits their review of potential risks, benefits and alternative treatments to saying” “the only risk is that it won’t work” is one I would avoid as well.

            Paragraph 2: great job with the fear mongering, Dr. K.

            3. (sigh) He’s fear mongering again. “…explicitly approved by the FDA…”

            The FDA has moved its February 2016 hearing to September 2016 to review testimony from clinicians, researchers, attorneys and YES – you can be sure that the pharmaceutical industry will have a presence as well.

            (Please note that Dr. K’s perspective is that of a researcher in a laboratory, with no practical knowledge of direct patient care on a daily basis. Yeah. Dr. K professes to use a lot of jargon. That doesn’t make him an FDA attorney or an MD with clinical experience.)

            Instead of taking Dr. K’s myopic opinion as the word of God, let’s see how it plays out at September’s hearing and let the FDA rule on this.

            4. “If you venture outside the US…use extra caution…but in 2016 also be careful inside the US…”

            Dr. K would have you believe that ONLY PhD’s should be giving the “all clear” on what is safe for using stem cells in the practice of medicine. While I agree that basic research is important, clinical decision making should be left to medical doctors.

            One should be leary for example, of any physician treating conditions outside of their sphere of expertise (ie, why in the world is a plastic surgeon injecting stem cells via IV to treat a neurologic disease.)

            Patients should know that there are plenty of board certified orthopedic surgeons and physiatrists from academic medical institutions (Mayo clinic, Emory, Stanford, Cornell, Columbia – this is by no means an all inclusive list) who are providing advanced regenerative techniques for musculoskeletal & orthopedic conditions and that these academic institutions themselves (again, the above mentioned are by no means a complete list) are amongst many clinics from which one can expect good medical care as well.

            5. “Stem cells are a cure all.”

            No responsible physician – regardless of specialty- would make such a sweeping comment. Guess what Dr. K is quietly trying to do again?

            His recent publication vilifies all 570 clinics that he googled. Whew! Gosh. That must have taken a long time to do all that googling. What an accomplishment! But lazy work, nonetheless. So he documented 570 clinics that utilize stem cells in some way. BFD.

            Instead of differentiating what any of those clinics do, he simply lambasts them all.

            Are there sketchy ones out there? Yes. Are there bogus doctors out there? Yes. Are the majority of them plastic surgeons treating multiple sclerosis/autism with IV stem cells, or blindly injecting rotator cuff tears with an adipose graft. NO.

            Doesn’t matter if you are seeing a physiatrist for help with your rotator cuff or knee arthritis, an endocrinologist for your diabetes, or a cardiologist for atrial fibrillation. It’s important to see the appropriate specialist and to ask reasonable questions.

            Getting clinical advice from a PhD with no clinical experience is inappropriate.

            6. “Don’t let celebrities be your guide to medical care.”

            I’d bet a box of twinkies (or if Dr. K would prefer, devil dogs?) elite athletes are more careful with what they put in their bodies than Dr. K or most folks for that matter. Steph Curry, Maria Sharpova are amongst many that have utilized regenerative orthobiologics.

            Dr. K is grandstanding again. We can’t categorize the motives of Mr. Curry or Ms. Sharpova for undergoing treatments as being the same as those of Dr. Oz or movie actor “xyz” peddling vitamins on TV.

            7. “…We (PhD’s) can’t or shouldn’t offer medical advice.”

            Couldn’t agree more on this one. So why is he doing it?

            8. “The people selling you non-FDA approved stem cell treatments want your money.”

            We already discussed the “non-FDA approved stem cell treatment” issue above.

            However, there is more than sufficient research to support safe and reasonable orthobiologics (platelets, bone marrow aspirate, adipose graft) treatment of orthopedic and musculoskeletal conditions. Too numerous to list. However, Sampson, Bemden, and Aufiero’s article Stem Cell Therapies for Treatment of Cartilage and Bone Disorders: Osteoarthritis, Avascular Necrosis, and Non-union Fractures published in the AAPMR journal in 2015 is a good place to start.

            Do we need more research and clinical information? Definitely.

            Do we need to stop the bogus clinics? Definitely.

            Are ALL of the clinics noted in Dr. K’s publication bogus? Nope. No. Definitely not. Dr. K and the recent article in scientific American just want everyone to believe they should all be shut down.

            By the way. Guess who wants your money and has billion$ riding on September’s hearing? Guess who will not be making as many billion$ if orthobiologic treatments make painkillers and orthopedic surgical implants unnecessary?

            Rest assured that pharmaceutical companies will have a strong voice at the hearing in September. Anyone who doesn’t agree that lobbyists for those companies have a huge amount of influence in Washington is naive (or is on pharma’s payroll*.)

            9. “Pseudo-clinical trials are popping up there that are really mostly about making money.”

            Don’t be mislead by sweeping generalizations. Keep in mind that the entire FDA regulatory process is all about making money.

            10. “If they demonize the FDA or invoke a plot by “big pharma” … then that is a warning flag.”

            Please substitute FDA and “big pharma” with: any large governing body/institution that has been investigated recently. Think ‘catholic churh, police department, notre dame administration, subprime mortgage lenders, investment banks that created CDOs’ – given recent current events, why would any rational person NOT ask those questions?

            Please see item 8 above.

            *Would be no surprise to learn that he is on the Pharma payroll.

            Not enough to make him fabulously rich but just enough to make him their lackey. Little enough to make him envious of legitimate clinicians making a living by working hard and helping patients.

            1. An interesting critique, but you are doing exactly what you accuse Dr. Knoepfler of, i.e. making sweeping statements without factual support. The difference is that over many articles, Dr. Knoepfler has provided source material and peer-reviewed references, whereas you have not. But maybe you also have a blog with some supportive evidence for your statements? Please post a link if so.

  9. company called regenerex, with fancy research and promises. very active many doctors involved. claim they do their own research.


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