AVMA Policy Cautions Vets about Unproven Stem Cell Therapies

The American Veterinary Medical Association (AVMA) is the main professional organization for veterinarians in the United States. It is not a government or regulatory body, but it does sometimes promote policy statements or guidelines intended to encourage or discourage certain practices by veterinarians. In general, I have been disappointed in the unwillingness of the AVMA to confront the danger pseudoscience presents for veterinary patients, clients, and the integrity of our profession.

For example, despite the clear statement of its own Council on Research acknowledging that, “there is no clinical evidence to support the use of homeopathic remedies for treatment or prevention of diseases in domestic animals” the AVMA House of Delegates overwhelmingly rejected a resolution identifying homeopathy as an ineffective therapeutic intervention. This was a pure case of politics trumping science and of a political organization refusing to protect the public from quackery because doing so would discomfit part of its constituency.

Similarly, the AVMA House of Delegates admitted the American Holistic Veterinary Medicine Association (AHVMA), the most prominent advocacy organization for pseudoscientific medical practices, as a constituent organization in 2013. This was based solely on such criteria as having enough AHVMA members who were also AVMA members, and the move ignored the blatant promotion of pseudoscience and untested or clearly ineffective treatments that is the main reason for the AHVMA’s existence.

Given that the AVMA has not been very strong or consistent in promoting science-based standards for veterinary medicine, I was pleasantly surprised by the recent AVMA position statement on stem cell therapies. I have written about stem cell therapies frequently. It is a promising area of research that, unfortunately, has been promoted and put into widespread use far ahead of appropriate scientific evidence establishing safety and efficacy for particular methods and indications.

The FDA has essentially chosen not to exercise its regulatory authority over veterinary stem cell therapies so long as they involve cells taken from and given back to the same individual and are not used in food animals. As a result, many stem cell products are legally available that have never been properly tested to show they do more good than harm. I am quite optimistic about the potential for stem-cell-based therapies to provide useful therapeutic tools eventually, once appropriate research is done, but for now they are essentially an uncontrolled experiment on individual patients.

The AVMA, uncharacteristically, appears to largely agree with this position:

While regenerative medicine holds promise of improvements in the treatment of a variety of diseases, many of which lack adequately effective treatments, questions remain…While data continue to accumulate suggesting therapeutic benefit from regenerative medicine, published peer-reviewed studies definitively documenting benefit are still lacking for many diseases. Nor has a scientific consensus for stem cell type, stem cell origin, dosage, transfer media, or method of administration been developed for each disease being treated. Despite these scientific insufficiencies, the adoption of regenerative medicine in the veterinary profession has grown rapidly. Unfortunately, some therapies being propounded and the processes and equipment being sold have outpaced the science which supports them.

Of course, like any fundamentally political organization, the AVMA has to try to please everyone, even when that results in an internally inconsistent position. For example, the policy is quite clear about the importance of validating stem cell therapies with proper research evidence before utilizing them:

Regenerative therapy protocols should be formulated from evidence-based medicine. Veterinarians should refrain from recommending regenerative medicine protocols for which documented benefit has not been shown by clinical trials.

Regenerative therapies should utilize systems, equipment, and processes which have been adequately validated to produce therapeutic cell numbers, documented cell types, adequate cell viability, and sterility. The use of systems without such validation poses unnecessary risk to the patient, compromises treatment successes, impedes collection of therapeutic data, and exposes the attending veterinarian to potential liability.

Veterinarians engaged in the use of regenerative medicine and vendors of cell products, equipment, laboratory services, and processes should refrain from making claims in client communication, advertising, or websites that are not fully supported by peer-reviewed, published data.

Since no extant stem cell therapy can meet these criteria, effectively this should mean using stem cell treatments only as part of a clinical trial research or, perhaps, as a last-ditch treatment in desperate circumstances with full disclosure to clients that the treatment is untested and experimental. That, of course, is not at all how stem cell companies and veterinarians typically present these treatments. And the AVMA weakens its own policy by not being willing to directly discourage the use of such treatments by veterinarians. Throughout the policy it is assumed that veterinarians will continue to use these treatments despite the absence of the kind of evidence the AVMA suggests should be a prerequisite for their use:

The AVMA supports the continued scientific development of these modalities while at the same time encouraging its members to employ caution with respect to their use.

…it is incumbent upon veterinarians engaged in regenerative therapies to be well versed in the emerging science of the field in order to successfully select the specific therapeutic protocols, processes, equipment, and vendors most likely to result in clinical benefit for their patients.

Despite this equivocation, however, it is encouraging to see the AVMA clearly acknowledge that the evidence base is not yet sufficient to justify claims of safety and efficacy for veterinary stem cell therapies and that their use is not supported by adequate, appropriate science. Hopefully, this will lend some weight to the voices of caution in the profession trying to restrain the proliferation of stem cell therapies until we have sufficient reason to believe they are helpful and not harmful.

 

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18 Responses to AVMA Policy Cautions Vets about Unproven Stem Cell Therapies

  1. art malernee dvm says:

    I had a patient in this morning. The dog had lost weight. The owner said it was stem cell capsules made from horse stem cells that were responsible for the weight loss. The owner then complained to me that the stem cells some doctor had been selling her were very expensive but well worth the cost because the dog needed to loose weight. My guess is these were “homeopathic” stem cells because if they were real stem cells from horses given to the dog the FDA might object.

  2. Mudasir Bashir Gugjoo says:

    For any new drug or medicine, it should undoubtly be tested to bear sufficient and clear evidence before actually being utilisd as therapeutic….However, this hardly seems to be the case with Stem cell therapeutics….In addition, the doctors whether Medicos or Vets doesn’t seem to consider Stem cell Applications as research rather therapy. Thus, it is imperative to put regulations as well as the statutories for their utilisation.

  3. I think the veterinary community is behind the human medical community in this field. Ditto for medical marijuana. Autologous type 2 stem cell therapies have proven safe and effective in human medicine and their use is widespread. WIDEspread. Why so little faith from the veterinary community? I have so many patients who are our of options, and believe me, being open minded….we have exhausted so many paths. I see little downside and tremendous upside in autologous stem cell therapies. All you need to do is talk to your colleagues who are engaged in stem cell therapies. They overwhelmingly feel this will be the standard of care in 5 years.

  4. skeptvet says:

    Do you have any evidence to cite for your claims about the safety and efficacy of stem cell therapies? It is hard to understand, if the evidence is so ironclad, why the FDA is warning people that only very limited uses of stem cell treatments are known to be safe and effective. Or why the International Society for Stem Cell Research says this:

    “Currently, very few stem cell therapies have been proven safe and effective…Most of the unproven stem cell treatments for sale throughout the world carry very little promise of actual benefit and very real risks.”

    “Cells from your own body are not automatically safe when used in treatments– The use of a patient’s own cells is called an autologous transplant. However, the processes by which the cells were acquired, grown and then reintroduced into the body would carry risks. Here are just a few known risks of autologous stem cell treatments:

    Any time cells are removed from your body, there is a risk they may be contaminated with viruses, bacteria or other pathogens that could cause disease when reintroduced
    Manipulation of cells by a clinic may interfere with their normal function, including those that control cell growth
    How and where the cells are put back into your body matters, and some clinics inject cells into places where they are not normally present and do not belong”

    There certainly seems to be plenty of “faith” and very little evidence in the veterinary use of stem cells. The FDA has elected not to regulate autologous stem cell treatment, but that only means we are legally free to use them without proving they are safe and effective. proponents have been touting them as a revolution for a decade, yet they haven’t yet come up with the data to prove these claims, and asking for anecdotes from colleagues isn’t how we should be validating our treatments.

  5. art malernee dvm says:

    What ever happened to the definition I was taught of “proven” therapy defined by at least two prospective randomized trials done by independent people? Has the parachute argument changed the definition of proven therapy? Also people say a therapy works. What does that mean? If you say a treatment works does that mean any more than the success of a rain dance?

  6. greg says:

    “All you need to do is talk to your colleagues who are engaged in stem cell therapies”.

    That is it? That is the litmus test that someone with 8 years or so of scientific training should use to decide on whether to invest in a new treatment modality?

    That is truly disappointing.

  7. Steve Sheldon, DVM says:

    If it is good enough for Colorado State University, it is good enough for me. They are currently doing clinical studies, accepting patients for stem cell therapy, and are also engaged in CBD studies for epileptic patients (and in the case of CBD are proceeding despite support from regulatory agencies). Stem cell studies at KSU showed safety and improvement in over 150 dogs treated for OA, and hi efficacy. We are not promising a magic bullet, but rather an FDA approved therapy for pets with few options. I happen to be a rather conservative practitioner, but faced with little options for aging OA patients, have opted to provide stem cell therapies. Again, look a the evidence based medicine in the human field. I happen to believe there is a dichotomy between the academic word and the clinical world. I have been practicing for over 30 years and have been admonished before for doing what is in my patient’s best interests while not getting full endorsement of said procedures from those I consult with on VIN. But I carry on. Good day sirs!

  8. greg says:

    Dr. Sheldon, if you feel that it is in your patient’s best interest to sell them an up to now unproven therapy for a pretty penny, we will have to disagree. I hope it is found to be of use, but I will wait for a bit more information before I purchase a system that I am then married to using.

  9. Steve Sheldon, DVM says:

    Greg, I have done an extensive amount of due diligence on this and any other therapy before I expose them to my patients. Like I said I am a very conservative practitioner and I’m usually the last to jump on a new therapy, even those are FDA approved, Remember that Fort Dodge heartworm injection that lasted six months? I lived in Florida at the time and never used it ( it did not represent a novel therapy in my mind, we currently had good heartworm preventatives and I told my clients “let someone else’s dog use it first”) and then it was pulled from the market for killing dogs. I think another ounce of credibility for regenerative medicine is the fact that nationwide and Trupanion pet insurance companies both cover the procedure! There are varying philosophies to practice in our profession, and I respect all opinions. I always tell clients and I have written about this in many publications, find a veterinarian whose philosophy fits yours. I recently attended lectures at NAVC and spoke personally to orthopedic surgeons from the University of Georgia and Florida. It is hard to scientifically explain how stem cells and PRP work on the cellular level but the clinical responses are positive and have many practitioners ( including board-certified, published and tenured orthopedic professors, who have no histological evidence of why these therapies work) singing their praises. The responses of my patients have been very positive to date. It is def not snake oil. Ask Dixie, she was about to be euthanized (non-responsive to multi modal osteoarthritic therapies), but is now trotting around happily after her stem cell therapy. Autologous type 2 stem cell therapy may prove not to be clinically significant, But for now, I choose to offer it as an option to my patients who have no other good options left. Ask yourself, how many patients have you put through an adequan series, (which is not cheap either), only to have absolutely no clinical effect? What do you tell them before you start Adequan? “Well this will probably help, but we don’t know.“

  10. art malernee dvm says:

    . Ask yourself, how many patients have you put through an adequan series, (which is not cheap either), only to have absolutely no clinical effect? What do you tell them before you start Adequan? “>>>> I tell them I would not spend the money. We cannot fix arthritic degenerative joints yet. That’s why we replace or freeze them when available. Having said that I think adequan is proven therapy for the dog. I think the fda has two prospective randomized trials done by people who we consider independent. I only think that because the fda has approved Adequan. I suspect if I search the internet I could find two such trials. Using stem cells in the office for canine patients would require me to use the parachute argument that you do not need a prospective randomized trial for everything.

  11. Steve Sheldon, DVM says:

    Thanks Dr M. I think this article sums it up nicely, pro and con, so I will end my discussion here. FYI/disclosure, I have no conflicts of interest, I am merely a private practitioner trying to do what’s best for my patients. I love our profession, and I love these discussions as well!http://www.americanveterinarian.com/journals/amvet/2018/february2018/stem-cell-therapy-in-veterinary-medicine

  12. greg says:

    Steve,

    I, too, researched stem cell therapy , albeit several years ago. The allure of being “cutting edge” and all. When I took into account the available data and combined that with the cost that I would have to pass on to my clients, I just did not feel I could justify it. It sounds like you are fairly certain, based on the data that you have seen. And that is what these conversations are about; where does one draw the line.

    My associate at the time actually did stem cell therapy on her lab with djd while working at another facility. He did respond….for about 4 months. and then the effect was gone.

    With that in mind, I went about learning as much on mediating pain control as I could. Perhaps you are on the cutting edge and if it pans out, I will send you an apology. I have no problem with people using therapies as long as they have informed their clients of the truth, whether it be extra label, etc.

    by the way, the proheart you are discussing…..long vindicated. But, I am like you in that regard, I like to have things out for a few years before I jump on.

    Best wishes
    Greg

  13. art malernee dvm says:

    I am like you in that regard, I like to have things out for a few years before I jump on. >>

    Did you wait two years before using Apoquel? I ordered it the first day it became available. The company provided prospective randomized studies and could not keep it in stock due to the demand. If something works it can be shown to work. You do not need to show why it works but more than testimonials are needed. Otherwise we are just getting paid for doing a rain dance.

  14. greg says:

    “Otherwise we are just getting paid for doing a rain dance.”

    I agree

  15. skeptvet says:

    Steve,

    I don’t think anyone disagrees with the idea that when we have no effective therapies for a serious clinical problem, trying plausible but unproven treatments can be appropriate so long as we offer fully informed consent to the owner. My only disagreement is that you seem to believe that individual clinical experiences are sufficient to prove something works regardless of the availability of controlled evidence. That is the same exact case made for homeopathy, faith-healing, and all sorts of nonsense I’m sure you wouldn’t use, and it’s the same that has been used to innumerable treatments that later turned out not to work. Clinical trials are not an academic nicety that would be good to have if possible after the fact. They are the only way we know for sure we really are helping our patients.

    As for OA specifically, there are quite a few therapies with better evidence than stem cells, from NSAIDs to weight loss, so I think you underplay the availability of effective treatments. In some cases, rolling the dice on stem cell therapy may be appropriate. We have actually offered it at my clinic, though we rarely do it anymore since our experience was different and neither clients nor the vet doing it felt there was any dramatic benefit. The challenge of practicing in an evidence-based way is balancing the need to intervene with the uncertainty about the effects of our interventions. I think we agree on the overall process, we just don’t agree on the strength of the evidence for stem cell therapies.

    thanks for the good discussion!

  16. Steve Sheldon says:

    No I did not jump on the apoquel bandwagon and still use it sparingly and somewhat reluctantly. Just something about putting an itchy dog on a kinase inhibitor does not sit well with me. Maybe because I do a lot of oncology work. Some patients respond but I would not put it in the ‘miraculous’ category of pharmaceuticals. Now cytopoint is a different story IMO. When it works it is miraculous! And I believe long-term safety of a monoclonal antibody to be superior to that of apiaurl, which is technically a chemotherapeutic agent. My clinical responses have been far far superior w cytopoint. Alas I fear we are steaying off topic…

  17. Steve Sheldon says:

    You are 100% correct Skepvet. I do think that the science is catching up to the anecdotal evidence. Just look at how many accredited veterinary universities are developing regenerative medicine specialties and labs. I have great faith when Colorado State University, an institute that has earned my respect and my referrals, tells me they successfully treated a canine torn cruciate ligament with stem cells and PRP. That said, Time will tell, as it always does. I still try to adhere by the “do no harm “philosophy of practicing medicine. And I think it is important to remember why they call it the practice of medicine. One thing I know for sure, is that I do not know everything or have all the answers! I’m a much better student of this profession then I was 30 years ago. Thanks for moderating and weighing in.

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