Quite frankly, Dr. Patty...

I think as long as the decision is laid out exactly as you have stated in this article...the decision should be left to the owner. And if you as my vet have a personal opinion, and I am your client, and I value your opinion, IN ADDITION to you providing the benefits and risks, I will most likely ASK for your personal opinion, and use it's weight in making my own decision. If someone has the finances to opt for this treatment, understanding that in your professional opinion, it is experimental, and they wish to go forward...then so be it.

Pet owners make difficult decisions all the time...do we go forward with bloat surgery on a dog that is already in extreme distress? Do we subject our pet to chemo and radiation when they are diagnosed with cancers? Do we amputate a leg with osteosarcoma, or treat palliatively until the pain can no longer be managed?

You bring up a "new" procedure which may or may not offer relief to our pets. But owners need and deserve the facts on both sides. And everyone should be getting at least, a second opinion, on any major procedure from another competent, and trusted professional.

My sister suffers from a serious back issue which cannot be corrected...but can be relieved with injections, which are HIGHLY painful for days...but then provide months of relief. Who is to say that the temporary pain is not worth the relief?

Making health decisions on our pets is as complex and individual as the decisions we make for our children or ourselves. But they must remain ours. And as long as vets continue to provide unbiased information to their patient's owners...and are willing to provide their own professional opinion, if needed and requested...I think we will be just fine.

Great article!

Wow, wouldn't expect YOU to be on the 'against stem cells' side! I am one of the owners who had this done for our Jasmine. We feel that it was worth every penny. More over, our vet who was just curious at the time we came to him, after seeing what it did for Jasmine is now excited about it also.

He is an old time practitioner and had seen a lot through his time. I believe he can tell where things would have been as opposed to where they are with Jasmine who is now 7.5 years old and in spite of her many medical ordeals acting like a puppy.

Now, Jasmine's fat at that time was taken from he shoulder, which is somewhat less invasive, and following treatments were done with stem cells stored from the original retrieval and stem cells grown from retention samples. The retrieval is a one time deal only.

She had her first treatments in combination with her knee surgeries plus injections into her arthritis shoulders and IV dose for her arthritic neck two years ago. Her knees were bad for a long time before finally diagnosed and were in a bad shape. Her knees and shoulders and doing remarkably well, in spite of the shape they were originally in.

More over, she is not on any NSAIDs. In fact, she even couldn't be, as she almost died when we tried. So much for safety of that. Plus should she have remained on the NSAIDs, the cost would have been over $100/month for her, so the accummulated cost wouldn't be much less and the risk the her internal organs substantially higher.

The bottom line is that her originally arthritis ridden body DOES NOT NEED NSAIDs!

This treatment isn't that young, dogs had been treated since 2005. Yet it was still quite a novelty in 2008 when we decided to go with it.

Yes, I wish there was no anesthesia involved, but to me that is the only downside. Anesthesia is needed for retrieval and direct injections only, it is not needed for IV treatment (for immune mediated conditions for example).

Until recently, most dogs who got this treatments were dogs who were on the death row due to their arthritis, when NSAIDs either couldn't be used or weren't effective. It was the last resort for these dogs, who would otherwise had to be put down, and it saved their lives!

Seeing is believing. And we see what stem cells did for Jasmine every day.

We'd do it all over again.

Sure, horse owners are willing to try stem cell therapy... because insurance companies are willing to pay for it! It's not technically difficult, but there is very little proof it's helpful at all for orthopedic conditions. Too bad. It's a lucrative procedure.

An excellent resource: www.closerlookatstemcells.org

The site was created by the International Society for Stem Cell Research (ISSCR), a group with this philosophy (from the website): "...rigorous standards in the development of stem cell therapies and outlining what needs to be accomplished to move stem cells from promising research to proven treatments." We're just not there yet.

While stem cells are an active and promising direction of research in a variety of fields, they are not an acknowledged therapy. The word therapy implies a known benefit. Just because an action does not cause obvious harm, does not mean that licensed professionals who have taken an oath to do no harm, should take money from people, and give hope to them, to take that action. The decision making of the medical professional leading to whether to engage in an activity, must be made based on the educational foundation and current knowledge. That's what the honorific of being a professional rests upon. Basing one's actions on what might be true or what one hopes is true, a guess, is more the mark of a charlatan. There will always be ill people concerned family members and animal owners, desperate or otherwise, willing to part with their money on an unsubstantiated hope. Yes hope springs eternal.
The bigger question, for each medical professional, is "how do I want my reputation and self assessment to read?" Do I see myself more like Claude Bernard, the father of physiology or perhaps more like Samuel Hahnemann, cognitor of "nosodes."
Just because something can be done, does not mean it should. The professional knows the difference.
Arnold L. Goldman DVM, MS

Although I wouldn't opt for this procedure at this point, if/when stem-cell treatment for feline CRF has a lot more data and has a high likelihood of helping, I would consider it in a heartbeat.

The downside to CRF is that the procedure would probably need to be done before the kidney numbers get too high due to the dangers of anesthesia with a CRF kitty.

Thank you for an excellent article, Dr. Khuly.

Interesting, This is taken from deep fat? if this works for Pet-Kids, why not people ? I've know a lot of People who have left the Country, to have unproven procedures, trying to live a-little-longer or to stop the pain.I know this has not worked for any-one so far, False Hope, not to mention the money.We need to think with our heads, not our hearts. Until this or other Procedure is proven. We need to back off. That is what I think anyway.

Yes, exactly. Just because veterinarians can do something, doesn't mean we should. Do some dogs and horses improve after stem cell treatment? Yes. Would some of these patients have improved without stem cell treatment? Yes. Hence the confusion for desperate owners.

Using this perspective, what are the odds that dogs who were headed for euthanasia because of their debilitating arthritis just get better on their own?

Though it sounds counterintuitive, the probability that this type of patient might improve without stem cell therapy is NOT zero.

See: http://www.closerlookatstemcells.org
Go to "Top Ten Things to Know about Stem Cell Treatments", Point #4: "Just because people say stem cells helped them doesn't mean they did". There's some information about the placebo effect (obviously not applicable to a dog, though it does apply to the owner and veterinarian), but the rest does apply.

Also see SkeptVet's comment, specifically, re: patients that cannot achieve a good quality of life with conventional treatments.

I appreciate this point of view. Bottom line is, we did the treatment for Jasmine and we are happy we did and I am glad it's available.

However subjective our point of view might be, Jasmine is doing great and therefore we are happy and would do it again.

She cannot have NDSAIDs, since she almost died when we tried putting her on them and her response to other pain medications is questionable.

At 7.5 years of age and considering all the issues her body faced, she is doing better than not only before the treatment but since we can remember.

What we were hoping to buy with this treatment was a happy dog who can enjoy her life. We got that.

Good article! When I was at the North American Veterinary Conference last month, stem cell therapy seemed to be one of the buzz themes, and one of the issues was exactly what you've written about: does it really work?
I felt that Bob Harman, of www.vet-stem.com, addressed this really well in a lecture titled "Stem Cell Therapy for Canine Athletes: Evidenced-based Medicine". He went through all the different layers in the pyramid of evidence-based medicine, from in-vitro studies up to randomised placebo controlled studies. His conclusion was that, done properly, stem cell therapy has ticked all the boxes.
Now as you point out, this type of lecture isn't the same as a peer reviewed publication, and the speaker has a commercial interest. But I have to say that he was very convincing!
I'm not sure if he's published this talk elsewhere, but it's worth looking out for. The full contents are available in the NAVC proceedings.

Pete
www.petethevet.com

Are the trials done? Is there clear data that shows evidence of improvement that is NOT subjective? I actually go to a clinic where one of the Vets was/is part of the original Vet-Stem trials. Interestingly enough when one of my dogs became more and more lame and NSAIDs were not helping I had to ASK about the treatment. It was explained. They evaluated my 70# shepherd. Afterwards I met other owners from my clinic and another clinic and then I declined. The procedure to evacuate fat/stem cells from her shoulder seemed really invasive. Granted my dog has never had any open wound type of surgery but another dog from a different clinic had prolonged complications. The dog's shoulder wound dehisced several times. The complications delayed the purported treatment for the hind limbs and ultimately made life more difficult for the dog. Yes the risks were explained to me but it seemed experimental and too invasive at the time. I do keep hearing about the procedure in the news and from other people. It's been about 3 years since I evaluated the procedure perhaps it's now better? Granted in my desperate search to alleviate the pain for my dog led me to agree to an epidural injection....that in the long run did not help either. who knows if the stem-cell would have helped.

Check out the website:

http://www.closerlookatstemcells.org

There's a section entitled "What to Ask".

Interesting. I guess I considered this treatment longer than 3 years ago...since my previous google search did not yield that site. I suppose one needs to consider like Dr Patty said....How desperate are we? I understand that this is all extremely exciting research. I must admit in addition to how experimental the treatment appeared. It was very $$$ and I'm familar with human trials where some of the costs are covered.

Hi Dr. K,

What a fabulous blog post! Quite the professional conundrum this stem cell therapy has created for those of us who rely on evidence based medicine.

Dr. Khuly,

I'm happy to offer my take on the stem cell question, especially since this seems to be a subject on which I am all too easily misinterpreted. I certainly wouldn't call myself a "naysayer," for example. As I've said repeatedly, I see great promise in stem cell therapies, and I am cautiously optimistic that they will eventually be a useful tool.

My concerns have more to do with the widespread and aggressive marketing of a therapy in advance of adequate evidence to demonstrate safety and effectiveness. We are all familiar with drugs that had great promise, and that passed far more extensive pre-market testing than stem cells have undergone, and which later turned out to have less benefit than hoped or unexpected hazards (e.g. Vioxx, thalidomide). There have also been many procedural treatments like stem cell therapy which have come on the scene, enjoyed great popularity, and then turned out to be less useful or more dangerous than hoped (e.g. internal mammary artery ligation). The lesson is that the way things seem isn't always the way things are, and good quality research isn't just a nice extra, it is critical to making the best choices for our patients.

"Given the reality that the pets most affected by this are those with conditions that are untreatable by any conventional means, and that time-consuming clinical trials would require onerous delays in treatment, is it wrong to keep this therapy out of owners' hands?"

I think you may be unintentionally setting up a bit of a false dichotomy here. You seem to be assuming that all the pet owners clamoring for this new treatment are those whose pets have serious arthritis symptoms that do not respond to currently available treatments. (The vast majority of stem cell treatments in small animals, which is my field, are marketed and used for arthritis, so that is what I will address here. As you point out, other applications are primarily still only available in the context of academic research). I am not aware of any objective statistics, but I suspect this isn't true and that the market for stem cell therapies would be very small if it were limited to such cases. I frequently field inquiries about this therapy from people who have not taken full advantage of existing available treatments for arthritis, the most popular application for autologous stem cell treatments.

There are many therapies for arthritis which are well-established to be effective. Weight loss, physical therapy, non-steroidal anti-inflammatory medications (NSAIDs) are the most common examples. The majority of patients with arthritis respond well to these therapies. However, there is no free lunch in medicine, so anything with a benefit is going to have a downside.

Meaningful weight loss requires restricting a pet's calorie intake significantly. The pet is going to be noticeably hungry and likely to beg or scrounge for food, and this is understandably hard for many owners. I spend a lot of time counseling owners on nutrition trying to prevent and treat obesity, but the reality is that many owners are not able to stick to a serious weight loss regime for their pets, particularly for older and relatively inactive pets.

Physical therapy is a great intervention, but it has its costs as well. Some are financial, and there is a significant investment in time and energy as well as money for owners seeking this kind of care. We are fortunate to have dedicated physical therapy facilities nearby, but not all veterinarians can easily offer or refer for this treatment, and not all owners readily take advantage of it.

And then, of course, there are NSAIDs. I would never consider denying that they have potentially serious side effects, but the evidence is very clear that, when properly used and monitored, they are very effective and very safe for the overwhelming majority of patients with severe arthritis (e.g. http://skeptvet.com/Blog/2010/12/safety-and-efficacy-of-nsaids-for-canine-arthritis/). Unfortunately, appropriate concern about potential side effects easily becomes irrational fear, and some pet owners avoid NSAIDs unnecessarily.

There is definitely a balance to be achieved between the need to act and the uncertainty about whether our actions will help or harm. For those patients who cannot maintain an acceptable quality of life using existing treatments with well-established benefits and risks, I have no objection at all to offering stem cell treatment as an experimental approach. Ideally, this would include some kind of objective, structured assessment of outcomes, both beneficial and unintended. Casual assessment by owners and individual veterinarians, or uncontrolled research by companies selling the therapy, will always show a benefit and miss all but the most dramatic side-effects for any therapy, so this can't be our only form of assessment.

I think it is instructive to look at how differently stem cell therapies are being handled in human medicine. The major organization representing stem cell researchers, the International Society for Stem Cell Research, has said:

We have all heard about the extraordinary promise that stem cell research holds for the treatment of a wide range of diseases and conditions. However, there is a lot of work still needed to take this research and turn it into safe and effective treatments.

The International Society for Stem Cell Research (ISSCR) is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective.
Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy.

Remember, most medical discoveries are based on years of research performed at universities and companies. There is a long process that shows first in laboratory studies and then in clinical research that something is safe and will work. Like a new drug, stem cell therapies must be assessed and meet certain standards before receiving approval from national regulatory bodies to be used to treat people.

(Stem Cell Therapy – Still an Uncontrolled Experiment on our Pets.)

These people have devoted their careers to studying stem cell therapies, so they can't simply dismissed as "naysayers" as so often happens when skeptics such as myself raise concerns. Stem cell therapies are moving forward much faster in veterinary medicine than in human medicine not because we have better data or a more serious problem to be addressed, but because we have more lax regulation and fewer concerns about lawsuits if something goes wrong. Hopefully, in the end this will turn out to be a good thing because these therapies will be proven safe and effective. However, we cannot totally ignore the possibility that proceeding without rigorous pre-market testing and post-market surveillance will lead us to doing harm unintentionally, or wasting time and resources on an ultimately ineffective therapy.

Just to be completely clear:

1. Stem cell therapy is indeed a promising, though as yet unproven, new therapy. However, only clinical trials can truly show it to be safe and effective, or not, so our current headlong rush into this field based on preclinical findings and individual patient anecdotes is not without risks.
2. Given the uncertainties about the safety and efficacy of this expensive and invasive procedure, all other treatments with established risks and benefits should be utilized fully before we turn to stem cell therapy. This includes NSAIDs which, though not without risks, are very effective and generally much safer than most of my clients seem to think.
3. For those patients who cannot achieve a good quality of life with established treatments, it is perfectly appropriate to offer stem cell therapy as an option. In human medicine, such treatments are generally available through clinical trials or special "compassionate use" provisions. This may not always be practical in veterinary medicine, but we should make our best effort to objectively and systematically assess the outcomes of patients treated with stem cells.

Think about how long it took for us to make the connection between certain vaccines and cancers that developed rarely and many years later. If a similar unanticipated risk exists with stem cell treatment, we're going to miss it if we are looking carefully, and that would be irresponsible. I would like to see less aggressive, more fact-based marketing and more effort given to evaluating objectively the benefits and unintended effects or complications of these procedures.

You ask if we have the right to keep a potentially beneficial therapy with uncertain risks and benefits from owners who want it. I would phrase the question differently. Do we have a right to sell owners a potentially beneficial therapy with uncertain risks and benefits, often through misleading and unjustifiably positive marketing? Don't we have a responsibility to ensure as best we realistically can the safety and effectiveness of any therapy we offer our patients?

Here are quotes from peer-reviewed papers:

Tapp et al, Exp Biol Med (2009) 234:1-9
"ASC [adipose-derived stem cells] have proven to be a useful source of stem cells in bone and cartilage repair"

Frisbie & Smith, Equine Vet J (2010) 42(1):86-89
“Current literature supports the use of mesenchymal stem cells (MSCs) for treatment of orthopaedic problems.”

Does this mean all questions have been answered? No, of course not. But the evidence is overwhelmingly in favor of stem cell therapy. Regarding safety, here is another quote:

Sensebe et al Vox Sanguinis (2010) 98:93-107
"MSCs [mesenchymal stem cells]have been used in clinical trials since 1995; currently, more than 80 trials are registered with ClinicalTrials.gov and no significant adverse events have been reported."

>>Does this mean all questions have been answered? No, of course not. But the evidence is overwhelmingly in favor of stem cell therapy.>>

I don't agree, at least not in its current incarnation. Do I think it's a promising area of research? Yes. Do I offer stem cell therapy to my clients whose horses have failed conventional therapy? Yes. Some horses are helped. Some aren't.

It's an expensive therapy. I think clients have a right to know it is not a cure-all.

It is one thing to demonstrate that ASC's can form various cell types in vitro or in vivo, and its quite another to demonstrate clinical efficacy. There are no credible controlled studies in either humans or animals to demonstrate clinical value of ASC injection into osteoarthritic joints.

Regarding the articles you have cited:

1) Tapp et al (2005) is a review article. The authors did not provide any comment on the use of ASC's in the treatment of osteoarthritis, either in animals or people. They cited one study (Dragoo et al, Tissue Engineering. July 2007, 13(7)) that reported transformation of ASC to a hyaline-cartilage producing cellular phenotype when surgically placed within a chondral defect in rabbits. To extrapolate these results to a clinical recommendation for ASC injection for OA would be unwarranted and scientifically irresponsible.

I do not have access to Frisbie and Smith's review article, but I am familiar with Frisbie's published study on ASC for OA in the horse from 2009 (J Orthop Res 27:1675–1680). In that study, Frisbie and his fellow researchers at Colorado State failed to document a compelling case for stem cell injection. In their words, "the findings of this study were not significant enough to recommend the use of stem cells for the treatment of osteoarthritis represented in this model." In the year and a half or so between when that paper was submitted and when the review article was published, there were no breakthrough clinical reports on ASC for OA, either in people or animals.

The bottom line is that we presently have no strong data to characterize ASC injection for OA. Anecdotal (testimonial) and proprietary data are hardly the stuff of solid evidence-based medicine. We owe our patients and clients a better effort.

Here's another link to a peer reviewed paper:

https://secure.vlsstore.com/Media/PublicationsArticle/VTX_08_04_272.pdf

"Effect of Adipose-Derived Mesenchymal Stem and Regenerative Cells on Lameness in Dogs with Chronic Osteoarthritis of the Coxofemoral Joints: A Randomized, Double-Blinded, Multicenter,Controlled Trial"

It was only 21 dogs (recruited from 4 vet clinics) but this was the conclusion: "dogs with OA of the coxofemoral joint that were treated with intraarticular injection of Adipose Derived-Mesenchymal Stem Cells demonstrated statistically significant improvement in lameness compared with a blinded, saline-injected control group and significant improvement over time from baseline."

When you read the report and look at the detail, the effect isn't magical, but there does seem to be a distinct positive result......

Pete

I see nothing wrong with trying unproven medical care as long as the client is informed that studies show unproven medical care is more likely to harm than help. Thats why it needs to be called investigatory medical care so the client is not promoted a unproven remedy against the odds of helping. The FDA only approves about 20% of the drugs submitted and thats after millions of dollars spent in multiple RCT testing studies. Vet medicine has a long history of promoting economically conceived unproven medical as a profession since the 1970s. These are to get clients into the office rather than for medical reasons. Our text books even say its ok to give care thats not needed if it gets the client in every year. For example annual revaccination of pet promotions. You do not get revaccinated every 1-3years with the same vaccine and neither should your pet but Current Vet Therapy says its ok to revaccinate with unneeded vaccine every year if it get pets into the office every year. . Also special toxicities or sensitivities are promoted in dogs by the profession, for example sugerless chewing gum and rat poison, that would not be a concern by human doctors in children getting the same dose per pound when the LD50 for humans and dogs are about the same and special sensitivities in prospective dog trials are always negative.


Definition of quackery quoted from “Alternative” Health Measures published by AMA p 5: It is the promotion of an unproven product or service. The operant word is promotion rather than intent.
. Further definition quoted from “Alternative Health Measures published by AMA p 5: Fraud: the FDA has defined health fraud as promotion of an unproven remedy for profit.
•••
FDA definition of fraud quoted in Sept/Oct 93 NCAHF Bulletin Board: The deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate, or done without adequate knowledge or understanding of the article. (Quoted from a letter from M L Frazier - Director, State Information Branch 6/18/93).

art malernee dvm
fla lic 1820

If we are not certain that an action we wish to take is more likely to do good than harm, then we are just as uncertain that the same action may not do more harm than good. This is and remains the problem with so-called alternative and complementary approaches to disease. There can only be actions that are effective and those that are not. We should always strive to first do no harm.

If unproven therapies are offered by colleagues at no charge, there can be no conflict of interest. It is when they are charged for, and profitable, that self interest becomes admixed with real concern for the patient. Unproven therapies will always suffer this shortcoming. Hence, unless offered for free as compassion, I personally eschew all such methods. Just because something can be done, does not mean it should be.

See below, especially paragraph #2:

Veterinarian's Oath

Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health, the relief of animal suffering, the conservation of animal resources, the promotion of public health, and the advancement of medical knowledge.

I will practice my profession conscientiously, with dignity, and in keeping with the principles of veterinary medical ethics.

I accept as a lifelong obligation the continual improvement of my professional knowledge and competence.

If unproven therapies are offered by colleagues at no charge, there can be no conflict of interest. >>>>>

I vaccinate a good number of dogs and cats every 1-3 years that are going into boarding kennels and dog parks like the one at Disney World. I tell my clients that another revaccination meets the FDA definition of professional organized medical fraud but the FDA does not regulate pet vaccines. I do not charge the client for the unneeded vaccine but charge for the office visit. That works because the vaccine only cost me a few dollars and I can get paid to tell the client the vaccine i am about to give is not needed and ask them if they would get their child revaccinated for polio just so they could go to Disney World. If I paid a hundred dollars for a rabies vaccine like human doctors do my no charge for the vaccine would not allow me to stay in business. From a practical standpoint i think its ok to charge for unproven medical care as long as the client knows its more likely to harm than help if thats what you need to do to stay in business and keep others from ripping off the public promoting unproven medical care in the market place.
art malernee dvm
fla lic 1820

With all due respect Dr. Malarnee, repeating a proven preventive measure, immunization, more often than necessary for liability reasons of others (kennels, theme parks, manufacturer-proved duration of protection) that may be unnecessary is a different animal than offering a nifty sounding intervention that as yet is unapproved for therapeutic use. I don't dispute that immunization is not without adverse effects or that the duration of protection may well be, is even likely to be longer than the manufacturer will allow us to know, but I am always suspicious of therapies looking for diseases to treat. That happens when trendiness is allowed to trump the deliberate, thoughtful scientific process. As I said, if our colleagues who offer certain interventions "early" were willing to do so at no charge, on a compassionate use basis, much suspicion would be allayed. This is often not the case, with some practitioners seeming to be ready to jump on every new bandwagon, and make hay until the science comes out defrocking the intervention, or the next greatest thing makes it to the news.

I guess you could say a homeopathic remedy's "is a different animal" because the ingredient (water) is a "proven preventive measure" but in my opinion stem cell therapy, revaccination of pets every 1-3years and homeopathic all are unproven medical care and in my opinion promoting any three of them at this time as a medical intervention meets the FDA definition of fraud.
art malernee dvm
fla lic 1820

Agreed!