Dr. Steven Novella at Science-Based Medicine recently posted about a publication from the International Society for Stem Cell Research which cautions people seeking stem cell therapies that most such treatments are unproven and experimental. This is an especially compelling advisory coming, as it does, from an organization committed to the study of stem cell therapies, and so presumably positively biased in favor of these treatments, at least in principle. It shows an impressive degree of scientific integrity.
The portions of the document that are most telling are the general introduction and the discussion of the limitations of current evidence for stem cell treatments, as well as the discussion of the need for detailed informed consent prior to any use of such therapies, given that they are experimental. In the introduction, the organization states:
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.
In answer to the question “For what diseases or conditions are stem cell treatments well established?” they write:
The range of diseases for which there are proven treatments based on stem cells is still extremely small. Disorders of the blood and immune system and acquired loss of bone marrow function can, in some cases, be treated effectively with blood stem cell transplantation.
Doctors have been transferring blood stem cells by bone marrow transplant for more than 50 years, and advanced techniques for collecting blood stem cells are now used clinically. Umbilical cord blood, like bone marrow, is often collected as a source of blood stem cells and is being used experimentally as an alternative to bone marrow in transplantation.
Other tissue-specific stem cells may also play a role in tissue transplants that have been performed for several years. For tissues and organs such as skin and cornea, stem cells contained in these tissues contribute to long-term regeneration.
Other stem cell treatments are still experimental. This means that it has not yet been shown that this treatment is safe or that it will work.
This is clearly all the more true in veterinary medicine, where the sources of stem cells are sometimes atypical (such as fat-derived autologous cells) and the amount of good quality clinical research on the safety and effectiveness of such treatments is close to nil. And yet, these therapies are being sold and used in clinical practice, quite likely without the kind of detailed informed consent, assiduous follow-up, or other controls for bias and risk that would be expected in a clinical trial.
Once again, this is an example of a plausible therapy rushed to market without adequate evidence of safety or benefit. Such therapies rarely live up to their initial promise, and they expose the public to unnecessary risk as well as false hope. They also expose the professions of scientific medicine to rightly criticism about the impact of profit motive on our behavior, and to less legitimate criticism about the dangers of conventional medicine (and you know what will be suggested as the alternative….). We have a responsibility to our patients, clients, and our profession to be cautious in utilizing unproven treatments and in making sure clients understand the uncertain risks of such procedures.
Jasmine had stem cell treatment (fat-derived adult stem cells from her own fat tissue) two years ago. It worked for her beautifully.
We are very excited about the treatment and would do it again in a heart beat. There are many testimonials to the great benefit the dogs who received the treatment enjoy.
When we were considering this treatment and researching it, it made sense to us and it felt right. To this day over 5000 animals have been treated for arthritis and orthopedic injuries.
I believe that the risk associated with this treatment is minimal, far lower than with some other treatments for the said conditions.
Jana,
From your several comments on various arthritis-related posts, it is clear that you regard testimonials and individual experiences as reliable evidence for what works and what doesn’t in medicine. I wish this were true since it would make my job a lot easier and we wouldn’t need to do research at all. Sadly, we are more likely to do harm than good by trusting our personal experience, as the history of medicine illustrates. If you really are open-minded, I hope you will take the time to browse the arrticles here, and at my main site, which discuss why we are so often wrong when we think we know what works and what doesn’t. Our lives are all so much bettter because science-based medicine has learned to compensate for our individual weaknesses in making such judgements, and there is a lot we can all learn about how to make the best choices for our pets.
There are dogs who are still being euthanized as a result of the debilitating effects of their arthritis. How does that make our lives better?
It is often these patients that end up VetStem’s patients. If they area able to continue on to live quality lives, how does that make our lives worse?
Stem cells are an exciting area of research, and I think there is reason to hope they may end up be a useful treatment for arthritis in our pets. Unlike some interventions I discuss on this blog, I don’t think this one should not be used. I simply think it qualifies as experimental, and it needs to be used with all the safeguards for patients and all the appropriate processes for gather information on safety and benefits that any new experimental therapy ought to have.
The history of medicine is littered with interventions that seemed like a good idea and which later turned out to be useful or harmful. Remember bloodletting? Or thalidomide?
If VetStem has guessed right, then rushing their process to market without adequate testing won’t have done any harm. But if it doesn’t actually work, then we’ve subjected a lot of animals to sedation or anesthesia, surgical removal of fat, and injections into joints (all of which have risks and costs) for nothing. And if there are dangers we don’t know about, we could have another thalidomide, with animals developing cancer, immune-mediated disease, or other possible causes of suffering due to the procedure.
I support the interest in stem cell therapies and the research that’s beginning to get started, I just don’t support selling an inadequately tested therapy to people and subjecting their pets to it without adequate evidence that the potential benefits outweigh the risks and costs.
I must disagree with you. Yes, we need clinical trials and science based medicine. but if you take your own fat and place these cells into a joint, there is very little difference than placing a Kenalog injection or PRP (plasma riched platlets) or Synvisc.
We do harm in medicine when we do commando procedures that are approved. Low risk is the key. I have put fat into faces for more than fifteen years, hundreds of patients, with wonderful results and no infections or issues. All Adipocyte Derived Stem Cells are is a concentrated portion of the fat cells. This is safe, effective and I can only tell you that if we wait for the university to finish the prospective trials, nothing would get done.
We have initially great results from twenty patients who were ready to under complete joint surgery and more than 80 percent have avoided total joints after six months, but we do follow them closely.
I question whether one can so confidently assert the safety of a practice based solely on the clinical experiences of an individual. The suprises that often greet us when we take drug from Phase I-III clinical trials, in which it seemed quite safe under controlled conditions, into widespread use seem to illustrate that low frequency adverse events are hard to detect without systematic, objective, and relatively comprehensive monitoring. And while I agree that the evidence is sufficient to indicate that adverse events associated with autologous stem cell therapies are not common or immediate, I think the possibility of delayed or low-frequency problems cannot be excluded.
Which means, of course, that reasonable evidence of benefit should be available before we take the likely low but ultimately uncertain risks associated with these therapies. And, again, I question whether we can confidently assert these benfits based on clinical experience alone. Such a foundation for belief in medical interventions has failed us time and time again, which is why controlled clinical research exists at all. I don’t agree that nothing gets done if we wait for reasonably good clinical evidence, and I think history shows quite clearly that we make terible mistakes when we don’t. We will never have perfect evidence, but at this time we have virtually none, despite your confidence in your own experiences.
We are considering stem cell implant therapy for our 10-yr-old Great Pyrenees/Lab mix, Miss Pooh. She has severe bilateral hip dysplasia and elbow dysplasia in right elbow. We are considering stem cell injections in both hips, both elbows, and both knees.
I know this is experimental; however, I am especially concerned that I can’t find empirical information on whether Miss Pooh’s prognosis will be negatively affected by her age and the fact that her arthritic degeneration began in both hips and right elbow at a very early age (i.e., at 1 year).
I would appreciate any insight you might have.
Thank you,
Cecelia
P.S. I love your web site.
Of course I can’t offer specific advice about Miss Pooh since I’m not her veterinarian. I can tell you that the more severe the degenerative joint disease is, the less responsive it is to established therapies such as anti-inflammatory medications, and I would expect the same would hold true for stem cell treatment. And there are some concernes about sedation and surgery in older dogs, so depending on the type of stem cell procedure your vet is using that can present some risk.
As for the stem cell therapy itself, as you say it is still experimental and we really know very little about the possible risks and benefits. That’s why it is not currently legal to use this treatment for humans except in registered and approved clinical trials. I think if the arthritis is bad enough and established therapies haven’t helped, it isn’t necessarily wrong to try something experimental, you just have to understand that the risks and benefits are unknown and so the outcome is unpredictable.
Best of luck to you and Miss Pooh.
Hey, your link is broken for the patient handbook just to let you know the new URL is at
http://www.isscr.org/home/publications/patient-handbook
Take care and love your blog,
Sheldon
http://www.appliedstemcell.com
Thanks!
This blog is asking the same questions I am asking about stem cell therapy for veterinary treatment. I’m happy Rana was able to obtain a good result for her pet, but she is missing the point of this blog. Stem cell therapy is being advocated with no data for all kinds of diseases and injuries for a variety of species. My dog has 2 bulging lower thoracic discs, she is a younger, very active golden retriever. I wanted to know what the research was and the treatment protocols for stem cell therapy for dogs with intervertebral disc disease and there is none. I wanted to know specifically data broken down by breed, age of the dog, injury/disease category, etc. as I have worked in biostatistician and in cell biology, but there is no data. I’ve already gone the underwater treadmill/cold laser treatment route for temporary relief at a cost of $2,000, but before I plunk down almost $3,000 I want to see some papers. Well, there are none. If it doesn’t work, that means I have spent the same amount on alternative therapies when I could have gone to the tried and true surgical route that is known to work. At this point in time, given there is no research, I am inclined to go the surgical route and just relieve my dog of her pain burden. As a note, at the small animal clinic where stem cell therapy cases are referred to, the success rate appears to be around 50%, the majority of the dogs being small and geriatric in the cases where it was successful. I have a large & active dog, it gives me pause to think about stem cell therapy for my golden when the success rate is so low.