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.