Female scientist performing laboratory testing

Stem Cell Therapy – Buyer Beware

Recently a patient with advanced lung disease asked me my opinion on stem cell treatment for lung disease. They had attended a seminar about the benefits of stem cell transplant for a variety of medical conditions, including COPD. According to the patient, this presentation was given by a physician who operates centers that provide autologous stem cell therapy, harvesting stem cells from adipose tissue and returning them to the patient through intravenous infusion. The patient left the seminar with the impression that this was an FDA approved therapy and, while not covered by insurance, would only cost about $10,000 out of pocket. What is our role as clinicians when approached by patients interested in receiving controversial treatment that has not been thoroughly evaluated and established as standard of care?

As clinicians counseling patients on any new treatment, first we have to be clear in our own minds what our understanding of such new therapy is. If we do not have any authority on the subject, we might serve our patients best with a simple statement of “I am sorry. This is not standard therapy and not in my area of experience. I feel I cannot help you.” At this point, it may be appropriate to refer the patient to someone with knowledge or experience of the treatment who might be able to offer more guidance. Even if she feels her understanding of the treatment her patient is considering is limited, the clinician may be able to assist the patient some by helping the patient understand some basic principles such as what clinical research entails and how therapies are proven safe and effective. It is also important for people to understand that therapies administered in other countries, even novel therapies in the United States, may not have quality control to ensure safe medications or processes.

Right now, the world of translating our understanding of stem cells in a laboratory setting into safe and effective treatments is still a bit like the wild west. More and more researchers and physicians are pursuing the new treatment possibilities offered by stem cells and are offering treatment to patients even though the long term safety and clinical efficacy of these treatments has yet to be clearly established. All medical innovation does need to start somewhere. However, oversight is needed to ensure that implementation of such novel treatments is done as safely and ethically as possible. Currently there is considerable controversy about who should be providing this oversight, agencies like the FDA or professional organizations and regional physician credentialing agencies. Patients should be helped to understand that since this is a relatively new field, there are few well established standards and some confusion about who is ensuring patient safety. Because of this lack of standards and clear oversight, patients need to be their own advocates and make sure they understand the risks of new therapies.

Helping patients understand the value of informed consent is also important. It is not just another form to sign in order to start treatment and patients should be encouraged to ask questions and actively participate in this process. These treatments affect their lives (and often their pocketbooks), it is crucial they understand what the expectations are, what the risks are, what costs there might be, and what is being done to ensure their safety. Even without knowing the details of a treatment, we can help patients consider what types of questions they should have answered as part of the informed consent process.

For now let the buyer, our patients, beware. There is a lot of information out there on stem cell therapy and it can be confusing to the average person. News agencies cover stories of “miraculous recoveries” such as Gordie Howe’s improvement after stem cell treatment following a stroke. Stem cell treatment centers may use vague language and some rely heavily on the testimonials of patients who perceive benefit from their treatment. For someone suffering from chronic illness that strongly limits their quality of life, the hope offered can be very persuasive. As clinicians, we should take some time to help our patients understand how to evaluate novel therapy choices so they can make the decision that is best for them.


The International Society for Stem Cell Research offers some great tools for patients interested in stem cell therapy. There is also patient handbook available on their website which could help them make more educated decisions about the stem cell therapies that are currently available.


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