by Dr. John Goudreau, DO, Ph.D.,

Are you considering traveling overseas for a medical procedure to treat Parkinson Disease (PD)? Medical tourism for "restorative" stem cell therapy to treat PD is the rapidly growing practice of traveling across international borders for health care. More than 50 countries identify medical tourism as a national industry.

Medical tourism is marketed by dozens of private for-profit clinics from Guatemala to China, mainly through internet and patient-to-patient communications. These companies claim to help patients with a variety of illnesses, especially incurable conditions such as PD, while offering little or no scientific evidence.

For decades, doctors have been using adult stem cells from blood, bone marrow and umbilical cord blood to treat cancers of the blood like leukemia and lymphoma. Unlike mature nerve cells, stem cells can replicate, making them potentially powerful weapons against many neurological diseases, including PD. Adult stem cells can be harvested from numerous sources - including one's own bone marrow or from umbilical cord blood. Subsets of cells collected this way are considered "pluripotent" - the cells can mature into any type of cell in the body. Once multiplied and conditioned, the pluripotent stem cells can be injected into the blood stream, spinal fluid via a lumbar puncture, or directly into the brain. Adult stem-cell treatments, often arranged by American-based intermediaries, run between $10,000 and $35,000, depending on the treatment (other travel costs are extra).

Adult stem cell therapy for PD carries a significant risk of complications. Pluripotent stem cells can form cancerous tumors. Stem cells harvested from other people can carry infectious disease and usually require anti-rejection medications for the foreign cells to survive. The only published series on patients receiving adult stem cell therapy for spinal cord injury in China showed a majority of patients suffered complications, while none appeared to benefit. Finally, the pursuit of unproven alternative therapies abroad can be an obstacle for the use of proven effective therapies or clinical trials available in the United States.

Medical tourism for stem cell therapy is often a journey of hope for people struggling with the accumulating ravages of PD. The proper way of establishing that a new treatment is safe and effective through the Food and Drug Administration (FDA) may seem to slow for some. People hope the pluripotent stem cells, like magic bullets, will provide immediate benefit by finding their way to correct targets and developing into the appropriate cell types to repair PD-damaged brain regions.

Medical tourists for stem cell therapy often claim some success when they return home. Peer-reviewed documentation of these claims is conspicuously absent. While there may indeed be a therapeutic benefit to peripherally delivered stem cells in PD, anectdotal statements of improvement are no substitute for clinical proof of effectiveness. Some reports of improvement may be a placebo response, or a desire to believe that the money spent had to have been effective.

Stem cell clinic Web sites and brochures highlight stories of success, often including scientific articles from animal studies to give the appearance of effective treatments. They over-promise their treatments' benefits, while grossly downplaying or ignoring risks. Some sites even cite the few clinical trials using fetal brain cell transplants, instead of the adult stem cell therapy they actually are offering.

Not surprisingly, "magic cure by stem cell" medical tourism has been criticized for consumer fraud, blatant lack of scientific justification and disregard for patient safety. There is potential physical, psychological and financial harm to patients, as well as the general lack of scientific transparency and professional accountability of those profiting from these clinics. If patients undergoing unproven and unregulated stem cell therapies abroad develop serious complications, then the progress of legitimate clinical research could be undermined.

Let's not demonize all innovative stem cell therapeutic approaches, including those delivered outside the United States. PD patients have legitimate and ethical motivation to pursue all avenues of treatment available, particularly given the shortcomings of current proven therapies in some cases. Nevertheless, there is a clear distinction between the commercial purveyance of unproven interventions and legitimate attempts at medical innovation outside of traditional medical research. While medical breakthroughs have evolved from medical innovation, novel medical approaches to treatment must undergo rigorous scientific and ethical review, as well as have appropriate measures for patient protection.

Fortunately, there are steps to avoid falling into a medical "tourist trap." Here are a few examples of key questions and potential "red flags." This list is not comprehensive and additional information, including what to ask before agreeing to undergo an unproven therapy, can also be found at the International Society for Stem Cell Research Web site: www.isscr.org/clinical_trans/pdfs/ISSCRPatientHandbook.pdf.

Some key questions to ask about unproven therapies being offered abroad

Have pre-clinical studies been published, peer-reviewed and repeated by other experts?
Do the providers have independent committee approval, e.g., Institutional or Ethics Review Board, to ensure risks are as low and worth any potential benefits, and that patient rights are being protected?
Do the providers have approval for the safe conduct of clinical trials or medical use of a product for PD from a national or regional regulatory agency, e.g., FDA or the European Medicines Agency?
What are the alternative treatment options for my condition?
If I have this treatment, can I participate in otherclinical trials or have other interventional treatment options?
What compensation am I entitled to if I am injured as a result of participating in this therapy?
What are the total costs of the treatment and what does this include?
What would be the costs of emergency treatment, if needed, should a complication arise?

Red Flags raising concerns about a medical tourism facility

Claims of efficacy only based on patient testimonials
Claims of multiple diseases being treated with the same type of stem cell
Unclear documentation of the source of the cells or how the treatment will be done
Claims of little or no risk
High cost of treatment or hidden costs
Suggestions that repeat treatments may be needed if not initially successful

 

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