STEM CELL TOURISM: CAVEAT EMPTOR
Stem cell pseudomedicine is on the rise, becoming highly profitable as patients and families are desperate for a cure for devastating and incurable neurological diseases, such as amyotrophic lateral sclerosis and multiple sclerosis. Treatment with “cellular therapy” usually costs between $15,000 and $20,000, is not covered by insurance, and is more widely available overseas than in the US, explaining the concept of “stem cell tourism.” Desperate patients will overlook the lack of rigorously tested scientific evidence and cling to anything, especially patient testimonials found on stem cell tourism web sites. One clinic does “biobanking” of placental cells in pregnant women with MS. The costs are very high to maintain cell viability with the hope of using them in the future for MS therapy. Other companies tout the concept that patients with MS or ALS can biobank their own skin or placental cells to generate “off-the-shelf” stem cells to be injected back into the patients in the distant future when the procedures are proven beneficial in clinical trials.
Many clinics advertise with state-of-the-art web sites, on which celebrities and even physicians give flowery testimonials. Often, they state they are conducting an “observational cohort” study, making the procedures sound official and allowing them to register their study with the government so that it can be found at the generally trusted web site ClinicalTrials.gov.
Physicians, in counseling their patients, must balance patient autonomy with physician beneficence. A hurdle in counseling patients is that the public has a lack of trust in the FDA and a perception that the FDA does not have the best interests of the patient in mind and stalls the development or approval of new therapies. Conspiratorial views are difficult to overcome.
There are real dangers. A child with a rare disease termed ataxia telangiectasia traveled to Russia and received injections into the spinal fluid of neural stem cells and later developed a brain tumor originating from those cells. Two pediatric patients in Germany died because of intracranial bleeding related to injections in a stem cell clinic. A patient in Thailand received stem cell injections directly into her kidney for lupus nephritis. This resulted in a kidney tumor. A clinic in China injected stem cells directly into the spinal cords of hundreds of patients with spinal cord injuries and ALS. There was no benefit, and there were alarming safety issues.
All stem cell therapies are not bogus. There are now several types of stem cells being studied for MS and ALS in reputable medical centers. Stem cell therapies for MS have been done for many years. They can help patients with “fulminant” MS but do not result in a cure.
See JAMA Neurology, November 2015, page 1342.