Stem Cells....Snake Oil or Reality?
Searching for stem cell treatment online will give you a huge number of results often offering unproven, and ill-explained, therapies at overseas clinics. Finding a clinic that offers such services in the US is nigh on impossible as the FDA controls the use of stem cells for both research and therapeutic application very carefully. To some this is a problem because it necessarily slows down the rate of availability of treatments, but for others it can, quite literally, save their lives. Whatever problems the FDA has, you can be pretty confident that undergoing stem cell treatment in the US means having a dedicated, experienced, and professional team of qualified scientists and doctors administering the treatment and handling follow-up care as appropriate. You can also be fairly sure that the stem cell treatments you undergo will have been researched professionally and reviewed extensively before being made available to patients.
Clinics overseas are often unregulated or so transient that they simply move from country to country as the authorities catch up with them. The staff at such clinics may well be highly regarded doctors or scientists who are practicing therapies they feel should be made available to all patients in the US now rather than when the FDA decides they are appropriate. However, in many cases these clinics are more concerned with convincing vulnerable patients to part with their money for treatments that are unlikely to offer any health benefits other than a placebo effect and may in fact be downright dangerous.
Controls on health, hygiene, and safe medical practices may not be followed in countries where the government turns a blind eye to such health tourism. Treatments using embryonic stem cells have been, and still are being used in clinics overseas despite safety concerns regarding the uncontrolled differentiation of these stem cells once injected into the body. The origins of such biological material is also questionable in many cases with the Ukraine implicated, a number of years ago, in a scandal involving dubious procurement of foetuses and infants for stem cell therapies.
Clinical trials exist not in order to frustrate patients awaiting treatment but to safeguard patients from potentially dangerous and mishandled therapy. Even after clinical trials have been carried out and a treatment approved there are still many potential problems that can arise in the much larger number of patients treated than those in the trials themselves. Clinical trials can at least avoid some of the more overt contraindications and highlight the need for further research. They also allow patients to receive treatments which are likely to be efficacious and can be covered by medical insurance.
Travelling overseas for treatments often means invalidating the health-care plan in the US and any complications (such as infection, tumor growth, or paralysis) requiring further treatment or hospitalization when back home are often excluded from such plans. Although many clinics in the US offer stem cell treatments the reality is that patients only have their consultation on US soil and then must travel to a clinic in the Caribbean, Ukraine or other country to actually undergo the treatment as it is not approved by the FDA.
Research trials conducted overseas may offer patients a way of accessing treatment but these should be approached cautiously as the regulation of standards in such trials can vary widely. Again, some researchers are perfectly professional and are simply looking to further the field of regenerative medicine without having to adhere to the seemingly overly stringent restrictions put in place by US regulators. Others however, are adept at engaging in methodologically unsound trials which prove to be little more than anecdotal observation and publishing these in a non-peer-reviewed trade journal of their own making. Claiming that a therapy has been proven to work and has had research published to such effect means very little unless the journal, the paper, and the raw data are readily available for other scientists to review and confirm through repeated experiment.
Stem Cell Treatment overseas is often unregulated and downright dangerous
Clinics in Russia, India, Mexico, and Panama are offering treatments with little, if any, clinical evidence to merit their use. Even in the US there are doctors who are using a loophole in regulations to treat patients with their own stem cells despite there being limited evidence proving any benefit from such treatment. These doctors extract stem cells from fatty tissue using liposuction and minimal processing techniques and then inject the stem cells back into the patient all in an outpatient procedure taking around seven hours or so. This treatment is unlikely to be harmful to a patient but is far from proven to be effective for any disease condition. Indeed, the clinics offering such treatment maintain that it is not intended to treat any pathology and is at best a cosmetic procedure. Clearly the establishment of such clinics and the marketing practices defies this supposed intention and is much more geared toward ill and vulnerable patients.
China, well known for offering stem cell treatments to patients despite a lack of evidence for safety or efficacy, passed a law last May requiring clinical trials prior to such treatments being offered to patients. The degree to which this law is being enforced remains unknown, and, as yet, there have been no public announcements of clinics shut down under the new regulations. There are thought to be around 150 clinics in China which offer stem cell therapy for conditions ranging from spinal cord injuries to Multiple Sclerosis, and diabetes. Patients from the US would expect to pay around $25,000 for treatments in Chinese stem cell clinics although the cost of follow-up treatments and possible rehabilitative care in the US is not included in this price.
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