Editor’s note: Wellness Word is an informational column which is not meant to replace a healthcare professional’s diagnosis, treatment or medication.
Scientists discovered ways to extract stem cells from early mouse tissues nearly forty years ago. The initial study of mouse stem cells led to the discovery of a method to derive stem cells from human tissues and grow the cells in the laboratory.
The exciting theory that research scientists are working on is that stem cells can be guided into becoming specific cells that can be used to regenerate and repair diseased or damaged tissues in humans.
Currently, researchers are investigating the use of adult, fetal and embryonic stem cells as sources for specialized cell types, such as nerve cells, muscle cells, blood cells and skin cells that can be used to treat various diseases.
In theory, any condition in which there is tissue degeneration can be a potential candidate for stem cell therapies. Examples include spinal cord injury, blindness, stroke, burns, heart disease, Type 1 diabetes, osteoarthritis, rheumatoid arthritis, muscular dystrophy and liver diseases. However, to date, we do not have good scientific evidence that this can occur in humans.
Although stem cells offer a compelling promise for future therapies, they currently face significant technical hurdles that can only be overcome through years of intensive medical research.
Unfortunately, because the promise for benefit is so large and for so many serious conditions, numerous desperate patients are seeking help at almost any cost.
As a result, the number of commercial cell clinics is expanding rapidly. According to Professor Turner at the University of Minnesota, there were a dozen such clinics in 2009; in 2017, there were more than seven hundred. Unproven cellular therapies are big business, generating about $2 billion annually.
Commercial cell clinics often make claims of benefit and safety not supported by scientific medical research. Technically, these clinics are required by federal regulations to submit stem cell therapies for review as “drugs” and to provide evidence of their safety and efficacy. The US Food and Drug Administration has not enforced these rules, so these businesses are essentially unregulated.
Additionally, stem cell clinics operate under less robust oversight of infection control measures, including injection safety and medication preparation and testing, which potentially amplifies the risk to patients.
In December, the CDC received reports of blood infections in twelve patients from various commercial cellular clinics in three states: Texas (seven), Florida (four) and Arizona (one).
Currently, we do not know whether these treatments are even effective. Reports are rampant that many patients do not benefit from these treatments, and there are numerous lawsuits against commercial cell clinics.
The gold standard for evaluating any new treatment is an adequately sized, randomized controlled trial in which the new treatment is compared against a placebo. To date, there have been no such human trials, despite the fact that many thousands of people are lining up to get these treatments.
The commercial cell clinics are charging very high fees that are not reflective of benefit and safety. A procedure such as an injection into a joint might take about ten minutes and cost between $5,000 and $20,000. For systemic diseases such as lupus, some clinics also administer cells intravenously, which can cost more than $10,000 per session.
Patients should beware. Before paying any clinic thousands of dollars, go to the FDA website for information. Demand that the commercial cell clinic provide you with published medical human research that specifically lists their cellular product by name and demonstrates that product’s safety and effectiveness.
Dr. Hari Dass Khalsa is a chiropractor with offices located in the Hawthorne District. Call 503.238.1032 for more information.