In an online search, researchers found more than 570 North American clinics offering unapproved stem cell treatments for:
• aging and sagging skin
• spinal cord injuries
• other joint problems
• lung disease
• Parkinson’s disease
• multiple sclerosis
and many other chronic medical conditions (Cell Stem Cell, June 30, 2016). The U.S. Food and Drug Administration (FDA) has not approved these stem cell treatments as no good data exists to support their use for the many conditions that they are advertised to treat. The FDA has issued suggested guidelines on the use of stem cells and is considering more stringent regulation. It takes a very long time for the U.S. government to shut down illegal clinics that are located in only one state. Individual states are lax to enforce restrictions and the government usually steps in only when there is evidence of interstate commerce.
Stem cell clinics have sprung up in most states, but are most abundant in Arizona, California, Colorado, Florida, New York and Texas. Last year the FDA sent warning letters to clinics in California, Florida and New York for illegally using stem cells from people’s fat tissue to treat conditions such as Parkinson’s disease, multiple sclerosis, amyotrophic lateral sclerosis (ALS) and autism. Some U.S. citizens are traveling to Puerto Rico, China, India and Mexico and other locations to receive these unapproved stem cell treatments.
What are Stem Cell Treatments?
Stem cells are primitive cells that can become specialized cells such as skin, fat, muscle or other tissues. They can help to repair tissue and to generate new tissue cells to replace old red blood cells, torn muscles, old skin and other tissue in your body. For example, research has shown that adult bone marrow cells can replace damaged heart muscle tissue (Mayo Clinic Proceedings, 2009;84:876) and cells damaged by chemotherapy in cancer patients. Stem cells have the potential to replace tissues damaged by disease, but we do not have the research to show that it really works and we certainly have lots of questions about its safety.
You can get stem cells from yourself or from embryonic tissue, usually blood taken from the umbilical cord of a newborn baby. It can be dangerous to receive stem cells from another person because you could have serious rejection reactions to another person’s stem cells. Most of the clinics use stem cells from your own bone marrow, fat cells or blood. For example, they may draw your blood and use a machine to separate and remove your stem cells from the blood. They can also remove your own fat or bone marrow cells, extract the stem cells and give them back to you.
Concerns about These Clinics
• When you have stem cells removed from your own body and then re-injected into you, there is no way to tell if anything has been changed.
• Stem cells taken from you do not appear to be as capable of making new tissues as stem cells that are embryonic cells taken from the umbilical cord of a newborn baby.
• Stem cells from a baby’s umbilical cord are far more likely to have abnormalities that would keep them from growing lasting new tissue.
• Stem cells can trigger an immune response in which your body treats the new cells as it does invading bacteria and kills them.
• The stem cells that you receive in most of these clinics usually have none of the therapeutic advantages that research labs use to make their stem cells more effective. For example, research labs are making stem cells better by manipulating and transplanting DNA genetic material.
• No government agency is checking these unapproved and unregulated stem cell clinics for effectiveness or safety.
• The procedures that are used in most of the clinics have not been approved for the general population.
• Celebrity endorsements and patient testimonials are meaningless.
• The prices charged are often outrageous.
• Health insurance plans seldom cover stem cell treatments done at these clinics.