When you have a condition that doctors struggle to treat, it’s frustrating, scary and depressing. You worry you’ll never get better. You feel like your life will never feel normal again. In desperation, some patients turn to unproven, unapproved treatments at unregulated stem cell clinics. And this decision can bring trouble because many stem cell treatments can be dangerous. But not all stem cell treatments are dangerous. In fact, doctors in reputable hospitals regularly use stem cells to treat patients with cancer and other disorders. So, how do you make sure your treatment is approved and safe? What are the dangers of stem cell clinics?
What are stem cells and how can they help patients?
Stem cells are the body’s raw materials – they develop into cells of the blood, brain, bones, and all of the body’s organs. Because of their ability to transform, “stem cells have the potential to repair, restore, replace and regenerate cells, and could possibly be used to treat many medical conditions and diseases”.
In regenerative medicine, stem cells are guided into becoming specific cells that can be used to replace, regenerate and/or repair diseased or damaged tissues. Additionally, scientists can grow stem cells into new tissue for transplants.
Patients with many conditions might benefit from stem cell therapies, including those with spinal cord injuries, type 1 diabetes, Parkinson’s disease, ALS, Alzheimer’s disease, heart disease, stroke, burns, cancer and osteoarthritis.
What kinds of stem cell treatments are FDA approved?
The FDA oversees stem cell products in the US. Importantly, the FDA hasn’t approved most stem cell treatments. Moreover, the FDA considers many of these treatments illegal. The only FDA-approved stem cell products consist of stem cells derived from umbilical cord blood that can form into blood cells.
Today, doctors routinely perform stem cell transplants, also called bone marrow transplants. In this treatment, stem cells replace cells damaged by chemotherapy or disease. Additionally, stem cells can help the patient’s immune system fight some cancers and blood-related diseases, such as leukemia, lymphoma, neuroblastoma and multiple myeloma. These transplants use adult stem cells or umbilical cord blood.
Interestingly, although bone marrow cells are also used for treatments, the FDA generally does not regulate bone marrow for this use.
It’s important to understand that any other type of stem cell treatment is considered experimental.
What’s the difference between a stem cell clinic and a hospital?
Simply put, stem cell clinics are free-standing facilities, often with little or no government oversight. The government highly regulates hospitals.
Stem cell treatments provided at hospitals are either FDA approved or are part of a clinical trial under FDA oversight. In order to study stem cell products, researchers must show the FDA they are taking steps to help assure the product’s safety, purity and potency. Additionally, researchers must provide data from animal studies to help evaluate potential risks.
In contrast, stem cell clinics may advertise and provide stem cell treatments and clinical trials without FDA approval and oversight. Moreover, some clinics may falsely advertise that FDA review and approval of their stem cell therapies is not necessary. Without FDA oversight, it’s impossible to know if the advertised treatments are safe and/or effective.
That being said, no treatment of any kind is 100% safe. All treatments, whether received in a hospital, doctor’s office or clinic, carry a degree of risk. So do your homework – understand the pros and cons, as well as potential risks, before deciding on a treatment. And don’t let desperation lead you down a dangerous path.
How many stem cell clinics are there in the US?
This is a booming business. There are more than 600 stem cell clinics in the US, touting treatment for a wide range of medical conditions.
The dangers of stem cell clinics.
Many stem cell treatments offered at stand-alone clinics don’t work. These clinics advertise unproven stem cell treatments, promising to treat and sometimes cure diseases, even though they have no scientific proof that the treatments are safe and effective. Instead of helping, most of these clinics waste patients time and money while providing false hope. And sometimes patients are harmed or killed.
What kinds of harm can occur from unproven stem cell treatments?
Clearly, unproven stem cell treatments pose risks and may not cure or treat the disease. The stem cells may:
- Not work as expected.
- Move to unexpected locations.
- Change into inappropriate cell types.
Furthermore, an analysis of scientific journals, clinical case reports and mass media identified harms caused by unproven stem cell treatments. The researchers list of harms includes:
- Loss of vision
- Ventricular fibrillation
- Pulmonary embolism
- Spinal cord lesions
- Gastrointestinal bleeding
- Cardiac arrest
- Internal brain hemorrhage
- Uncontrolled blood loss
It’s important to note that even if a procedure uses your own stem cells, there are still safety risks, such as those noted above. Additionally, if stem cells are manipulated after removal, contamination of the cells is possible.
What is the US government doing about the dangers of stem cell clinics?
The FDA is increasing its oversight and enforcement to protect patients from unscrupulous stem cell clinics. At the same time, they want the medical community to continue their work focusing on safe and effective use of stem cell products.
As part of their efforts, the FDA is taking action against some of the worst clinics. An FDA statement on recent action against an unscrupulous clinic includes the following statement by Action FDA Commissioner Ned Sharpless, M.D.:
“Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients… the FDA will continue to take action—such as issuing warning letters or initiating court cases—against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use.”
Unfortunately, the FDA has not kept pace with this rapidly growing business. So, the marketplace for unproven stem cell treatments continues to flourish.
Make no mistake about it, these stem cell clinics are businesses intent on making money. Because public and private insurers do not pay for unproven medical treatments, including unproven stem cell treatments at these stem cell clinics, patients must pay thousands of dollars for treatments. And this leads to many desperate patients putting their finances at risk.
According to an article in The Washington Post, the Lung Health Institute in Tampa encourages patients to get the money for stem cell treatments by taking out loans and/or borrowing from family members. Furthermore, some patients borrow from their retirement accounts or borrow money against their homes. And some use a credit card for all or some of the cost. All of this can put their financial futures in jeopardy. Finally, some patients use crowdfunding to pay for their treatments, taking money from people who don’t realize these treatments will likely not help.
Aggressive marketing lures customers.
Despite a lack of evidence, stem cell clinics aggressively market their services directly to vulnerable patients who are desperate for help.
The article in The Washington Post examined the marketing and sales techniques used by the Lung Health Institute. Among other practices, the institute bought ads on search engines, so their websites appeared prominently when users search for “cure” and “treatment” for various lung diseases. Additionally, they bought ads on card game sites popular with older patients. And they enticed patients who attended seminars with discounts if they make a deposit on the spot.
Google bans stem cell clinic ads.
In September 2019, Google banned ads selling stem cell treatments. Google released a statement saying it would “prohibit advertising for unproven or experimental medical techniques such as most stem cell therapy, cellular (non-stem) therapy, and gene therapy.” This is a huge step in the right direction! However, these clinics can still reach potential customers through Facebook and other platforms.
What can you do if you’re considering stem cell treatments?
Although stem cell products may potentially treat many medical conditions, it’s still a fairly new science. For almost all stem cell products, the benefits and risks are not yet known. Meaning, other than those that are FDA approved, it’s unclear if a stem cell product is safe or effective.
The FDA advises patients to make sure that any stem cell treatment under consideration is either FDA approved or part of a clinical trial with a plan submitted and approved by the FDA. Before receiving treatment, don’t be afraid to directly ask for proof of FDA approval. Ask for the FDA Investigational New Drug (IND) application number. And you can ask to see the FDA communication acknowledging the IND.
And, importantly, if a clinic tells you that no FDA review or approval is needed because they are using your own stem cells, don’t believe them – that’s not true.
As with any medical treatment, ask as many questions you need until you fully understand the procedure, the benefits and the risks.
Considering stem cell treatment in another country?
Needless to say, you should take extreme caution before going to another country for stem cell treatment. The regulations around stem cells use and research vary by country, so it can be hard to know if a treatment is reasonably safe. Although you can research regulations that cover cell stem products in the country you are considering, the risks may be higher than the potential benefits.
Do your research before selecting any kind of treatment. For more information, read these blog posts:
- Should You Trust Your Doctor’s Recommendations?
- The Dangers of Too Many Tests and Treatments for Patients
- 10 Tips to Communicate Better with Doctors
- Help for Hard to Diagnose Health Issues
- Trustworthy Sources for Medical Information on the Internet
- Should you Speak Up if You Think Your Doctor is Wrong? YES!