When you have a condition that doctors struggle to treat, it’s frustrating, scary, and depressing. You worry you’ll never get better. You’re sick of being sick. In desperation, you may feel tempted to receive treatments at an unregulated, free-standing stem cell clinic. But the dangers of stem cell clinics should not be ignored.
Importantly, stem cell treatments at free-standing clinics can be quite dangerous, as compared to hospital-based treatments (although all stem cell treatments come with risks). In general, free-standing stem cell clinics are for-profit companies focused on money, not patients. So, how do you make sure your stem cell treatment is approved and safe?
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 can potentially 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, HIV, and osteoarthritis.
HIV success stories.
Importantly, stem cell transplants have cured a small group of HIV patients. In the most recent case, announced in February 2023, the patient has no detectable virus in his body, even after stopping his HIV medication four years ago. Excitingly, these transplants are not just putting the disease into remission, they are curing patients.
However, these success stories are the exception, not the rule. Firstly, the stem cell donors in these successful cases each had the same HIV-resistant mutation, which only 1% of people have. And some HIV patients are too sick to undergo this risky procedure. Nonetheless, it’s a great development!
What kinds of stem cell treatments does the FDA approve?
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, yet clinics offering non-proven stem cell treatment operate throughout the US.
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. Therefore, no one is making sure patients are safe in stem cell clinics. On the other hand, the government highly regulates hospitals, including research conducted in 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.
Importantly, 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 choosing a treatment. And don’t let desperation lead you down a dangerous path.
Here’s an infographic that shows the major differences (source):
How many stem cell clinics are there in the US?
This is a booming business.
As of March 2021, there were 1,480 U.S. businesses operating 2,754 clinics selling purported stem cell treatments for various indications. These clinics do not have FDA-approval and they lack solid evidence that they provide safe and effective treatments.
Importantly, this represents a 4x increase in the number of these clinics in a 5 year period!
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 analysis revealed potential dangers of stem cell clinics, including:
- 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.
An 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 treatment deposit on the spot.
Importantly, some non-approved stem cell clinics post their therapies on ClinicalTrials.gov, leading people to falsely believe the clinics are running legitimate, rigorous clinical trials.
And some clinics take advantage of the power of personal stories by posting videos with patients explaining how much stem cell treatments helped them.
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 the 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 they don’t need FDA review or approval because they will use your own stem cells, don’t believe them – that’s not true.
You can learn more on the International Society for Stem Cell Research website.
Finally, as with any medical treatment, ask questions until you feel you fully understand the procedure, the benefits and the risks. And don’t ignore the potential dangers at stem cell clinics because you are desperate for a cure.
Considering stem cell treatment in another country?
Importantly, 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 Medical Tests and Treatments.
- 10 Tips to Communicate Better with Doctors.
- Help for Hard to Diagnose Health Issues.
- Can You Trust Medical Information Online?
- Should you Speak Up if You Think Your Doctor is Wrong? YES!