An investigation by the Arizona Republic found 238 unlicensed stem cell clinics. That is just in Arizona! If you extrapolate that figure it suggests there are 10,731 unlicensed clinics nationwide!
How is this possible?
There are many reasons. The stem cell business is still the wild, wild west. The FDA has jurisdiction but simply doesn’t have the resources to police thousands of unregulated clinics. In one instance, the newspaper found a clinic being operated by music teachers.
In most cases, folks who visit these places simply lose their money. Most stem cell products sold in the U.S. contain no live stem cells. The unlicensed clinics are usually selling freeze dried stems cells – if what they cell contains any stem cells.
In order to work, stem cells need to be live. Freeze dry something and you are killing the cells.
If there is a silver lining to this story, the patients who receive these freeze dried stem cell aren’t harmed. yes, they lost between $1000 and $10,000 but physically, they aren’t harmed. If I inject water into my veins chances are good that nothing bad happens.
There are dangers, however. Sometimes these stem cell clinics sell product made by dangerous labs. The products they dispense aren’t sterile or they do contain live cells along with whatever disease the donor may have contracted.
A hospital would never do an organ transplant without loads of testing and steps to insure the sterility of the process. But the makers of stem cell products are often based in someone’s garage. Would you want a heart transplant in a garage? Would you want the person performing the transplant to be a music teacher? But somehow we let our guard down when the transplant is simply a shot.
Many patients are attracted to stem cells after conventional treatments don’t work. The FDA recognizes that stem cells can be beneficial but have only approved the treatment in a handful of circumstances. Unfortunately, we have clinics claim they can cure everything from cancer to male pattern baldness to diabetes.
What the FDA Says to People Considering Stem Cell Therapies
Many of the unlicensed stem cell clinics claim that the FDA does not need to review or approve the treatment. That is false. Worse, some claim they have approval when they don’t. The FDA recommends that if you are considering treatment do the following:
First, ask if the FDA has reviewed the treatment. Ask your personal physician to help you confirm this information. A legitimate clinic should have no objection speaking to your physician. You also can ask for the FDA-issued Investigational New Drug Application number. Ask for this information before getting treatment— even if the stem cells are your own.
Second, request the facts and ask questions if you don’t understand. Make sure you understand the entire process and known risks before you proceed. You also can ask for a short description of the product and information about its safety and effectiveness.
Third, find out who operates the clinic. Often the questionable clinics are not operated by licensed medical doctors or osteopathic physicians.
How Do I File a Stem Cell Lawsuit?
Despite all your questions and due diligence, something bad happens. Now what?
If the product you received had FDA approval and the folks administering the product were properly licensed, consult with a medical malpractice lawyer. (We can help you find someone.) According to the National Institutes of Health (NIH), more than 1,000 clinical trials examining stem cell therapies are currently underway. To date, we have not received any complaints from anyone in an approved clinic trial or from someone receiving an FDA approved product for an approved use
All manufacturers of FDA-regulated stem cell products must adhere to strict FDA safety guidelines regarding manufacturing practices to ensure safety, potency, and purity. When they don’t, they face both criminal and civil penalties.
The problems almost always arise from patients injured by contaminated products. Those are the cases we take. Victims who were injured because of contaminated (adulterated) products have the right to file a stem cell lawsuit for financial compensation, including money to pay for past and future medical expenses, lost wages, pain and suffering, and other damages. (If a patient receives dead cells or if the company selling the cell products makes inaccurate claims about the effectiveness of its products, you may also have a claim for the cost of the treatment – we only consider cases with serious personal injuries.)
Since properly prepared stem cell therapies rarely cause serious complications, you may be eligible to file a stem cell lawsuit if you suffered serious injury due to a stem cell product.
To meet FDA current good manufacturing practices (cGMP) requirements, stem cell companies must maintain a sterile facility to prevent risk of contamination. Live stem cells are often irradiated to ensure no bacterial or viral contamination is present, something that will never happen in a garage based operation.
Stem cell companies must also only market their cells for uses approved by the FDA. Telling patients or doctors that a stem cell product FDA-approved for lymphoma treatment is “also useful for Type I diabetes treatment” is dangerous and illegal.
Many stem cell products are manufactured overseas, making efficient FDA regulation difficult. Others are made in what we call “garage labs” with no clean rooms. Unfortunately, these facilities are usually on no one’s radar and have no insurance.
Working with our national network of dangerous drug lawyers, we can help you receive answers and compensation for injuries. Stem cell products may be the future of modern medicine. Unfortunately, there are far too many companies rushing into the field with untested or dangerous products and making wild claims of miracle cures.
Although we are happy to help if you are injured, know that many of these unlicensed clinics and the labs producing the stem cell products used in these clinics have no insurance. Avoid the pain and suffering by doing your due diligence before receiving treatment.
If the only thing that happened is that you simply lost your money, consider yourself lucky.
To learn more, visit our cornerstone content on stem cell lawsuits. We list the FDA approved products and approved uses for stem cells. We also go into more detail on how you can be harmed from adulterated or nonsterile product. (We also have a cool video on that page.)
Injured and need a lawyer? Contact us online, by email or by phone 202-800-9791. Cases considered nationwide. We do take injury cases on a success or contingency fee basis.