In September 2019, the U.S. Food and Drug Administration (FDA) issued a warning to consumers: “Watch out for unapproved stem cell therapies!” The warning comes from the agency in response to the mounting concern of patients seeking cures and pain remedies who are vulnerable to stem cell treatments that are illegal and potentially harmful.

Stem cell therapy has gained a reputation for serving as a miracle treatment for repairing diseased tissue, purportedly healing ailments from arthritis to cancer. However, there is a great deal of information that has yet to be learned about stem cells and much of the claims remain unproven.

The FDA has only approved a few stem cell therapies, yet over the past few years, they have witnessed clinics across the country promising miracle results for chronic pain, Alzheimer’s, and cancer; touting these cures as FDA approved.

The FDA wants consumers to be aware that dishonest and unscrupulous stem cell clinics are preying on the vulnerabilities of patients desperate for a cure. Many of these treatments, which are often very expensive, have not been proven effective by medical evidence and are not approved by the agency. The Food and Drug Administration is responsible for protecting the public health and their warnings should not be taken lightly.

“This is yet another example of how people in desperate search of a medical cure fall prey to those who only care about money, that value profits over patient safety. We must be careful not to be taken in by these profiteers. And, when they harm people, we must be thankful that our Constitution guarantees each of us the right to hold wrongdoers accountable for the harm they cause,” advised medical malpractice attorney Sean Domnick, a Shareholder at Domnick Cunningham & Yaffa.

Before any patient considers stem cell therapy, they should first ask their health care provider to confirm it is agency approved and request an FDA-issued Investigational New Drug Application number, even if the stem cells are your own. You can also visit this FDA website to see a list of FDA approved stem cell products.

What are Stem Cells?

According to the Mayo Clinic, “Stem cells are the body’s raw materials — cells from which all other cells with specialized functions are generated. Under the right conditions in the body or a laboratory, stem cells divide to form more cells called daughter cells.” Used in therapies such as injections, stem cells have the potential to provide replacement cells for any part of the body — blood, brain, bones, or organs.

What are the Dangers of Unregulated Stem Cell Injections?

In 2018, a Centers for Disease Control and Prevention (CDC) report documented bloodstream infections in several patients who had received stem cell injections that were not approved by the FDA. Infection types included bloodstream, joint, and epidural abscesses caused by e-coli. In the most disturbing cases, patients suffered blindness, intense stabbing pain, lengthy hospitalizations, and even death after receiving a stem cell injection.

While the future of stem cell therapies is promising, leading researchers believe there is still much that needs to be understood in order to safely administer stem cell therapy. In the interim, patients do not have to allow predatory clinics and doctors to place profits over patient safety by luring them in with false hope. A patient who has suffered the dangers of unregulated stem cell injections could contact a medical malpractice attorney for help. Call today.

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