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The FDA Continues Its Mission To Warn The Public About Unapproved Biologics

The injection of stem cells and other unapproved biologics has gotten out of control. This is true all throughout the United States, but it is a major problem here in Florida. Unfortunately, many patients are unaware of the risks of stem cell therapies and regenerative medicine therapies. As a result, they fall prey to unscrupulous providers. Thankfully, the U.S. Food & Drug Administration has been publishing warning letters to the public over the past few years.

Important Patient and Consumer Information About Regenerative Medicine Therapies

In this June 2021 report, the FDA addresses individuals who were either hurt or had a negative side effect following a regenerative medicine product or a similar product. They alert people who were charged for these products or offered these products outside of a clinical trial that they were likely being deceived and offered the products illegally.

The FDA warns that these regenerative medicine products have significant risks. The safety concerns are many. They include blindness; tumor formation; neurological events; bacterial infection; reactions at the site of collection and administration; unwanted inflammatory or immune response to the cell or therapy; failure of the therapy to work as anticipated when approved treatments are available; and cross-contamination with bacteria, viruses or mold.

FDA Warns About Stem Cell Therapies

In their “FDA Warns About Stem Cell Therapies” article, the FDA warns that “stem cells have been called everything from cure-alls to miracle treatments. But don’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures - and confirm what’s really being offered before you consider any treatment.”

The FDA has some strong advice for individuals who have had stem cell therapy either recommended or prescribed to them. Such patients are encouraged to ask their medical providers if the FDA has reviewed the treatment. They are also advised to contact a clinical investigator in order to get the FDA-issued Investigational New Drug Application number to review. Getting this information confirmed before getting treatment is vital, even if the stem cells are your own.

Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes

In this article, the FDA expresses its concern over the many patients who seek cures and remedies from products that are illegally marketed. In some cases, the medications are not proven to be safe or effective. Sometimes, the medicines have significant safety issues that put patients at risk. The FDA wants consumers to be informed about how these products are regulated and what to look for when considering treatment with one of these products.

“Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood,” the FDA alerts, “These products are approved for use in patients with disorders that affect the production of blood (i.e., the ‘hematopoietic’ system) but they are not approved for other uses.”

Are you considering stem cell therapy or a regenerative medicine product?

If so, it would be extremely wise to discover how it is regulated and whether or not it is FDA-approved. The FDA urges people to either call 800-835-4709 or email with their questions. You may also contact the clinical experts at Allegiant Experts with your questions by calling 407-217-5831 or

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