![]() ![]() ![]() Patients should always be wary if a clinic advertises a patient-funded clinical trial. Patients should ask clinics for documentation from FDA that they are conducting a clinical trial under an active investigational new drug application, also known as an IND. These claims are false.Ĭlinics often advertise that they are conducting clinical trials using these products. They may claim that their registration with FDA or an FDA inspection equates to FDA approval or a form of FDA endorsement. Some clinics may falsely advertise that it is not necessary for FDA to review and approve their stem cell therapies. The FDA regulates stem cell and exosome products in the United States. The FDA has not approved any exosome products for any uses. If the products are being used for arthritis, injury-related pain, chronic joint pain, anti-aging or other health issues, they have not been approved by FDA and are being marketed illegally. (Read FDA’s warning about stem cell therapies external icon )Ĭurrently, the only stem cell treatments approved by the Food and Drug Administration (FDA) are products that treat certain cancers and disorders of the blood and immune system. Be sure to get all of the facts if you are considering any stem cell treatment. These products may have the potential to treat many medical conditions and diseases, but further research is needed to know whether the products have any benefit or whether they are safe to use. While all medical treatments have benefits and risks, unapproved stem cell and exosome products expose patients to potential risks without a clear benefit. ![]()
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