03 Sep Understanding The Relationship Between Stem Cells And the FDA

Stem cells are a relatively new therapy that exists in the medical world. As such, there are many questions surrounding stem cell therapy in an attempt to get a better understanding of how they work and how they will fit into the medical world in the future. One of the most common questions to arise around stem cell therapy is how it relates to the U.S. Food and Drug Administration (FDA). Understanding this relationship can help people to have a better understanding of stem cells and how they work as a viable treatment for a variety of ailments.

           The FDA is the federal organization responsible for protecting public health. They do this by ensuring the safety, efficacy, and security of various drugs and foods. The FDA is a big name in the medical field because once a new drug or treatment has the FDA stamp of approval, it can be widely used among the masses in the United States. This does not mean that there are no risks associated with the drug. Rather, it means the drug has been deemed more effective than it is dangerous to the patient. 

           One of the most common questions people ask when they are learning about stem cell therapy is whether or not stem cell therapy is approved by the FDA. Stem cells that are amniotic derived cannot be FDA approved. This does not mean they are not dangerous or is not worth it. Rather, they cannot be FDA approved because they are a biologic. However, this type of tissue is regulated by the FDA meaning the biologic must be obtained and handled in specific ways set forth by the FDA. 

           Within the United States, the FDA allows for minimal manipulation in regards to stem cells. This means there is no culturing of the cells allowed in order to expand cell count. In addition, no additives or enzymes can be added to the cells in order to change their biologic structure. In addition, the FDA regulates the labs through which stem cells are processed. For this reason, it is important to go to a lab that is regulated by the FDA.

           Many people associate FDA approval with a meaning that the drug or therapy is safe and effective. Thus, they believe if a product is not FDA approved then it is not safe or not effective. This is an incorrect viewpoint. Stem cell therapy is revolutionary because it uses human biologics as the primary form of treatment. Biologics can never be approved or denied by the FDA. There are plenty of testimonials that show the effectiveness of stem cell therapies. These patients have tried a plethora of FDA approved treatments without any improvement in their conditions. Yet, when they undergo stem cell therapy, a therapy that has not been approved by the FDA, they see their best results. The FDA is an important governmental body for keeping United States citizens safe. However, understanding how the FDA works will give you a clearer picture of what FDA approval or regulation means when it comes to stem cells.