Stem cell research is one of the most controversial subjects to face the world since abortion, yet stem cell research could be the key to unlocking a cure to the deadliest diseases affecting mankind. While stem cells have vast promise for both medical issues and for future approaches such as slowing down aging, scientists are still in the beginning chapter of the stem cell revolution. Stem cell research and the use of stem cells in therapy is a complex multi-step process that requires scientists to comply with existing regulations and guidelines. While the Food and Drug Administration (FDA) regulates stem cells in the United States to ensure that they are safe and effective for their intended use, the FDA’s regulation hurts the development
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The FDA has the discretion to bring criminal charges against anyone using stem cells without FDA approval (Halme & Kessler, 2006). The FDA recommended that scientists comply with the existing regulations and guidelines (George, 2011). The compliance is set to ensure that the stem cells are safe and meet the requirements of the FDA (George, 2011). It is also recommended that in non-clinical trials the stem cell product or stem cell therapy should be tried and tested on an animal before being exposed to a human subject (George, …show more content…
Stem cell therapies consist of human cell and tissue products which have been minimally manipulated in the laboratory by scientists (Knoepfler, 2013). Stem cell therapy is defined by the FDA as a biological drug and classified as a “351” (Knoepfler, 2013). A drug that has been labeled as a “351” by the FDA requires researchers to conduct clinical studies and FDA approved pre-marketing (Knoepfler, 2013). Currently, the FDA regulates stem cell therapy products that have been greatly manipulated in the laboratory by researchers (Knoepfler, 2013). For example, a stem cell clinic claims that they are able to treat almost every disease with the use of stem cells (Knoepfler, 2013). The FDA is authorized by law to regulate stem cell product claims made by medical businesses (Knoepfler, 2013). However, the FDA does not regulate physician conduct, but only drugs and medical procedures (Knoepfler,
The FDA has the discretion to bring criminal charges against anyone using stem cells without FDA approval (Halme & Kessler, 2006). The FDA recommended that scientists comply with the existing regulations and guidelines (George, 2011). The compliance is set to ensure that the stem cells are safe and meet the requirements of the FDA (George, 2011). It is also recommended that in non-clinical trials the stem cell product or stem cell therapy should be tried and tested on an animal before being exposed to a human subject (George, …show more content…
Stem cell therapies consist of human cell and tissue products which have been minimally manipulated in the laboratory by scientists (Knoepfler, 2013). Stem cell therapy is defined by the FDA as a biological drug and classified as a “351” (Knoepfler, 2013). A drug that has been labeled as a “351” by the FDA requires researchers to conduct clinical studies and FDA approved pre-marketing (Knoepfler, 2013). Currently, the FDA regulates stem cell therapy products that have been greatly manipulated in the laboratory by researchers (Knoepfler, 2013). For example, a stem cell clinic claims that they are able to treat almost every disease with the use of stem cells (Knoepfler, 2013). The FDA is authorized by law to regulate stem cell product claims made by medical businesses (Knoepfler, 2013). However, the FDA does not regulate physician conduct, but only drugs and medical procedures (Knoepfler,