Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations

Stem cell therapies offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist. Cell based therapies are one of the most promising new fields of science and medicine. These products hold tremendous potential for transformative and potentially curative treatments for some of the most devastating diseases and conditions challenging us today.  For several decades now, stem cells obtained from the bone marrow or peripheral blood have had an established role in providing valuable treatment for patients with certain cancers, like leukemia, and certain other serious diseases and conditions, such as aplastic anemia. But most forms of regenerative medicine are still in early stages of development and adult stem cells and stem cells from birthing tissues have not ...

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