Stem cell therapy is a revolutionary technology that continues to make major strides that promise amazing new things, and is also a field of medicine that has many years of research, regulation, and backing behind it. You may be wondering- what are stem cell regulations and how is the stem cell therapy procedure regulated on a local, national, and worldwide level? Within the United States, it is the Food and Drug Administration who regulates this procedure. Read on to learn more about stem cell therapy and the various regulations that are put into place within the United States as well as how it is received on an international level. Call Stem Cell Miami in Miami today for your stem cell therapy consultation.
The Regulation of Stem Cell Therapy Within The United States
Within the United States, stem cell therapy is regulated in a variety of ways. First of all, the agency in charge of regulating medical procedures such as stem cell therapy is the Food and Drug Administration, or the FDA. Within the United States, the Food and Drug Administration has a specified center called the Center for Biologics Evaluation and Research (CBER) which regulates human cells, tissues, and cellular and tissue-based produces (HCT/P) which are intended for any implantation, transplantation, infusion, or transfer into a human recipient. Their jurisdiction include hematopoietic stem cells that are utilized in the processes of the stem cell therapy procedure.There are comprehensive requirements published by the FDA (current good tissue practice, donor screening, and donor testing requirements), to protect against the introduction, transmission, and spread of communicable disease. Allogeneic products hold more extensive regulatory requirements than the regulations for autologous products. Stem cells are extracted from a variety of sources and are utilized in a range of procedures and applications. Stem cells from bone marrow, umbilical cord blood, or peripheral blood are routinely utilized in transplantation procedures to treat patients with cancer and other disorders of the blood and immune system. Unrelated allogeneic use of stem cells that come from cord blood are also regulated by the FDA, and a license is required for distribution of these products. Moreover, the FDA requires a review process in which manufacturers are required to display how products will be manufactured in order for the FDA to be sure that the appropriate steps are taken in order to regular purity and potency.
Stem Cell Regulations Worldwide
On a worldwide basis, stem cell products are transported around the globe every day in order to provide life-saving therapies for patients. Additional regulations may apply for these products that are collected and transported across international lines. Each individual import and export country of stem cell products and procedures will determine their own regulations, and every country may also have their own local, regional, and national regulations on the collection, manufacture, and distribution of cellular therapy products. The World Health Organization have also issued a set of Guiding Principles on Transplantation that greatly influence professional codes and practices as well as legislation around the world regarding such issues.
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Stem cell regulations are the jurisdiction of the FDA within the United States, and worldwide various countries will have their own additional regulations regarding the stem cell therapy procedure. Contact Stem Cell Miami today for a consultation regarding stem cell therapy.