Definitions of Somatic Cell Therapy and Gene Therapy Recently, various innovative therapies involving the ex vivo manipulation and subsequent reintroduction of somatic cells into humans have been used or proposed. Somatic cell therapy is the administration to humans of autologous, allogeneic, or xenogeneic living cells which have been manipulated or processed ex vivo. Manufacture of products for somatic cell therapy involves the ex vivo propagation, expansion, selection (see: "A Proposed Approach to the Regulation of Cellular and Tissue-based Products", Feb. 28, 1997, (62 FR 9721)), or pharmacologic treatment of cells, or other alteration of their biological characteristics. Such cellular products might also be used for diagnostic or preventive purposes. Manufacturers should review policy and regulations to determine how a particular somatic cell therapy or gene therapy product is regulated. Recently, various innovative therapies involving the introduction of somatic cells into humans have been used or proposed. For the purpose of this Guidance, the term somatic cell therapy refers to the administration to humans of autologous, allogeneic, or xenogeneic living non-germline cells, other than transfusable blood products, for therapeutic, diagnostic, or preventive purposes. Gene therapy is a medical intervention based on modification of the genetic material of living cells. Cells may … Continue reading
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