Fetal tissue banking: standards and regulatory issues.
There has been a long-standing interest in collection and study of fetal tissues for the purpose of understanding normal ontogeny, as well as aberrant processes in development. As the unique features and capabilities of fetal tissues have become elucidated, it is evident that fetal tissues could potentially be used to ameliorate adult degenerative diseases through transplantation. Indeed, there has been significant work surrounding the transplantation of fetal-derived hematopoietic stem cells, islet cells, and central nervous system cells. Many involved with collection and transplantation of fetal tissues seem poised on the edge of the federal regulatory playing field. This article discusses the history of regulations related to cellular and tissue-derived products and current regulatory issues facing cell and tissue banks in the United States from the tissue bank perspective and focuses on these issues as they relate to the use of cells derived from fetal tissue.
Newman-Gage
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Northwest Tissue Center, Puget Sound Blood Center, University of Washington, Seattle 98104, USA.
D000328:Adult; D016380:Brain Tissue Transplantation; D016332:Fetal Tissue Transplantation / Q000331:legislation & jurisprudence / Q000592:standards*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D016381:Islets of Langerhans Transplantation; D014015:Tissue Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration