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United States v. Regenerative Sciences, LLC
''United States of America v. Regenerative Sciences, LLC'' was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug Administration (FDA). Regenerative Sciences LLC marketed a therapy procedure called Regenexx-C for the treatment of arthritis and orthopedic injury that involved extraction and culture of mesenchymal stem cells from the same patient which were later reinjected. In 2008, The FDA notified Regenerative Sciences LLC that the procedure may not be in compliance with their regulation using an Untitled Letter, which began a series of suits and counter suits, leading to the 2014 decision upholding the FDA’s regulation of more than minimally manipulated stem cell therapies.
==Regenexx-C Procedure==
The Regenexx-C Procedure was developed by Regenerative Sciences LLC and offered as a treatment for arthritis and other orthopedic conditions. The procedure involves extracting mesenchymal stem cells from a sample of the patient's bone marrow or synovial fluid. These cells are then cultured in the patient's autologous platelet lysate, allowed to proliferate, and mixed with an antibiotic before being reinjected into the same patient at the site of orthopedic injury. This is quite different from the medical procedures the company now offers, which are all fully 21 CFR 1271.15(b) compliant.〔(Regenerative Website-FDA Clarification )〕
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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