Cultured Stem Cells — Court Rules on the Regenexx Case


As discussed in our prior K&L Gates Alert, “Cultured Stem Cells for Autologous Use: Practice of Medicine or FDA Regulated Drug and Biological Product?”, in 2010 the Food and Drug Administration (“FDA”) brought an action against Regenerative Sciences, LLC (“Regenerative”) to permanently enjoin the company from using the Regenexx™ procedure to process mesenchymal stem cells (“MSC”) for the treatment of various orthopedic conditions. On July 23, 2012, the United States District Court for the District of Columbia ruled in favor of FDA and granted its motion for summary judgment and permanent injunction against the use of the Regenexx procedure. This case has been closely watched by those involved in stem cell research and commercialization because of the many legal and practical questions it raises as to the regulation of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) in humans. We provide a brief summary below.

Regulatory Background -

Human stem cell treatments and associated products are regulated by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Public Health Services Act (“PHSA”). As discussed in greater detail in our previous Alert on cultured stem cells, a stem cell-based product can be regulated as a drug and/or a biological product. Under the PHSA, a “biological product” is defined as any “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product . . . applicable to the prevention, treatment or cure of a disease or condition” of humans.

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