What comes out, must go back in: Court sides with FDA on "same surgical procedure" and "homologous use" definitions governing human cell and tissue products

Hogan Lovells

FDA authority to crack down on illegally marketed stem cell treatments confirmed -

On 3 June a U.S. District Court in Florida issued a decisive blow against US Stem Cell Clinic LLC, granting the U.S. Food and Drug Administration's (FDA) motion for summary judgment, and stopping the clinic from offering its stem cell therapy to patients. The court found that the population of stromal and vascular cells in the clinic's therapy, known as stromal vascular fraction (SVF), constitutes a biological drug product that FDA must review and license before it can be commercially marketed. The court also found that the clinic's manufacturing procedures and its promotion violated statutory requirements, causing the clinic's cellular product to be adulterated and misbranded. Critically, the court rejected the clinic's argument that because its SVF procedure merely extracts and reinserts cells during the "same surgical procedure," it is exempt from FDA regulation. Instead, the court adopted FDA's view that the clinic's separation of stromal and vascular cells from surgically removed adipose (fat) tissue disqualified the procedure from this exception. The court held that the exception only applies to a procedure where the human cell, tissue, or cellular- or tissue-based product (HCT/P) that is implanted into a patient includes "all" of "the antecedent HCT/P removed from the patient in its original form." The case is a critical ruling supporting FDA's increasing enforcement against stem cell clinics. It also clarifies FDA's authority to regulate SVF therapies in particular, and bolsters FDA's effort to gain more control over the HCT/P field more broadly.

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