Stem Cell Clinic Takes On FDA Regulations In 11th Circ.

Law360 (January 13, 2021, 8:12 PM EST) -- A Florida clinic urged the Eleventh Circuit on Wednesday to throw out a ruling barring it from offering a stem cell procedure to treat various illnesses, arguing that a lower court erred in finding that the treatment is a drug subject to U.S. Food and Drug Administration regulations.

During oral arguments held via videoconference, counsel for US Stem Cell Clinic LLC and US Stem Cell Inc., which take fat tissue from patients, isolate so-called stromal vascular fraction cells in the tissue and implant the SVF cells back into the patients, insisted that it qualifies for a pair of exceptions to FDA...

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