![]() ![]() COMELLA, individually, Defendants - Appellants. 0:18-cv-61047-UU UNITED STATES OF AMERICA, Plaintiff - Appellee, versus US STEM CELL CLINIC, LLC, a Florida limited liability company, US STEM CELL, INC., a Florida profit corporation, KRISTIN C. USCA11 Case: 19-13276 Date Filed: Page: 1 of 23 IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT _ No. Furthermore, the procedure does not fall within the 361 HCT/P exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. The procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. ![]() The Eleventh Circuit affirmed, concluding that the Clinic's stem cell procedure does not fall within the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective. The Clinic offers a procedure, which purportedly treats all kinds of chronic conditions, in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient. The FDA filed suit against the Clinic, alleging that the Clinic's stem cell procedure violates the Federal Food, Drug, and Cosmetics Act. ![]()
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