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FDA stem cells (view source)

Revision as of 03:13, July 13, 2023

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Generally the FDA attempts to block and impede the use of adult stems cells as much as the FDA possibly can, and often beyond what [[Congress]] has authorized the FDA to do.
 
Generally the FDA attempts to block and impede the use of adult stems cells as much as the FDA possibly can, and often beyond what [[Congress]] has authorized the FDA to do.
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== 11th Circuit ==
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The [[Eleventh Circuit]] is the only appellate court to address the issue of the scope of the FDA authority to impede with stem cell therapy, and it appears that the defendant clinic did not really challenge FDA authority in the case:
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{{cquote|US Stem Cell Clinic, LLC, its parent company, and its chief scientific officer (collectively, the Clinic) offer a procedure in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient. This procedure purportedly treats all manner of chronic conditions, from pain to Parkinson's disease.
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The United States Food and Drug Administration is skeptical of the Clinic's claims. It sued the Clinic, alleging the stem cell procedure violates the Federal Food, Drug, and Cosmetics Act (codified at 21 U.S.C. §§ 301 et seq.). 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 appeals, arguing it is exempt from regulation because the procedure falls into either the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. See 21 C.F.R. § 1271.15(b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second 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. We therefore affirm the judgment of the district court.}}
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''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1304 (11th Cir. 2021).
 
== Analogous therapies ==
 
== Analogous therapies ==
  
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