You mean this one ? It is not a paywall article, so it can be posted here for anyone interested to read
The FDA are likely to appeal, but the judgement supports a good argument .... it is the patients own cells they are using for the treatment after all .... will be interesting how this plays out as I cannot imagine the FDA will like the loss and would have to know that this would open Pandora's box for similar type treatments / providers in the USA,
including the dodgy ones they have shut down in the last few years ? https://www.prnewswire.com/news-rel...ing-lawsuit-brought-by-the-fda-301616731.htmlFederal judge enters judgment in favor of Cell Surgical Network, ending lawsuit brought by the FDASep 01, 2022
RIVERSIDE, Calif., Sept. 1, 2022 /PRNewswire/ -- This week, a federal judge in California issued a landmark decision siding with the California Stem Cell Treatment Center (CSCTC) in a lawsuit brought by the U.S. Food and Drug Administration, ruling that Cell Surgical Network's innovative surgical procedure that uses patients' stem cells to treat a range of medical conditions does not fall under the FDA's regulatory jurisdiction.
The ruling by The Honorable Judge Jesus G. Bernal of the Central District of California is significant for people seeking to utilize their own stem cells as part of medical treatment as well as the licensed medical doctors who provide stem cell treatments to their patients.
"We appreciate the Court's clear and unequivocal ruling, which affirms what we have been saying for 12 years: that our innovative surgical approach to personal cell therapy is safe and legal," said Dr. Elliott Lander, co-founder of CSCTC. "With this victory behind us, we look forward to refocusing our energy on our practice and harnessing life-changing stem cell treatments to support doctors and benefit patients across the country."
The FDA brought the lawsuit against CSCTC in 2018 in an attempt to assert regulatory authority over stem cell therapies. The agency argued that a physician's use of his patient's own stem cells as part of the medical treatment provided to the patient was equivalent to manufacturing a biological drug product and therefore subject to regulation by the FDA.
The court rejected this argument on Tuesday, ruling that the surgical procedure does not create a new prescription drug. The court wrote: "The adipose tissue Defendants remove from patients clearly consists of human cells. And whatever is injected back into patients as part of Defendants' SVF Surgical Procedure and Expanded MSC Surgical Procedure certainly contains such cells."
Founded in 2010 by Dr. Lander, a surgeon and board-certified urologist, and the late Dr. Mark Berman, a board-certified otolaryngologist and cosmetic surgeon, CSCTC has delivered stem cell therapies to more than 14,000 patients. Its surgical procedure involves the removal of patients' fat tissue to isolate stem cells so that they can be deployed to help repair or replace tissues affected by damage or disease.
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