FDA Dismembered by California Stem Cell Clinic


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May, 2023

In a stunning reversal of FDA power to regulate stem cell medicine, a California court recently upheld the right of a stem cell clinic to provide stem cell treatments to patients using a patient’s own stem cells. In the Court case, the FDA relied solely on their “guidelines” that a patient’s stem cells are a drugs under FDA regulatory power, and presented no evidence at the trial.

As was seen with the “Covid” pandemic wherein voices of reason and alternative opinions of licensed physicians were censored and squelched, this very important case for the patient’s freedom of medical choice has been hammered by 95% or more of news outlets. Or ignored altogether hoping it will go away. It should be recalled that stem cell therapy has been embraced worldwide as a major therapeutic advance that can cure or control our most dangerous diseases and medical conditions. Whole countries stand behind the stem cell procedure related in the California Stem Cell case, which is to take fatty abdominal tissue from a patient, harvest the stem cells, and re-inject into the same patient. But not in the US.

Essentially all recent news articles and editorials convey the prayers that the case will be overturned on Appeal. Good luck with that. This agency, usually headed and controlled by the pharmaceutical industry,  presented not a shred of evidence at trial and therefore has nothing whatever to appeal about. In actuality, the appeal is a favor, which will lead the case eventually to the Supreme Court where this agency will likely be put in its place once and for all.

It is important for practitioners as well as our students to understand the case and the arguments that were involved. This will lead to an understanding as to why the Court ruled against the FDA, and why stem cell treatments involve the authorized practice of medicine and not the manufacture of drugs!

The FDA lost the stem cell case because you are not required to comply with the requirements of the statute if you are a physician that removes stem cells from a patient and implants such into the same patient during the same surgical procedure. Tissue consisting of human cells intended for implantation or transfer into the same patient are beyond the statutory regulatory authority.

An excellent video discussing the case and the statutes involved by a spokesperson of California Stem Cell Treatment Center:

Another shorter  summary of the case and its implications for expanded stem cell therapy in the United States can be downloaded Here:

Federal Court Ruling Favors Stem Cell Therapies



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