US Stem Cell Inc (USRM)

[Dragon Lady]

Prestigious Journal: Unregulated STEM CLINICS:

From a highly reputable journal associated with the Mayo clinic, one of the finest research hospitals in the world:

https://www.elsevier.com/about/press-releases/research-and-journals/u.s.-clinics-avoiding-government-oversight-of-stem-cell-treatments

"U.S. Clinics Avoiding Government Oversight of “Stem Cell” Treatments

FDA responds with draft guidance documents to close loopholes, according to commentary in Mayo Clinic Proceedings

According to Dr. Turner, U.S. stem cell clinics often make very persuasive claims about how they are complying with federal regulations. While these assertions might seem compelling, they aren’t necessarily true. On the contrary, his review of federal regulations, warning letters, letters written by the FDA’s Tissue Reference Group in response to questions about how the FDA interprets 21 CFR 1271, and new draft guidance documents all indicate that the claims many of these businesses make about regulatory compliance are incorrect.

If the claims that the clinics are relying on are wrong, then many of these businesses ought to have submitted Investigational New Drug or Investigational Device Exemption applications to the FDA. Clinics marketing biological drugs requiring premarketing approval by the FDA are prohibited from advertising and profiting from the sale of investigational agents until safety and efficacy trials are conducted and they have the licenses they require to market such medical products.

“These clinics aren’t going to stop making these marketing claims and performing procedures just because the FDA has issued three new draft guidance documents,” Dr. Turner cautioned. “It is going to take a substantial effort by the FDA to address the rapid spread of U.S. businesses marketing unapproved stem cell interventions. Whether the FDA will make that effort is at present unclear. The last five years of relative regulatory inaction is cause for concern. Perhaps these new draft guidance documents are a harbinger of the FDA providing more effective oversight of such businesses. If not, more patients are going to pay thousands or tens of thousands of dollars for so-called adipose-derived ‘stem cell interventions’ even though there is little or no evidence that they are safe and efficacious for amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, spinal cord injuries, and many other diseases and injuries.”"

FASCINATING STUFF IMO, about "stem cell clinics" peddling NON FDA approved so called "treatments". NOTICE, the journal article specifically mentions conditions such as "amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, spinal cord injuries, and many other diseases and injuries".

Well, gee, lets see- WHERE HAVE WE HEARD vast "claims" (and even "testimonials" aka ANECDOTES) about supposedly "treating" those EXACT maladies/illnesses with supposed fat derived "stem cells"??????

Oh, I can think of one place IN FLORIDA, LOL !! RIGHT ON THEIR WEBSITE.