It’s been about four years. And, believe it or not, the FDA still has not shut down these fly-by-night stem cell clinics. They never even filed for a TRO (temporary restraining order).
But, finally the FDA is suing US Stem Cell in federal court (Ft. Lauderdale), claiming it is “openly violating the law and endangering patients”. Meanwhile that firm grossed about $ 7KK last year (from its three clinics and from training countless other doctors [at least 150 are known to be trained last year; their total training has exceeded 700 docs]).
Four years. After leaving folks blind, instead of improved. Still selling folks false hope for Parkinson’s disease, MS (multiple sclerosis), spinal injuries, and more.
US Stem Cell derives its stem cells from either belly fat (liposuction) or bone marrow. (Note that the belly fat is the more suspect process. Bone marrow stem cells reinjected back into the same patient may actually work.)
How does US Stem Cell obtain stem cells from belly fat? They add an enzyme to the liposuction mess (the enzyme breaks down tissue matter), and spins the mixture in a centrifuge. The isolated mesenchymal stem cells are then injected into the patient’s joints, spinal fluid, or even the bloodstream. (Hopefully, no longer into anyone’s eyes.)
The impetus behind these clinics is that way back in 2005, the FDA allowed folks to extract stem cells from patients and reinject them into the same patients- as long as they were “minimally manipulated”- via chemicals, enzymes, or processing. That regulation remained until 2015, when the FDA issued a draft guidance that stipulated when FDA approval was needed.
Kristin Comella (of US Stem Cell) also runs the “Academy of Regenerative Practices”- basically a legal defense fund for clinics that the government plans to shut down. She, a ChemE, is also the Scientific Director of US Stem Cell. And, she is vehemently opposed to these new guidelines. (I know you want me to keep politics out of this- but I can’t. Kristin has managed to get a bunch of GOP operatives involved in her fight against the FDA- and its next adversary- the State of New York.)
For example, the Florida legislature was preparing a bill to require stem cell clinics to be registered with the Florida Health Department- meaning annual inspections and a physician in each office. (Remember, she is a ChemE, not a doc. And, her newly obtained PhD cost all of $ 2700, from an unaccredited ‘virtual university” in Panama. [Panama College of Cell Science].) That proposed measure was axed.
But, the FDA is, as I said earlier, finally acting. The FDA asserts that US Stem Cell is providing a drug, subject to agency approval. But, US Stem Cell asserts that they are offering a surgical procedure- one that is beyond the authority of the FDA. (The FDA is not empowered to regulate the practice of physicians. Then, again, a ChemE is not a physician.)
And, now, the New York State Attorney General is suing a Manhattan clinic (Park Avenue Stem Cell), asserting they are using fraudulent and illegal advertising (for their stem cell procedures). About the same time that the FDA delivered 20 letters to various stem cell mills telling them to cease and desist- they are selling unapproved products in violation of federal law.
Stay tuned…
It figures that in Flori-DUH the proposal was axed.
I am going to use that moniker, Marcia! Thanks for the comment.
Do you think those that try stem cell procedures are at their wits end and hope it will work?
Hope it will work- yes. At wit’s end- only a few, but that’s a judgment call. The problem is that these charlatans are allowed to promise things they can’t deliver.
We are back to the days of snake oil for sale, Martha.
Thank heavens for New York. Taxes are sky high but sometimes (in certain matters) we get what we pay for. Meanwhile the federal government win’t Issue a recall on a baby device some other countries have banned or severely restricted.
Well, we know why the government is not acting in the interest of the people. That won’t change until 2021 or 2025, Alana.