"Will the disturbing, but important topic of the 3 women who were recently blinded by a fat stem cell clinic in Florida come up? It should. At last week’s FDA science meeting on stem cells, Dr. Albini presented the cases of 3 women who were literally blinded by a Florida stem cell clinic at which fat stem cells were injected into their eyes. Interestingly, it is possible that that the so far unnamed clinic may itself be presenting at the meeting so I’m wondering if someone will have the courage to confront them about this disastrous outcome." Ya see, right as the big FDA "meeting" took place, a "science" session with "big hitter" FDA folks took place as a side-bar. And those FDA SCIENCE PEOPLE, heard from a real M.D., an true "medical expert" about patients being BLINDED at a lil ole S. Florida "stem cell clinic" a little LLC corp. Imagine that? SHAZAM. Gotta "sticky" the whole truth IMO, the entire "FDA meeting" info.
THIS, THIS WAS presented to FDA OFFICIALS during the ole "meeting week", to some "heavy hitters" of the FDA "science" side of things:
"Negative stem cell clinic outcomes in the U.S. include 3 blinded women Posted on September 8, 2016 What can go wrong with unapproved stem cell clinics? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S.
Thomas Albini, MD gave a talk entitled, “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”.
Stem cell clinic transplants of fat stem cells led to blindness in three women, reported Dr. Albini.
We’ve heard encouraging news about how stem cells might help patients regain lost vision or preserve existing vision in the face of a disease like macular degeneration in the future. There’s real potential there with rigorous clinical trials that are ongoing.
Here in this very different case we heard from Dr. Albini about how stem cells inappropriately used by a stem cell clinic in South Florida reportedly caused 3 women to go blind. All had retinal detachment potentially, Dr. Albini said, due to the fat stem cells taking up residence and resulting in pulling of the eye tissue internally. A nurse practitioner reportedly did the transplants rather than a physician. The patients assumed, we were told in the talk, that the listing in clinicaltrials.gov of the “trial” meant the interventions were legit.
This is such a deeply tragic case we can only hope that more people aren’t blinded from this kind of stem cell clinic offering. More on this situation here at Nature by Heidi Ledford.
Michael Miller, MD, PhD, spoke next with his talk entitled, “Glioproliferative Lesion of the Spinal cord Arising from Exogenous Stem Cells.” This case already has had quite a lot of media attention and involves stroke patient Jim Gass, who ended up with a large spinal tumor that dramatically negatively affected his health. We have to give Mr. Gass huge credit for having the courage to go public with this case. He got ES cells and allo MSCs both in China. Then he traveled to Argentina for autologous MSCs and then to Mexico where he got MSCs and neural stem cells. See image above from the talk. The spinal tumor had many weird features of various primitive tumors. It was clearly a malignancy. There were no major cancer-related mutations detected in the OncoPanel assay.
The bottom line. So when those promoting stem cell clinics or wanting much less oversight ask “what can go wrong?” and they don’t really believe much can go wrong, we now know for sure that that view is just not accurate. Intensely bad stem cell clinic outcomes are occurring right here in the U.S. "
Linked in that same article, one of the most prestigious and respected "real science" journals in existence, NATURE:
Thomas Albini met his first patient blinded by a stem-cell ‘treatment’ last year. The elderly woman, who had macular degeneration, thought she was paying to participate in a clinical trial that would save her sight by injecting stem cells into both eyes. Instead, it left her legally blind.
By the time Albini, an ophthalmologist at the University of Miami in Florida, had treated two more women who had been blinded by the same procedure, he knew that there was a systemic problem. Two of the women had been lured by a posting in a clinical-trial registry — even though there was no real trial to speak of — and none of the injections had been administered by a physician. The clinic offering the injections claimed that its procedure did not require approval from the US Food and Drug Administration (FDA), in part because it used the patient’s own cells. Altogether, Albini found the cases shocking. “Any sort of review would have been helpful.”
The debate over whether the FDA should review such treatments is growing more intense as purported stem-cell clinics proliferate across the United States. Current FDA regulations are poorly enforced and leave room for various interpretations. On 8 September, Albini will present his experiences at an FDA workshop. The following week, dozens of researchers, companies and patient advocates will flock to Bethesda, Maryland, for an FDA public hearing. Many of them will tout the virtues of unproven stem-cell therapies and insist that people should have the right to such treatments. The FDA has expanded the one-day hearing to two — and moved it to a larger auditorium — in response to overwhelming public interest.
The discussion will focus on FDA proposals that aim to better define which cell therapies deserve strict regulation. If adopted, these controversial guidelines could encompass a large chunk of the cell-therapy clinics that claim to fall largely outside the agency’s purview.
A burgeoning industry has sprung up in the absence of definitive oversight. A recent study of stem-cell clinics that advertise online uncovered 570 such centres operating in the United States (L. Turner and P. Knoepfler Cell Stem Cell 19, 154–157; 2016).
Under FDA regulations, these clinics must prepare and store their therapies safely, and their facilities are subject to sporadic inspections. But many clinics also operate under the assumption that they do not need the agency’s approval to carry out their procedures and do not have to conduct the clinical trials that the FDA normally demands to prove that a therapy works. Agency regulations state that clinics do not need regulatory approval if therapies involve “minimal manipulation” of cells that do not fundamentally alter their properties, and if those cells fulfil a “homologous” function similar to their original role in the body. But the precise definitions of “minimal manipulation” and “homologous use” are controversial.
A series of four FDA draft guidelines released in 2014 and 2015 addressed that ambiguity by providing concrete examples of what would trigger greater FDA oversight. After soliciting public comment, the FDA will decide whether to amend and finalize the proposals.
Not everyone is happy with the results up to now. Arnold Caplan, who studies regenerative medicine at Case Western Reserve University in Cleveland, Ohio, worries that the FDA will start seeking approvals for treatments that are now considered standard, including the use of abdominal fat in breast reconstruction following a mastectomy.
Others are concerned that tighter guidelines will make it harder to bring discoveries to market. “It will potentially slow down translation in many instances,” says Keith March, a cardiologist at Indiana University in Indianapolis, who will also present at the public hearing. “We need to be cognizant of that.”
Too late? Some researchers are glad that the FDA is tackling the issue, however. Stem-cell researcher Jeanne Loring at the Scripps Research Institute in La Jolla, California, and her lab are talking to the FDA about starting clinical tests of a stem-cell treatment for Parkinson’s disease. “They’re making sure we know what we’re doing,” she says.
But even if the FDA finalizes the proposals, it is unclear what effect the rules will have, says bioethicist Leigh Turner at the University of Minnesota in Minneapolis. The stem-cell clinics are too entrenched to be chased away by FDA guidance, he says. “The real question is if the FDA is going to send inspectors and issue warning letters.”
For Albini, the proposed FDA guidance is not a perfect solution, but it is at least a step in the right direction. He may never know for sure why the treatments blinded his patients. And he acknowledges that clearer guidelines — and stricter enforcement — will not prevent every such tragedy in the future. Neither will they keep some clinics from recruiting patients under the guise of conducting clinical trials. But every step counts. “The more regulatory hurdles you put in the way of somebody who wants to use the term ‘research’ as marketing, the better off we’d be,” Albini says.
Nature 537, 148 (08 September 2016) doi:10.1038/537148a"
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