U.S. Stem Cell Clinic is in the spotlight after three patients reportedly lost their eyesight following procedures here.
The Sunrise facility offers stem cell treatments for a range of diseases and chronic disorders and yet it has no medical facility license.
Heres what you might not know: It doesnt need one.
The facility falls under a regulatory loophole. Regulators with Floridas Agency for Health Care Administration, which licenses health care facilities like hospitals and rehabilitation clinics, say they have no authority over stem cell operations. Neither does the Florida Department of Health, which only has regulatory power over personnel like licensed doctors and nurses working in these facilities.
Both state agencies say that authority lies with the U.S. Food and Drug Administration. Yet even here, guidelines for adipose stem cells (harvested from the clients themselves) are unclear.
The FDA could not discuss whether U.S. Stem Cell has faced or could face a potential investigation, spokeswoman Andrea Fischer said. She said the agency is working on guidelines that will clarify how human cells, tissues and products based on them should be regulated. The agency also been posting consumer warnings for years alerting patients to ask if theyre going to be part of an FDA-regulated clinical study.
We really dont know what standards these [clinics] have to conform to, said Dr. Thomas Albini, an associate professor of clinical ophthalmology at the University of Miamis Bascom Palmer Eye Institute. He recently co-authored a report in the New England Journal of Medicine about the U.S. Stem Cell cases.
If someone were licensed, that license would be on the line, he said.
There were no sanctions against the private, for-profit clinic after three women, in their 70s and 80s, lost their sight in 2015 following procedures where they had fat cells liposuctioned out of their belly area and injected into both of their eyes. The women had macular degeneration, a common disorder which eventually leads to blindness. They each paid $5,000 for the procedure.
Two traveled from out of state, and one came from Floridas west coast. At least two went to U.S. Stem Cell because of clinical trials listed on clinicaltrials.gov, a database managed by the National Institutes of Health, said Albini, who along with a Bascom Palmer colleague treated two of the patients shortly after their clinic visits. Their complications included detached retinas, optic nerve damage and eye hemorrhages.
The clinicaltrials.gov posting now says the study was withdrawn prior to enrollment.
On its website, the Sunrise facility says its team of medical researchers and practitioners can draw stem cells from their clients own fat tissue and reinject them into their bodies. There, the cells regenerative power can beat back medical disorders like Parkinsons, congestive heart failure and rheumatoid arthritis, according to the company.
In a written statement, the company, originally called Bioheart, said neither the clinic nor its affiliate, U.S. Stem Cell Inc., is currently treating eye patients.
Since 2001, our clinics have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported, the statement said. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations.
The company declined to produce published papers about its research or any trials it had conducted.
Albini questions whether a true trial ever existed. Typically, participants of a clinical trial dont pay for treatment and continue to be monitored through followup appointments. Neither was the case for the three women who went to U.S. Stem Cell Clinic, Albini said.
He also said no legitimate researcher would do an experimental procedure, with no clinical track record, on both of a patients eyes, risking blindness. These people were way out of their league, he said.
Two of the women sued for negligence, failure to warn, and allegations regarding how the product manufactured from their own bodies was defective. Both settled, and their cases were dismissed. Attorneys for U.S. Stem Cell argued that the cases, as filed, involved medical negligence and, as such, needed to be refiled to conform with state law, according to court records.
Attorney Benjamin Bedard, who handled both dismissal filings, could not be reached for comment.
Albini said the FDA had him speak at a workshop in September regarding its concerns about experimental, unlicensed stem cell clinics.
My understanding is its a billion-dollar industry already, he said. We dont have great treatments for people with these conditions. There are people who want tomorrows medicines today and are willing to pay for it.
Staff researcher Barbara Hijek contributed to this report.
dlade@sunsentinel.com or 954-356-4295
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Sunrise stem cell clinic behind blindness cases is largely unregulated - Sun Sentinel