Hundreds of companies across the United States are selling unapproved stem cell treatments directly to patients, raising concerns about safety and scams in a fast-growing industry, researchers said Thursday.
At least 351 companies across the United States are marketing unapproved stem cell procedures at 570 individual clinics, their report in the journal Cell Stem Cell found.
The clinics claimed to offer “stem cell interventions” for muscle and bone disorders, heart disease, problems with the immune system, injured spinal cords, cosmetic reasons and more.
Sixty-one percent of the stem cell procedures marketed involved fat-derived stem cell interventions, and 48 percent offered bone-marrow-based treatments.
Only one company was found advertising embryonic stem cells.
Researchers compiled the list by searching online, saying their results “should serve as a baseline for future studies of US businesses engaged in direct-to-consumer advertising of purported stem cell interventions,” the report said.
“In almost every state now, people can go locally to get stem cell ‘treatments,'” said co-author Paul Knoepfler of the University of California, Davis, and Shriners Hospital For Children.
Clinics advertising stem cell treatments are most common in California (113 clinics), Florida (104), and Texas (71).
“This is a marketplace that is dramatically expanding before our eyes,” said co-author Leigh Turner, a bioethicist at the University of Minnesota.
Such businesses have entered the marketplace routinely since 2009, he said.
“Does that mean that people are getting access to safe and efficacious interventions or is there basically unapproved human experimentation taking place?” he added.
“Brakes ought to exist in a marketplace like this, but where are the brakes? Where are the regulatory bodies? And how did this entire industry come into being in a country where stem cell-based interventions and the medical devices that produce them are supposed to be regulated by the FDA?”
The US Food and Drug Administration (FDA) has approved the use of stem cells for leukemia treatment — commonly known as bone marrow transplants — and some bone, skin and corneal diseases or injuries, according to the International Society for Stem Cell Research.
“Other stem cell treatments, while promising, are still at very early experimental stages,” the society’s website says.
The FDA will hold two meetings on the topic later this year, and “is concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful,” the agency said in a statement.
It (Other OTC: ITGL – news) also urged consumers to “to learn all they can about the regulations covering any stem cell-based product they are considering” and has published a consumer update titled “FDA Warns About Stem Cell Claims.”
“Individuals considering stem cell therapy are urged to ask questions to ensure that the necessary FDA approval has been obtained,” the FDA said.
Thursday’s study did not delve into potential harms caused by unapproved stem cell treatments.
In January, a patient sued a stem cell clinic alleging damage to her eyes from fat stem cell injections in what Knoepfler said may be the first such lawsuit of its kind.
‘He’s empty’: Psychiatrist warns Trump is in a ‘psychotic-like state’
Dr. Lance Dodes warned that things were going to get worse under President Donald Trump in 2017. That's precisely what happened.
"Is that what we're seeing this week?" MSNBC host Lawrence O'Donnell ased the psychiatrist.
"Absolutely. Donald Trump, because he has a fundamental need to be all-powerful and all loved, can't stand challenges," Dr. Dodes said. "And the nature of democracy is that it challenges people. We have more than one opinion. So the more -- it was predictable once he got into a position where people would challenge him, there are two parties, he would become more unhinged.
Elementary school cheer squad parents raffling off an AM-15 automatic weapon as a fundraiser
Just weeks after a mass shooting in Dayton, Ohio killed nine people, only 200 miles away in Richmond, the cheer squad is selling raffle tickets to sell a semi-automatic gun.
Fox19 reported Wednesday that the Junior Lions Cheer Team have infuriated Heather Chilton, who's 7-year-old daughter is on the squad for the first time.
"This is absurd, you're having elementary kids sell your AR-15. Why?" Chilton said. "I highly doubt that something would happen with the gun, but say it did. Say one of the kids in the high school got a hold of it — got the AR-15 or AM-15 and shot up a school with it, and I'm the one that sold the raffle ticket to his dad?"
I think Trump’s people sit around ‘thinking up new ways to be cruel’: Senator
On Wednesday's edition of MSNBC's "All In," Sen. Mazie Hirono (D-HI) tore into the Trump administration for its treatment of migrant children, as yet more reports come in of children being denied basic services in squalid conditions, and as Trump considers ways to get around the federal consent decree placing limits on how long they can be detained.
"We already know from so many child specialists that detaining children in these kinds of facilities does irreparable damage to them," said Hirono. "There are alternatives to family detention this administration could care less about ... the only way to get around the consent agreement is by getting around it by proposing or having this rule, which will be immediately challenged. They want to detain families indefinitely, children indefinitely, held in situations that do them absolutely no good when there are alternatives."