LOADING ...

Contaminated Stem Cell Treatments Sickened at Least 12 People in 2018

Ed Cara Dec 27, 2018. 0 comments

Public health experts have been warning us about clinics offering unapproved and untested stem cell treatments for some time now. But a recent report from the Centers of Disease Control and Prevention (CDC) underscores the health risks these procedures can have. An outbreak linked to stem cell injections contaminated with bacteria sickened at least 12 people this year, the report found.

According to the report, the first whiff of the outbreak came in September, when Texas health officials learned of three cases in which people got serious infections after receiving a stem cell treatment at an outpatient clinic. That same month, Florida officials reported another four cases from between February and August. Since then, there have been three other cases reported in Texas, along with one in Arizona. Though all of the patients were hospitalized with infections, some for over a month, fortunately no one died.

The infections were all linked to stem cell products distributed by a California company called Liveyon; Liveyon in turn had obtained its products (processed from umbilical cords donated after birth) from the biotech company Genetech. Supplies of unused stem cell products at the affected clinics were found to be contaminated with bacteria including Escherichia coli and Proteus mirabilis, which commonly infect wounds, and similar strains of these bacteria were also found in the sickened patients. So it’s likely the contamination happened before the products ended up at the clinics.

Stem cells are immature cells that can transform into other kinds of cells. They interest scientists who are eager to use them to regrow or heal damaged parts of the body. Currently, though, stem cell products processed from umbilical cords are only approved to help restore a person’s immune system or supply of stem cells, usually following treatments like chemotherapy or bone marrow transplants. But nearly all of the patients who were sickened had received the stem cells for unapproved conditions like nerve pain or joint problems.

In late September, Liveyon issued a voluntary recall of its Genetech-sourced products and announced it would discontinue its use of the products. But that seemingly hasn’t been enough for the Food and Drug Administration. Last week, the agency once again issued a warning to Genetech over the unapproved use and marketing of these products, as well as its lack of good safety practices. It also sent letters to other clinics and companies selling off-label stem cell treatments, reminding them of the regulations surrounding stem cell treatments.

As things stand, companies technically have until November 2020 to file their stem cell products for approval with the FDA, either as a new drug or as a premarket approval, meaning the product would be considered as safe as products already on the market. Until then, the agency has promised to be lenient in how it regulates companies and clinics currently selling off-label stem cell treatments, depending on how these products are used and the risks they might pose to consumers. But Gottlieb warned that the agency would aggressively go after companies and clinics that are getting people sick.

“The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion,” he said in a statement.

Scientists and researchers, meanwhile, have criticized the FDA for its tolerance of these clinics. Several studies have shown that clinics in both the U.S. and elsewhere are frequently claiming to treat everything from Alzheimer’s disease to HIV with the help of stem cells—claims that are not yet supported by strong evidence.

[CDC/FDA]

Other Ed Cara's posts

'Cuban Sonic Attack' Study Finds Brain Differences in Victims—but Don't Put on Your Tinfoil Hat Yet 'Cuban Sonic Attack' Study Finds Brain Differences in Victims—but Don't Put on Your Tinfoil Hat Yet

In late 2016, U.S. diplomats at the American embassy in Havana, Cuba began coming down with unexplained symptoms, including nausea, headaches, and hearing loss. Some also claimed to have heard mysterious sounds just prior to their symptoms, fueling a theory by some U.S. officials and the media that a “sonic weapon” aimed at the diplomats could have been to blame....

Cigarette Butts Stunt Plants' Growth Cigarette Butts Stunt Plants' Growth

Other humans aren’t the only living things affected by your smoking habit, scientists in the UK warn. Their new research suggests that at least some plants can’t grow as well in the presence of discarded cigarette butts.Cigarette butts—the plastic, usually brown filters left behind when you finish smoking—are a ubiquitous source of pollution. By some accounts, they’re the most...

Checking Your Phone at Night Won't Necessarily Throw Off Your Internal Clock, Mouse Study Finds Checking Your Phone at Night Won't Necessarily Throw Off Your Internal Clock, Mouse Study Finds

People who only occasionally fall down an internet rabbit hole on their smartphones late at night might be able to rest easier—at least according to the results of a new study in mice. Researchers found that short bursts of light exposure at night won’t necessarily disrupt your internal clock, including sleep habits.The researchers used mice to study the circadian...

Listening to Music Before Getting Anesthesia Can Help You Stay Calm Listening to Music Before Getting Anesthesia Can Help You Stay Calm

A dose of music might be enough to calm your worries before certain medical procedures. According to a new study out this week, patients who listened to music before having anesthesia injected into them had their level of anxiety lowered as much as those who took a mild sedative.Doctors have gradually started to turn to the power of music...

Suggested posts

Mysterious Glass Beads in Clams Point to Ancient Meteorite Strike Near Florida Mysterious Glass Beads in Clams Point to Ancient Meteorite Strike Near Florida

Since their discovery 13 years ago, scientists have puzzled over the origin of tiny glass beads found inside ancient clam shells. New evidence suggests they’re microtektites—a byproduct of meteorite impacts—marking the first time these celestial remnants have been found hiding in old clam shells.Ancient clam shells uncovered at a Sarasota County quarry in Florida are the unexpected repositories of...

Scientists Think They Know Why So Many Meteorites Look Like Cones Scientists Think They Know Why So Many Meteorites Look Like Cones

You might think of meteors as flashes in the sky that result in lumpy-looking meteorites on the ground. But not all meteorites are lumps. A substantial population, like the leftovers from the 2013 Chelyabinsk airburst , are notably conical. One team of scientists thinks they know why. A group of New York University researchers study how things on Earth...

'Cuban Sonic Attack' Study Finds Brain Differences in Victims—but Don't Put on Your Tinfoil Hat Yet 'Cuban Sonic Attack' Study Finds Brain Differences in Victims—but Don't Put on Your Tinfoil Hat Yet

In late 2016, U.S. diplomats at the American embassy in Havana, Cuba began coming down with unexplained symptoms, including nausea, headaches, and hearing loss. Some also claimed to have heard mysterious sounds just prior to their symptoms, fueling a theory by some U.S. officials and the media that a “sonic weapon” aimed at the diplomats could have been to blame....

Authorities Upset That 'Soho Grifter' Anna Delvey Could Be Getting a Big Payday From Netflix Authorities Upset That 'Soho Grifter' Anna Delvey Could Be Getting a Big Payday From Netflix

Anna Sorokin—the woman who posed as a German heiress and swindled New York’s social elite and numerous institutions out of hundreds of thousands of dollars under the name Anna Delvey—may not be able to cash in on the forthcoming Netflix series based on her story.The New York Post on Sunday reported that the office of the New York State...

Historic Indian Moon Mission Underway After Successful Launch of Chandrayaan-2 Lander and Rover Historic Indian Moon Mission Underway After Successful Launch of Chandrayaan-2 Lander and Rover

The Chandrayaan-2 mission is officially off to a promising start, as India vies to become the fourth nation to land on the Moon.The Indian Space Research Organization (ISRO) launched the three-stage GSLV Mk-III rocket on Monday, July 22 at 2:43 p.m. local time from the Satish Dhawan Space Centre at Sriharikota, an island off the coast of Andhra Pradesh,...

U.S. Beaches Are So Full of Sewage Pollution, They're Often Unsafe for Swimming, New Report Finds U.S. Beaches Are So Full of Sewage Pollution, They're Often Unsafe for Swimming, New Report Finds

I don’t go to the beach for the sand or the sun. I go for the waves. There’s nothing like splashing in the water after lugging your cooler, chair, and beach umbrella to your designated spot. Unfortunately, I may need to think twice about going for a swim at the beach. And so should you. A new report out...

Libra Scammers Are Promising Early Access to Facebook's Digital Currency to Steal Private Information Libra Scammers Are Promising Early Access to Facebook's Digital Currency to Steal Private Information

Your browser does not support HTML5 video tag.Click here to view original GIFOne scam video that appears on YouTube and coaxes people to hand over personal information to get “early access” to Facebook’s Libra digital currencyGIF: YouTubeIf you search YouTube for Facebook’s Libra, you’ll find plenty of videos that tell you how to buy the digital currency. The problem is...

Cigarette Butts Stunt Plants' Growth Cigarette Butts Stunt Plants' Growth

Other humans aren’t the only living things affected by your smoking habit, scientists in the UK warn. Their new research suggests that at least some plants can’t grow as well in the presence of discarded cigarette butts.Cigarette butts—the plastic, usually brown filters left behind when you finish smoking—are a ubiquitous source of pollution. By some accounts, they’re the most...

Checking Your Phone at Night Won't Necessarily Throw Off Your Internal Clock, Mouse Study Finds Checking Your Phone at Night Won't Necessarily Throw Off Your Internal Clock, Mouse Study Finds

People who only occasionally fall down an internet rabbit hole on their smartphones late at night might be able to rest easier—at least according to the results of a new study in mice. Researchers found that short bursts of light exposure at night won’t necessarily disrupt your internal clock, including sleep habits.The researchers used mice to study the circadian...

Jupiter's Volcanic Moon Io Continues to Surprise Scientists Jupiter's Volcanic Moon Io Continues to Surprise Scientists

Scientists have published five years of observations of Jupiter’s volcanic moon Io, revealing just how strange the world is. They even describe one volcano that might be influenced by the moon’s orbit. Io is Jupiter’s fourth-largest moon and the most volcanically active object in the solar system. The five years of infrared observations go against scientists’ models of the...

Language