DEC 27, 2018 4:13 PM PST

Unapproved Stem Cell Treatments Sickened Over a Dozen People Last Year

WRITTEN BY: Carmen Leitch

The Centers for Disease Control and Prevention (CDC) found that at least a dozen people were sickened last year by unapproved stem cell treatments. Three of those patients were subjected to procedures with reagents made by Genetech, Inc. That company and others have been warned by the Food and Drug Administration (FDA) to correct the violations they have been notified about, and that failure to do so may result in “seizure or injunction.”

“The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies. At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” said FDA Commissioner Scott Gottlieb, M.D. in a statement.

“We remain committed to supporting the development of safe and effective cell-based regenerative medicine and advancing our comprehensive regenerative medicine policy framework. These efforts include our work to encourage manufacturers to engage with the FDA early so that we can provide guidance about any applicable regulatory requirements. Even though a few sponsors have come to us, we are discouraged by the overall lack of manufacturers wanting to interact with the agency in this enforcement discretion period. 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. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”

Sources: CDC, FDA

About the Author
  • Experienced research scientist and technical expert with authorships on 28 peer-reviewed publications, traveler to over 60 countries, published photographer and internationally-exhibited painter, volunteer trained in disaster-response, CPR and DV counseling.
You May Also Like
MAY 03, 2020
Plants & Animals
Some Snakes Only Use Venomous Bites as a Last Resort
MAY 03, 2020
Some Snakes Only Use Venomous Bites as a Last Resort
Snakes have a bad rap with people because so many species are known to bite when disturbed. An even smaller subset of sn ...
MAY 17, 2020
Plants & Animals
Male Garter Snakes Trick Others to Improve Own Mating Success
MAY 17, 2020
Male Garter Snakes Trick Others to Improve Own Mating Success
After spending several months in hibernation during the winter, male garter snakes emerge from the underground where the ...
JUN 09, 2020
Space & Astronomy
Why SpaceX's Droneship Footage Often Cuts Out During Landings
JUN 09, 2020
Why SpaceX's Droneship Footage Often Cuts Out During Landings
SpaceX has nearly mastered the art of landing the first stages of the plethora of rockets its sends into space so that t ...
JUL 16, 2020
Chemistry & Physics
Turbulence: A Treat for Both Eyes and Minds
JUL 16, 2020
Turbulence: A Treat for Both Eyes and Minds
What do the air inside your lung, the tap water in pipes, the Great Red Spot of Jupiter, and the hurricane over the Atla ...
JUL 19, 2020
Drug Discovery & Development
Study Finds Turmeric has Antiviral Effects
JUL 19, 2020
Study Finds Turmeric has Antiviral Effects
Researchers from the Wuhan University of Engineering in China have found that curcumin, a natural compound found in turm ...
JUL 27, 2020
Plants & Animals
Ghost Crabs Produce Sounds in Stomachs
JUL 27, 2020
Ghost Crabs Produce Sounds in Stomachs
Research from Scripps Institution of Oceanography (SIO) at the University of California San Diego (UCSD) and University ...
Loading Comments...