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
JAN 23, 2020
Earth & The Environment
JAN 23, 2020
Scientists Assess the Value of the Ocean's Twilight Zone
Fifteen years ago, an international cohort of scientists and policy experts introduced the idea of assessing ecosystems by the "services" they pr...
JAN 28, 2020
Plants & Animals
JAN 28, 2020
A Slug Does All it Can to Defend Against Hungry Ants
Slugs are slow, and this makes them easy targets for predators however big or small they might be. Here, we see that a slug has been spotted by a hungry co...
MAR 10, 2020
Space & Astronomy
MAR 10, 2020
NASA's OSIRIS-REx Spacecraft Inadvertently Discovered a Black Hole
NASA’s OSIRIS-REx mission, a short and sweet acronym for Origins, Spectral Interpretation, Resource Identification, Security, Regolith Explorer, was...
MAR 15, 2020
Plants & Animals
MAR 15, 2020
The Incredible Life of a Sea Urchin
From start to finish, a sea urchin’s life involves an incredible and lengthy journey. From the moment a wandering sperm meets an egg somewhere in the...
MAR 30, 2020
Space & Astronomy
MAR 30, 2020
If Gravity Has Mass, This Could Explain Dark Energy
The Big Bang purportedly transpired 13.8 billion years ago, and even so, the universe continues to expand even today. But if that thought alone wasn’...
APR 01, 2020
Cardiology
APR 01, 2020
Avoiding Caries in Children
Thankfully, children are free of many of the chronic diseases that plague older populations. That said, one of the most common chronic diseases children do...
Loading Comments...