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
BS
Experienced research scientist and technical expert with authorships on over 30 peer-reviewed publications, traveler to over 70 countries, published photographer and internationally-exhibited painter, volunteer trained in disaster-response, CPR and DV counseling.
You May Also Like
NOV 12, 2020
Health & Medicine
Measles Cases and Deaths Surge Worldwide
NOV 12, 2020
Measles Cases and Deaths Surge Worldwide
Today, the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) released a stat ...
JAN 08, 2021
Neuroscience
Brain Scans Show Why Comedy-News Shows are More Memorable
JAN 08, 2021
Brain Scans Show Why Comedy-News Shows are More Memorable
Comedy-news shows such as those by Trevor Noah, John Oliver, and Samantha Bee on the rise and are especially popular amo ...
MAR 09, 2021
Plants & Animals
Sea Slug Shows Extreme Case of Regeneration
MAR 09, 2021
Sea Slug Shows Extreme Case of Regeneration
Some of the most interesting—and possibly strangest—scientific discoveries happen by accident. According to ...
APR 01, 2021
Space & Astronomy
Astronomers Detect X-rays from Uranus for First Time
APR 01, 2021
Astronomers Detect X-rays from Uranus for First Time
Until now, astronomers had detected X-rays from every planet in our solar system apart from the two Ice Giants: Uranus a ...
JUN 05, 2021
Cannabis Sciences
Washington State University Opens Cannabis Research Center
JUN 05, 2021
Washington State University Opens Cannabis Research Center
Washington State University (WSU) has announced the opening of a multi-disciplinary research center with nearly 100 scie ...
JUN 22, 2021
Cannabis Sciences
Report Finds Most First-Time Cannabis Users are Women
JUN 22, 2021
Report Finds Most First-Time Cannabis Users are Women
Chicago-based cannabidiol (CBD) and cannabis-focused market research organization, Brightfield Group, has published a ne ...
Loading Comments...