Design World

  • Home
  • Technologies
    • ELECTRONICS • ELECTRICAL
    • Fastening • joining
    • FLUID POWER
    • LINEAR MOTION
    • MOTION CONTROL
    • SENSORS
    • TEST & MEASUREMENT
    • Factory automation
    • Warehouse automation
    • DIGITAL TRANSFORMATION
  • Learn
    • Tech Toolboxes
    • Learning center
    • eBooks • Tech Tips
    • Podcasts
    • Videos
    • Webinars • general engineering
    • Webinars • Automated warehousing
    • Voices
  • LEAP Awards
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Design Guides
  • Resources
    • Subscribe
    • 3D Cad Models
      • PARTsolutions
      • TraceParts
    • Digital Issues
      • Design World
      • EE World
    • Engineering diversity
    • Trends
  • Supplier Listings
  • Advertise
  • Subscribe

FDA Takes A Stand Against Shady Stem Cell Therapy Clinics

By Daniel Seeger | August 30, 2017

Stem cell therapy clinics have been described as a “Wild West” in U.S. healthcare, but the FDA is coming forward to remind those tinkering in the field that there is in fact a sheriff in town.

On Monday, the agency announced stepped up efforts to shut down facilities and companies peddling stem cell therapies that haven’t been cleared through the normal rigorous processes.

“The F.D.A. will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” said Scott Gottlieb, MD, the FDA commissioner, in a statement by released the agency.

The announcement follows regulatory actions taken against a pair of stem cell clinics last week.

The Marshals Service raided StemImmune Inc., located in San Diego, seizing several vials of live vaccinia virus. Typically reserved for individuals at high risk of smallpox, the vaccine was being administered to treat cancer patients.    

U.S Stem Cell Clinic, located in Sunrise, Florida, was sent a warning letter by the FDA. Addressed to Kristin Comella, PhD, the company’s chief scientific officer, the letter detailed alleged shortcomings in quality control and sanitary conditions and further accused the company of barring inspectors from entry. U.S. Stem Cell Clinic denied the charges.

U.S. Stem Cell Clinic made the news earlier this year when three patients claimed they were made blind by a procedure at the facility.

(Image credit: Associated Press/Paul Sancya)

Gottlieb stresses that the crackdown isn’t against the whole field of stem cell research, noting that the “unscrupulous actors” impede the efforts of legitimate healthcare professionals.

“Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science,” insisted Gottlieb.

While some decried the FDA actions as heavy-handed government control of the marketplace, many more hailed it as valuable protection for the field of stem cell therapy as it increasingly moves from research to marketable procedures and devices.

“I see this is a major, positive step by the FDA,” Paul Knoepfler, a University of California, Davis professor of cell biology, told NPR. “I’m hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell ‘treatments’ that may not be real treatments.”

You Might Also Like


Filed Under: Industry regulations + certifications

 

LEARNING CENTER

Design World Learning Center
“dw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest info on technologies, tools and strategies for Design Engineering Professionals.
Motor University

Design World Digital Edition

cover

Browse the most current issue of Design World and back issues in an easy to use high quality format. Clip, share and download with the leading design engineering magazine today.

EDABoard the Forum for Electronics

Top global problem solving EE forum covering Microcontrollers, DSP, Networking, Analog and Digital Design, RF, Power Electronics, PCB Routing and much more

EDABoard: Forum for electronics

Sponsored Content

  • Sustainability, Innovation and Safety, Central to Our Approach
  • Why off-highway is the sweet spot for AC electrification technology
  • Looking to 2025: Past Success Guides Future Achievements
  • North American Companies Seek Stronger Ties with Italian OEMs
  • Adapt and Evolve
  • Sustainable Practices for a Sustainable World
View More >>
Engineering Exchange

The Engineering Exchange is a global educational networking community for engineers.

Connect, share, and learn today »

Design World
  • About us
  • Contact
  • Manage your Design World Subscription
  • Subscribe
  • Design World Digital Network
  • Control Engineering
  • Consulting-Specifying Engineer
  • Plant Engineering
  • Engineering White Papers
  • Leap Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Design World

  • Home
  • Technologies
    • ELECTRONICS • ELECTRICAL
    • Fastening • joining
    • FLUID POWER
    • LINEAR MOTION
    • MOTION CONTROL
    • SENSORS
    • TEST & MEASUREMENT
    • Factory automation
    • Warehouse automation
    • DIGITAL TRANSFORMATION
  • Learn
    • Tech Toolboxes
    • Learning center
    • eBooks • Tech Tips
    • Podcasts
    • Videos
    • Webinars • general engineering
    • Webinars • Automated warehousing
    • Voices
  • LEAP Awards
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Design Guides
  • Resources
    • Subscribe
    • 3D Cad Models
      • PARTsolutions
      • TraceParts
    • Digital Issues
      • Design World
      • EE World
    • Engineering diversity
    • Trends
  • Supplier Listings
  • Advertise
  • Subscribe
We use cookies to personalize content and ads, to provide social media features, and to analyze our traffic. We share information about your use of our site with our social media, advertising, and analytics partners who may combine it with other information you’ve provided to them or that they’ve collected from your use of their services. You consent to our cookies if you continue to use this website.OkNoRead more