By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    HIPPA compliance
    How Medical Office Staff Can Make Your Practice HIPAA Compliant
    October 29, 2021
    Everything you need to know about hyaluronic acid treatment
    Everything you need to know about hyaluronic acid treatment
    February 10, 2022
    Which Mushroom Capsules Are Good for Your Health?
    May 5, 2022
    Latest News
    6 Easy Healthcare Ways to Sit Less and Move More Every Day
    September 10, 2025
    7 Most Common Healthcare Accreditation Programs: Which Should You Use?
    August 20, 2025
    Hospital Pest Control and the Fight Against Superbugs
    August 20, 2025
    Hygiene Beyond The Clinic: Attention To Overlooked Non-Clinical Spaces
    August 13, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Extending the Frontiers: Working Despite Alzheimer’s and Campus Smoking Bans
    September 1, 2011
    Wall Street Protesters Need a Cause Like Healthcare
    October 6, 2011
    Maps 2.0: Interacting With Our Health Care World
    November 14, 2011
    Latest News
    Healthcare at a Crossroads: Why Leadership Matters More Than Ever
    September 9, 2025
    How Social Security Disability Shapes Access to Care and Everyday Health
    August 22, 2025
    How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
    August 22, 2025
    How One Fall Can Lead to a Long Road of Medical Complications
    August 22, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA Regulation Of Stem cell Medicine
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Policy & Law > FDA Regulation Of Stem cell Medicine
Policy & Law

FDA Regulation Of Stem cell Medicine

BarbaraDuck
BarbaraDuck
Share
5 Min Read
SHARE

Since stem cell research and development is moving so fast, this article brings up a lot of good questions as to how regulation will or will not take place.  As the rules/laws read, culturing stem cells in the eye of the FDA is considered a “drug”.  The article talks about a “tool kit” being in place in a few years at a physician’s office.  Guidelines are being developed by the American Stem Cell Therapy Association for safe use, like fertility clinics where state laws would have jurisdiction.  

Since stem cell research and development is moving so fast, this article brings up a lot of good questions as to how regulation will or will not take place.  As the rules/laws read, culturing stem cells in the eye of the FDA is considered a “drug”.  The article talks about a “tool kit” being in place in a few years at a physician’s office.  Guidelines are being developed by the American Stem Cell Therapy Association for safe use, like fertility clinics where state laws would have jurisdiction.  

Stem cells are taken from the patient and injected back, no cells from outside sources and this kind of reminds me a bit of the Provenge cycle with the anti immune drug with being processed and re-injected so in time we will have entirely new classes of drugs and treatments for a lot less cost potentially.  One remark made here too is the fact that a $60 billion dollar drug and device care system would be in time reduced to a $6 Billion dollar stem cell business and of course there’s not much more that needs to be said there with the number of drug and device companies in business, although not all would go away but the number of devices and drugs that we used today could shrink.  BD 

Within the next five years, it’s quite possible that physicians will come into routine possession of a remarkable set of tools   — a brand new way of dealing with the frailty and disabilities of aging.  The tool kit is autologous stem cells derived from the patients themselves, amplified in culture, and infused back into the patient according to a precise protocol.  It would be such a leap from today’s medical diagnostics and treatments; it could only be called revolutionary.

The purpose of employing autologous cells is to prevent rejection of histo-incompatible cells by the patient’s immune system. But it’s also possible that these new therapies could slip from our grasp, at least in the US. If we’re not careful, these therapies could become the exclusive domain of the pharmaceutical industry, as regulated by the Federal Food and Drug Administration  (FDA). This could push the availability of this tool kit 15 to 20 years into the future. The opportunity-cost in terms of morbidity and mortality could be catastrophic.

We’ve got an organization to formulate guidelines, and we’ve got clinicians working to form a stem-cell registry. But the FDA doesn’t appreciate that. We only do adult cells from the same person. But the FDA contends that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug.” He points out that the age-management community has seen many instances where the FDA has tried to insert itself into the practice of medicine — although this has been strictly prohibited by Congress — and this is just the latest. “Compounding pharmacies have been coming under FDA pressure for a long time, and have now organized and set up their own standards and guidelines as a way to combat that interference.”

“You’re talking about replacing $60 billion in drug– and device-care with $6 billion in stem-cell care,” Dr. Centeno observes.

Will the FDA Kill Adult Stem Cell Medicine? | medical students exam Blog

More Read

Antibiotics’ Scary Future
Ronald Hansen on the NIH’s Planned Drug Development Center (transcript)
NFL Players Hosted Concussion Summit Week Before Super Bowl
Which Medical Specialty Should Medical Students Choose?
Waiting for HIPAA Clarity? Who Has Time?

TAGGED:FDAhealth care policystem cells
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

a woman walking on the hallway
6 Easy Healthcare Ways to Sit Less and Move More Every Day
Health
September 9, 2025
Clinical Expertise
Healthcare at a Crossroads: Why Leadership Matters More Than Ever
Global Healthcare
September 9, 2025
travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025

You Might also Like

How Much Should We Spend on Healthcare ?

May 2, 2012

Giving Interns More Sleep is Not Making Hospitals Safer

August 13, 2011

Massachusetts Governor’s Race: Views on Healthcare

September 9, 2014
medications-cure-tablets-pharmacy-56612.jpeg
Policy & Law

Using Digital Technologies to Solve Pharma’s Cost of Care Crisis

July 9, 2016
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?