FDA to consider clamping down on stem cell clinics: 5 takeaways

Spinal Tech

The FDA will conduct hearings next month to determine if the agency will more closely regulate the treatments stem cell clinics offer, according to The Wall Street Journal.

Here are five takeaways:

 

1. Those opposing these clinics are imploring the FDA to impose stricter regulators, while many clinic managers argue they are practicing medicine and the agency doesn't need to give approval.

 

2. The FDA has mainly approved stem cells for blood diseases as many scientists argue more research needs to be done to fully understand how stem cells work and whether they are safe and effective.

 

3. Some argue clinics are making huge promises to patients, raising ethical concerns. Paula Grisanti, DMD, chairwoman of the National Stem Cell Foundation, told WSJ, "Clinics that make over-the-top claims that a single stem-cell therapy will cure ALS or Parkinson's or other diseases raise huge safety and ethical concerns. It gives the whole field a black eye."

 

4. Clinic operators claim their treatments are "patient-funded research," and the prices are miniscule compared to the potential benefits.

 

5. As per FDA regulations, clinics do not need the agency's approval if the stem cells are derived from a patient's own cells, if the cells are not altered significantly or if "they perform their original role in the target location."

 

More device news:
Aurora Spine continues to uptrend; 130k shares traded on Aug. 29 — 5 things to know
Intralink-Spine reports further positive Réjuve clinical results for chronic low back pain: 5 observations
Global wearable health sensors market to hit $48.6M by 2018: 4 observations

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Podcast

Featured Whitepapers