June 4, 2020

The Niche

Knoepfler lab stem cell blog

Goldwater Institute

3 min read

The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally going to be a drug product requiring premarket approval. You can see my first quick take on these federal suits here as well as initial responses to the suits …Read More

4 min read

What happens if we mix stem cells with populism? From a populist view of stem cells, everyday patients should be able to do nearly anything they want with stem cells without any governmental interference or excessive expense. Even stem cells not proven to be safe or effective. This can sound like an appealing idea to patients looking for hope and also to some companies looking for profits. Stem cell populism poses serious questions and risks too. What exactly is “populism”? The Internet defines it …Read More

2 min read

Should patients have the Right To Try experimental therapies that could be unsafe and ineffective? What if those patients have a terminal illness and no reasonable prospects of being helpful to conventional medicine? Doesn’t it make perfect sense to let them try a risky approach if they want to do so? On the other hand, could some businesses capitalize on Right-To-Try to try to make a lot of money off of vulnerable patients? Right-To-Try sparks many tough questions like these and there is often …Read More