September 28, 2020

The Niche

Knoepfler lab stem cell blog

FDA Warning

6 min read

Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do about the hundreds of clinics currently marketing them without approval? If not, then how does the agency reconcile that with its past statements and even words this year under …Read More

2 min read

Did Celltex just get an FDA warning letter? I’m not sure. We may find out tomorrow as the FDA updates their public warning letter list early in the week. What’s Celltex? Celltex is that famous stem cell company in Sugarland, Texas that gave Guv Rick Perry stem cell transplants. It was inspected by the FDA in April. The FDA found numerous issues with Celltex and called the company a “drug manufacturer”. In the interim, Celltex has responded to the FDA publicly and privately in …Read More