August 8, 2020

The Niche

Knoepfler lab stem cell blog

Kristin Comella

3 min read

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with …Read More

4 min read

Is there a proliferating stem cell fake news problem in the biotech world? More broadly, the SEC is cracking down on the mess that is fake biotech news, but what about fake news on stem cell biotechs more specifically? Already in the past year I’ve seen examples of possible stem cell fake news. Hyped press releases (PR) that might arguably be in part fake news are nothing new and there has always been stock pumping, but another more recent phenomenon consists of more extensive series of …Read More

4 min read

Do 3 blinded stem cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image from a new NEJM paper reporting the severe adverse outcomes. The red areas are hemorrhaging with other substantial damage to the retina as well. How did this all happen? Last year the …Read More

6 min read

Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients. What are the concerns? Earlier this year a publicly-traded stem cell business in Florida called U.S. Stem Cell, Inc. was sued along with other defendants by a former customer Elizabeth Noble, alleging harm done via an experimental stem cell “treatment” …Read More