September 19, 2020

The Niche

Knoepfler lab stem cell blog

US Stem Cell Inc.

6 min read

What if it seemed based on the public statements of its leader that a business was using an unapproved and unproven, genetically-modified, stem cell-based ‘cancer vaccine’ on patients? Is that possible? Sometimes I think I’ve seen and heard it all when it comes to companies marketing non-FDA approved, scientifically unproven stem cell ‘therapies’ to patients after 8+ years blogging here, but then I run across something new each year that still surprises me. For example, in a mind-blowing video that the company posted on Facebook the leader of …Read More

3 min read

Three recent media pieces on unproven, for-profit stem cell clinics paint an unflattering picture of this industry. At the intersection of these pieces is the clinic “treatment” consisting of fat stem cells (being manufactured as in a screenshot at right from a clinic YouTube video), a product the FDA has indicated is most often going to be a biological drug requiring pre-market approval, which the clinics generally do not have. The newest newspaper article comes from The Washington Post. Laura McGinley and William Wan take …Read More

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

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