July 15, 2020

The Niche

Knoepfler lab stem cell blog

FDA

2 min read

Stem cell cosmetics is an exploding area ranging from facial creams (e.g. from L’Oreal and its Lancome) to face lifts to boob jobs to baldness treatments (see two key posts here and here for background and great stories). The stem cell cosmetics field has not been held back by issues such as the fact that there is no science behind their expensive creams and treatments or that they do not have FDA approval. Today the FDA gave the stem cell cosmetics field a wake …Read More

3 min read

Today there is an editorial piece in the WSJ about the recent court ruling giving the FDA authority to regulate stem cells grown in culture as drugs. As a stem cell scientist, I read this opinion piece with interest. Unfortunately it is behind a paywall, but I have outlined and discussed the key issues below. The article is well written, but very biased too. In fact, I think it completely misses the boat. Nonetheless, the article carries some weight because it is written by …Read More

3 min read

Stem cells grown in culture are drugs. Agree or disagree? I believe it is a correct statement. I don’t think it is even a question any more as it was a few months ago. Yes, I am convinced that the FDA, as supported by a recent federal court ruling, has it right that growing stem cells in culture yields biological drugs. Such growth makes stem cells fundamentally different than the endogenous stem cells that exist in our bodies. In fact not just me, but …Read More

2 min read

Are stem cells drugs? At least for today, a federal court unambiguously ruled that the answer to this question for manipulated stem cells is “Yes”.  The story has been reported in the media at New Scientist and Scope Blog. You can read over the key issues here. The court ruled in favor of the federal government and FDA and against Regenerative Sciences, Inc. (RSI), finding that manipulated stem cells are drugs. What does this mean? I believe that the federal court just ruling  has at least temporarily delivered a major blow …Read More