January 16, 2021

The Niche

Trusted stem cell blog & resources

Are stem cells drugs?

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

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

4 min read

Are stem cells a drug? Should the FDA regulate them? Technically, the FDA calls stem cells “biologics”, but the FDA regulates stem cell products with the goal of ensuring safety and efficacy much the same as traditionally define chemical “drugs”. You can learn more about the FDA’s view of and concerns about stem cells here and here. Some for-profit proponents of stem cell-based therapies want the FDA to stop regulating stem cell-based therapies. An example of such a company is CellTex, but there are others. The …Read More