July 10, 2020

The Niche

Knoepfler lab stem cell blog

Month: July 2012

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

There was a burst of feeling last night in the stem cell community as word began circulating that a federal court had ruled in favor of the FDA defining manipulated stem cell products as drugs. However, not everyone was pleased with the court ruling. The clinics most directly affected by the ruling were understandably upset, but interestingly some long-time stem cell advocates also were worried. They said there are potentially serious downsides to the federal court ruling. What might be the negative repercussions? The …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

2 min read

Remember that game where the slick guy on the street corner (at least in the movies) has three shells and one pea and he shuffles them around….then you are supposed to point to the shell with the pea under it? Sellers of dubious stem cell treatments are playing their own versions of “stem cell shell” and definitely it is not to benefit patients. In the stem cell shell game, the goal is to make money off of patients. One version is where stem cell …Read More