Search Results for: warning letter

Leigh Turner Reports Company Precision StemCell To FDA

What is up with the stem cell company, Precision StemCell, these days? I can’t imagine they are exactly celebrating after having been reported to the FDA. They also have apparently moved operations from the US to Colombia at some point recently. What’s the deal here? First, a little background is helpful. In 2012, University of

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Stem cell company Intellicell facing new financial wrinkles

Intellicell

It’s difficult to make it as a biotech company, I would say stem cell biotechs in general may have an even rougher time, and one such company,  Intellicell (Intellicell Biosciences, Inc), is showing a number of signs of distress in my opinion. An online financial tool predicts the probability of companies going bankrupt within the next

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Dr. Steven Victor of Intellicell Comments on its Stem Cell Treatments

Steven-Victor-250x3001

Dr. Steven Victor, CEO of Intellicell, seems to have made two comments on a recent blog post I did on stem cell sports medicine (see below). Victor and Intellicell received a warning letter from the FDA in March 2012 with the FDA. I’m not aware of Intellicell publicly addressing the FDA issues. If you have, Intellicell, please

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What was the strangest event for stem cells in 2012? Pick from top 5 in poll

Every year around this time I put my “best of” the year in stem cells including awards such as my Stem Cell Person of the Year Award. For example here are the 2011 awards. This year I’m also trying with difficult to decide on what was the craziest thing for stem cells that happened in

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Celltex response to FDA says transplants stopped: what are the other key points?

The Houston Chronicle has posted the response letter from Celltex to the FDA in regard to the FDA Warning Letter issued to Celltex. The Chronicle also has a piece up on the warning letter that is a great read here. My thoughts on the possible paths for Celltex moving forward can be found here. The

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As stem cell industry explodes, can a static FDA keep up?

There are legitimate arguments about the degree to which the FDA should regulate stem cell clinics and the point-of-care, for-profit stem cell industry. I’ve held debates about that on my blog with argument on both sides including a very valuable debate between Dr. Chris Centeno and Doug Sipp. However, increasingly it is looking like the

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Nordstrom hawking super expensive, non-FDA approved stem cell cosmetic drugs

What’s the deal with Nordstrom and stem cells? Are they going to rename themselves “Nordstem”? I grew up in Bellevue, WA, home of the Nordstrom’s family and of the Nordstrom department store chain. I believe the flagship store was just across Lake Washington in Seattle. I don’t like shopping as perhaps most guys feel, but

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