Some American stem cell clinics that operate without FDA approval can give the appearance of being in the mainstream of academic stem cell research. Sometimes they go a step further to hint at or even say that they have some kind of federal approval as we saw in the past with the Stem.md website. Why […]
The FDA mandate to regulate drugs and devices often invokes a term called “interstate commerce”. Like many people I thought I knew what that meant, but probably like most people I was wrong. After a great discussion on an original post on various key issues related to the many stem cell clinics doing non-FDA approved
When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the
Stem cell clinics, FDA, & giant, unapproved for-profit human experiments Read More »
Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of
FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet? Read More »
NBC News did a big on-line story and even a NBC Nightly News Segment on dubious stem cell therapies on Friday. Normally a national news story on the problem of the mushrooming stem cell clinics selling unapproved “treatments” would be a positive development, but this otherwise very nicely done story might have a major error that could confuse millions
Did NBC News Err On Key Part of Their Stem Cell Report? Read More »
The FDA has issued a warning letter to Cell Vitals, a company that manufactures and sells stem cell face creams. Cell Vitals is apparently owned by Irene Hardy according to the letter and the business has an address in Irvine, CA. A screenshot from their website is shown below. The stem cell creams sold by Cell Vitals
FDA warning letter to stem cell face creams maker Read More »
It’s been a seemingly rather quiet year on the FDA regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank
FDA on Key Stem Cell Regulatory Issues & Its Own Research Read More »
The list of stem cell journals seems to grow longer every day. In fact, the list is so long and some of the names kind of funny that it inspires coming up with a slew of satirical and nonsensical stem cell journals. I’m betting that some of these (the ones listed first) may be thought up
The nonsensical list of stem cell journals Read More »
What the heck happened to the FDA when it comes to regulating stem cell clinics? Has it given up? Or does it just seem that way because it moves in slow motion? The FDA might as well have thrown in the towel because, as I like to say, the stem cell field moves in dog years.
Has the FDA given up on regulating stem cell clinics? Read More »
I’ve always got stem cells on the brain. What’s on your mind about stem cells? There’s a ton going on so what specifically has got your attention? What are you thinking about? What has you excited? Depressed? Angry? Hopeful? Headlines from the last few weeks: Nuclear transfer ES cells compared to iPS cells Trounson moves
TGIF stem cells on the brain: what’s on your mind? Read More »