A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed letters from Celltex to the FDA that previously were not in the public domain. The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I …
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 …
Nordstrom hawking super expensive, non-FDA approved stem cell cosmetic drugs Read More »
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. …
WSJ editorial on issue of stem cells as drugs misses the boat Read More »
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 …
2 decades as cell biologist tell me grown stem cells are drugs Read More »
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 …
Court empowers FDA to regulate stem cells as drugs Read More »
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. …
This post is focused on the important facts you need to know about stem cells as drugs. Many of the folks out there who want to earn a living to scamming vulnerable patients with so-called “stem cell treatments” have been upset that the U.S. FDA continues to view stem cell-based therapies and indeed cell therapies …
Stem cell treatments, drugs, and the key facts you need to know Read More »
I wrote a few weeks ago about a firm called RGCC or Research Genetic Cancer Center, which sells what I see as an unproven RNA therapy to clinics throughout the US. The approach is called supportive oligonucleotide therapy or SOT. After buying it from RGCC, the clinics then sell SOT injections for Lyme disease, other …
US clinics selling unproven RGCC cell therapies in addition to SOT Read More »
A few dozen clinics in the US sell an unproven RNA therapy called supportive oligonucleotide therapy or SOT. The product comes from a Greek firm RGCC or Research Genetic Cancer Center, which also pre-tests patients’ gene expression to design the RNA product. Clinics marketing SOT in the US say it is intended to act by …
Anti-aging might already be the big regenerative medicine story of 2024 and it’s only early March. Anti-aging hype going to the dogs? One of my 20 stem cell and regenerative medicine predictions for 2024 was that longevity would continue to make big news including in some not-so-great ways. In just over two months there has …