I’m enjoying Celltex’s new website and I’m appreciative of their great responsiveness to my questions. Transparency is a beautiful thing! My latest question to them was whether they, given that the FDA called them a “drug manufacturer”, are now planning to or have already filed an IND. An IND is an application for an investigational …
More Celltex Q&A: we are not a drug manufacturer Read More »
How does Texas stem cell clinic Celltex make their stem cell drug? This is a very key question as the answers will help the stem cell field evaluate this drug’s potential safety and efficacy. I’m calling it a “drug” because the FDA called Celltex a “drug manufacturer” and by all past FDA precedent as well …
My ongoing Q&A with Celltex on their stem cell drug production methods 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 »
Now six years into its existence, the induced pluripotent stem (iPS) cell field is no longer in its infancy to put it mildly but what will it take to get IPS cells to patients? Perhaps one might say that cutting edge new scientific fields advance in dog years. In that way of thinking, the iPS …
Celltex, the controversial stem cell clinic in Texas, announced in a press release (PR) today a couple of new hires. It also fired up its website for the first time that I am aware of. You can check out the website here. Wow. The website is notable since it has been inactive for quite some …
New Celltex website goes live for the first time, making many safety & efficacy claims Read More »
Has there been stem cell doping in the Olympics? Readers of this blog have been asking me this question more than any other in the last week. Part of the impetus for this question is the growing number of professional athletes who more generally have received dubious stem cell treatments in foreign countries, perhaps treatments …
Question of the week: is there stem cell doping in the Olympics? 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 »
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, …
Refuting potential downsides to stem cell drug court ruling Read More »
“I lied to patients,” testified a weeping, young woman in court related to a fraud allegation involving stem cells. She had worked as an office assistant at a company that injected bogus and potentially dangerous cow-based “stem cell” treatments into human patients. This company, which in different incarnations went by various names including Biomark in …
Testimony in supermodel stem cell fraud case: “I lied to patients” Read More »
Does science need some kind of version of a Dr. Oz to tell the world about science in simple, easy-to-understand ways that don’t distort the science? I’ll admit I’m not a fan of Dr. Oz for a number of reasons, but I know he has legions of fans including my mom. One of the reasons …
Dr. Oz vs Carl Sagan: risks & rewards of pop-sci media and writing Read More »