For years I’ve been writing about fat stem cell clinics that sell non-FDA approved stem cell “treatments” to vulnerable patients right here in America. These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in […]
My new ‘neighbor’ in Sacramento: a fat stem cell clinic 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 »
With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem
FDA Draft Guidance Views Fat Stem Cells As Drugs Read More »
A hot topic in biomedical sciences is converting white “bad” fat into brown “good” fat. The latter type of adipose is viewed more positively because it seems to be associated with a relatively metabolically more active, leaner state. Could we somehow convert white adipose to brown adipose and in so doing have a beneficial effect
Harvard Predicts Fat Burning Stem Cell Pill To Replace Exercise Read More »
Remember the Texas stem cell clinic Celltex, most famous for treating Texas Governor Rick Perry? Celltex had a busy few years, but has been relatively under the radar for most of 2013. Does that mean it’s gone? Hardly. Their saga became more serious when the FDA sent it a warning letter that was predicted by this
Saga of Texas Stem Cell Clinic Celltex Continues Read More »
A big, fat elephant in “the room” of the commercial stem cell field today is something called stromal vascular fraction or SVF, made from human fat tissue or adipose. If you care at all about stem cells or the stem cell field more generally, you had better educate yourself on SVF. You can learn a
Law and Order SVF: what is stromal vascular fraction? Read More »
IntelliCell BioSciences has had a terrible year. Well, there’s terrible and then there’s terrible! Things seem to be getting worse. For background, I detailed its troubles, ups, and downs here in a previous post. I was just working on a new draft post on the most recent, concerning FDA 483 report on the company, which I
IntelliCell Foreclosure Sale Read More »
What does homologous use mean? Navigating the arena of clinical use of a biologic such as stem cells or differentiated cells made from stem cells can be challenging. There are many important issues including what defines “minimal manipulation” of biologics such as cells. One particular issue that is critically important and has drawn less attention
Time to bone up on homologous use in the stem cell field Read More »
Did Celltex just get an FDA warning letter? I’m not sure. We may find out tomorrow as the FDA updates their public warning letter list early in the week. What’s Celltex? Celltex is that famous stem cell company in Sugarland, Texas that gave Guv Rick Perry stem cell transplants. It was inspected by the FDA
Did Celltex just get an FDA warning letter? Read More »
I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below: Dear Dr. Knoepfler, Thank you for your interest
Celltex unsure if FDA agrees product isn’t a drug, but expects 2nd FDA visit soon Read More »