The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs. That would be a good thing for patients who are often being put at risk by many of …
FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces Read More »
Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment …
FDA warning points to tougher regulation of fat stem cells & clinics Read More »
The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) …
FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »
Each year around this time I check up on my past year’s predictions for the stem cell field. For 2015 I made 20 predictions. You can see past 10 predictions lists for 2013 and 2014. It’s pretty interesting to look back at where the focus was in past years and what my crystal ball yielded …
How did my 20 stem cell predictions for 2015 fare? Read More »
Over the years I’ve heard from quite a few patients of stem cell clinics who feel very strongly about their experiences. Some have quite positive views on getting stem cell interventions, while others feel very negatively about the stem cell clinics. I’ve heard more of the latter kind of experience. People often tell me that …
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 »
Each year towards the end of December I make predictions for the coming year as I did for 2015. In the past I usually make a top 10 prediction list, but for this year I made 20 predictions. Admittedly some of them may have been more hopes than predictions. At mid-year today on June 30th, …
How are my 20 stem cell predictions for 2015 doing? Read More »
Stemedica announced it is teaming up with UC San Diego (UCSD) to do stem cell research. This fits with an increasing trend in the stem cell arena is the teaming up of clinical partners with very different backgrounds and priorities. For instance, academic institutions are more often working together with for-profit stem cell clinics. Another branch …
Muddier stem cell waters: Stemedica teams up with UCSD doc? Read More »
Popular Science recently did a piece on stem cell clinics that has raised some red flags. The concerns in this case are not necessarily about the clinics per se, but rather the actual article itself. There are a lot of stem cell clinics out there and for years they had a pretty consistent strategy of …
Popular Science stem cell clinic article itself raising some red flags Read More »
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 …