A couple of months back, the FDA issued a warning letter to three co-owned stem cell clinics selling fat stem cell-based interventions to patients for a variety of ills. You can read all about the warning letter here. It went to lead clinic, Irvine Stem Cell Treatment Center as well as the two co-owned clinics, which […]
Content Wiped on Websites of Stem Cell Clinics Warned by FDA Read More »
The FDA has delayed the planned big April public meeting on stem cells until later this year. Basically, the reason given is that more time is needed for stakeholders to comment. It will be interesting to see if the FDA expands the meeting beyond the 1-day format, which was going to allow each speaker only
Breaking: FDA postpones big stem cell public meeting Read More »
For years I have been working to educate the community about the predatory stem cell clinics out there. These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool. A weapon. As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients
Predatory stem cell clinics are winning: what can we do? Read More »
I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem
Interview with Bioheart CSO, Kristin Comella including on FDA Read More »
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 »
The Texas stem cell clinic Celltex was one of the most controversial businesses in the world of stem cells in 2012 and 2013 (see here for background and as an update see this new post on how the Texas clinic has teamed up with a local university). The FDA essentially shut down the Celltex clinical
Arthritis Foundation Sell Out To Stem Cell Clinic Celltex? 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 »
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 »
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 »
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 »