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 »
ABC News just reported that the FDA is allgedly “cracking down” on the publicly traded company, MiMedx (MDXG), which sells a placental derivative touted for healing powers. The Wall Street Journal is also following the story. According to ABC News: MiMedx is a publically traded, for-profit company that takes donated human placentas — solicited via a website featuring
MiMedx (MDXG) placental “stem cell magnet” drugs attract FDA attention and lawsuit Read More »
I met with Texas Governor Rick Perry, himself a recipient of stem cell transplants, last year to talk stem cells. He was enthusiastic about stem cells to put it mildly and it was great to talk with him. My impression from meeting with him in person is that he is clearly a very intelligent, energetic,
Rick Perry Sticky Stem Cell Problem for 2016 Read More »
What’s the deal with IntelliCell Biosciences, headed up by Dr. Steven Victor? Sometimes science can move at warp speed and that is even more true of the stem cell field. One stem cell establishment that seems to be in a particularly intense period of activity and that has drawn a great deal of attention lately
Interview with Dr. Steven Victor of IntelliCell Biosciences (SVFC) Read More »