It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains that the feds will prevail, but it seems worthwhile to look at some of US Stem Cell’s arguments. Note as a sort of disclaimer that I’m not an attorney …Read More
adipose stem cells
The cost of stem cell treatments is a big deal for many reasons including the burden it puts on patients, who often then turn to friends, family and even the Internet to try to obtain the money needed to pay the for-profit clinic. A reasonable question to ask is how the cost of a stem cell treatment compares to the costs of more standard of care options. Most often clinic stem cell offerings are more expensive, but not always. However, “value” is another consideration …Read More
Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx very strongly and publicly criticizing a firm called Stem Cell Institute of America. Centeno is vocal on his Regenexx blog about stem cell-related various issues. He is outspoken in …Read More
The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning letter and in an accompanying press release (PR) that ATCELL™ is not minimally manipulated and that its administration did not qualify as homologous use. For these reasons, the letter …Read More
How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results? I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing. In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their own marketing. In the last 1-2 years we’ve seen increasing numbers of mainstream media ads for clinics too (see here and here, for example) so the clinics are thinking …Read More
The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such as in this piece in the WSJ. There he made a number of assertions that signal his view at least back then that when it comes to regulation of stem …Read More
My colleague Leigh Turner and I today published a new paper in Cell Stem Cell documenting for the first time the American stem cell clinic arena in a comprehensive way, which we found as of February has a remarkable 570 clinic locations via 351 businesses. These numbers are way beyond the predictions of most researchers and policy makers for stem cell clinics in the U.S., and point to a burgeoning, huge industry from coast to coast (see map below of clinic locations that we …Read More
Jill Howlin’s drawings about science and policy have a unique, edgy style that packs a punch. I have invited her to weigh in here now and then with new illustrations that touch upon stem cell or other innovative biomedical matters. Jill’s new drawing today relates to some key stem cell issues such as clinical safety, choice of stem cells, homologous use, and more. You can read my post from this week on the myth that stem cells are homologous to all tissues. Jill tells me that she put an Irish humour …Read More
Stem cell biotech company Bioheart ($BHRT) has had a rough 2015 so far. Could this year be a decisive, negative tipping point for the company? It has a number of clinical trials going, but from my view things seem increasingly uncertain. An oddity amongst stem cell biotechs, Bioheart and its leadership have at times seemed to toy with what some might view as controversial projects. Kristin Comella, CSO of Bioheart, has played a major role in other ventures including in the past with the Ageless Institute, a stem …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 cell methods offered by the company US Stem Cell Training. Can you update us on how Bioheart is doing with its clinical trials/INDs? Comella: Our completed clinical trials of …Read More