Dr. Richard Burt of Northwestern University has been doing cutting edge research on the use of stem cells for autoimmune disorders for more than a decade. The core idea behind the work that Burt and other research teams are doing is that stem cells may have revolutionary potential to somehow counteract the autoimmunity that causes […]
Burt Northwestern Stem Cell MS Trial Part 1: Big Promise & Tough Questions Read More »
Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false? Do such clinics not bear any legal requirement to provide informed consent to patients? A new court ruling raises such striking questions. San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem
Narrowed Stemgenex suit proceeds as court implies stem cell clinic loopholes Read More »
Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some
Two physicians are central to something called the SCOTS trial, Dr. Jeffrey Weiss and Steven Levy. Patients have claimed negative outcomes after participating in the trial. What’s going on here? SCOTS trial The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning. More information has come out on negative
Dr. Jeffrey Weiss, SCOTS trial, & Patient Claims of Blindness Read More »
The world of stem cell clinics is on edge right now with a number of negative patient outcomes reported and lawsuits in play such as San Diego stem cell clinic Stemgenex being a defendant in a proposed class action lawsuit focusing in part on alleged problematic marketing claims on their website (see archived posts on the lawsuit).
LA Times Reports Stemgenex Doc Gets 3-Year Probation from State Medical Board Read More »
Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)? More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it
Does stem cell clinic IRB approval mean much? Insights from blinding cases Read More »
Happy St. Patrick’s Day from the Irish Stem Cell Foundation (www.stemcell.ie)! I’ve included a few picture from the parade here in Ireland. Scientifically, Ireland is going through a lean period. The national science funding agency SFI is having its first grant call in 2 years. If recent history is a predictor, they are more likely
On St. Patrick’s Day, an update on stem cells in Ireland by Stephen Sullivan Read More »
Do three blinded US Stem Cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image
NEJM paper links 3 blinded patients to US Stem Cell clinic 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
How Scott Gottlieb may transform the FDA’s approach to stem cells Read More »
Over the years and in particular after Dr. Oz’s show a couple weeks ago, I’ve heard from many patients who are absolutely convinced that stem cell therapies do in fact work and are safe. They have been focused particularly on hematopoietic stem cell therapy (HSCT) for MS but also other investigational applications using a variety of stem
Navigating 4 key kinds of stem cell studies Read More »