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 »
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 »
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 »
Does it make any sense scientifically or medically to use stem cells for pain? I’m skeptical in most cases today. The whole idea of stem cells for pain has been on my mind for a number of reasons. For one thing, more stem cell clinics are marketing unproven stem cell therapies at a high price
Do stem cells for pain make any sense? Read More »
Last week I posted my list of 2017 predictions for the stem cell field. Today a couple of days into 2017 I’m more focused on hope than realism. What would I wish for in the stem cell and regenerative medicine arena in the coming year? More stem cell clinical trial data posted and published. There are
Stem cell wish list for 2017 Read More »
I’m hearing more questions from the community about alleged harm from stem cell clinics selling stem cells for a number of vision-related conditions and some concerns include the so-called SCOTS study. I first blogged about SCOTS early this year and back then I myself had questions too. Some commenters then raised concerns or questions about SCOTS in
SCOTS Study on Stem Cells for Vision: Still Questions as Patient Alleges Harm Read More »
In the total the FDA has held 3 days of public meetings on stem cells in the last few weeks ranging from science to policy and hearing from many parties including patients and even stem cell clinics so the big question now is, “what happens next?” The FDA has 4 draft guidances pertaining to investigational
What happens next with FDA & stem cells: lower your expectations? Read More »
What can go wrong with unapproved stem cell clinic offerings? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S. Thomas Albini, MD gave a talk entitled, “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”.
Negative stem cell clinic outcomes include 3 blinded women Read More »
For better or worse, I am in the unique position of being a stem cell scientist and also a former cancer patient. Looking on the bright side this gives me a unique perspective on things compared to many of my colleagues. I know there are thousands of people out there looking for more practical information
Patients guide to stem cell treatments for 2021 Read More »