Happy science Friday and here’s a TGIF list of recent stem cell news and papers. The FDA warning letter to Richard Burt of Northwestern related to noncompliance issues with his stem cell clinic trial for MS has dominated the news recently, but some other notable things have happened as well on stem cells and more …
The FDA recently issued a lengthy warning letter to Northwestern University over the clinical trial practices of its Dr. Richard Burt and this letter just popped up on the FDA website. To my knowledge this is an unprecedented event as I’m not aware of another warning letter to a major university for a stem cell trial. Burt received the FDA …
By Amritha Jaishankar Happy Maryland Day from the Maryland Stem Cell Research Fund (MSCRF) at Maryland Technology Development Corp. (TEDCO)! This year, here at MSCRF, we are skipping the crabs, old bay and beer and choosing instead to spend the weekend engaged in scientific review! As we commemorate the day the first settlers stepped on to …
Guest Post from the Maryland Stem Cell Research Fund 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 »
A paper retraction is a major, painful step in science, but sometimes it is necessary and in the past few weeks we’ve seen news of two high-profile stem cell paper retractions. However, these retractions were handled entirely differently by those involved and were prompted by very distinct situations. Update: for some background on stem cell …
A tale of two stem cell retractions: stark contrast between Macchiarini & Egli Read More »
They say a picture is worth a thousand words and with stem cell clinics and GoogleMaps, maybe it’s true. When Leigh Turner and I published our stem cell clinic paper in Cell Stem Cell last year, Beverly Hills stood out as a top hot spot for these businesses selling non-FDA approved stem cells. See the GoogleMap image …
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 »
Ring the bell for a stem cell milestone, specifically for iPS cell work. There’s been a whole lot of commotion about the NEJM article yesterday documenting the experiences of three women with macular degeneration who were blinded by non-FDA approved stem cell eye injections of fat stem cells at a business in Florida, but in the …
Takahashi team IPS cell vision paper marks major stem cell milestone 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 »