January 25, 2021

The Niche

Trusted stem cell blog & resources

Month: March 2017

1 min read

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 generally in science. I’ve posted some notable news bites below. More insights on molecular mechanisms of control of cancer stem cells and potential ties to metastasis from Nature paper …Read More

2 min read

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 warning letter late last year for a number of serious problems with his stem cell trial including failure to promptly report patient deaths to the FDA. Another issue noted …Read More

3 min read

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 Maryland soil, the MSCRF program steps onto new grounds as well! MSCRF was created to promote state-funded stem cell research through grants to public and private entities in Maryland. …Read More

5 min read

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 not being careful enough or even outright enabling risky behavior by those selling non-FDA-approved, experimental stem cell “treatments”? It can be hard to really be sure. What makes this area particularly muddled …Read More

2 min read

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 manuscript retractions more generally see from Retraction Watch here and from this blog here. In the case of a JCI stem cell manuscript retracted by Dieter Egli’s lab, a central problem …Read More

2 min read

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 from a search today above with the search terms, “Stem cells Beverly Hills”. According to GoogleMaps, just drive down Wilshire Boulevard through Beverly Hills and you could sample many of …Read More

2 min read

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 to fund grants based on geography (which centre or college you are associated with) and how quick the perceived economic benefit will be. This means information technology (particularly areas …Read More

2 min read

Ring the bell for a stem cell milestone. 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 same issue of the journal there also was some encouraging stem cell news that came in the form of essentially a mirror image of the bad news paper. We can call it the “stem cell …Read More

4 min read

Do 3 blinded 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 from a new NEJM paper reporting the severe adverse outcomes. The red areas are hemorrhaging with other substantial damage to the retina as well. How did this all happen? Last year the …Read More

5 min read

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