At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it […]
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »
Is the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients? Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval? Over the years I’ve reached out to
When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the
Stem cell clinics, FDA, & giant, unapproved for-profit human experiments Read More »
Every year I look into my stem cell crystal ball and make a top 10 list of stem cell predictions for the coming year. My predictions for 2015 will be coming up soon and I may bump them up to 20 predictions instead of 10 because there’s so much going on in the field. Stay
Stem cell crystal ball: how did my 2014 predictions fare? Read More »
Each year I make predictions for the stem cell field for the coming year. In today’s post I write about my top 10 stem cell predictions for 2014. You can see my predictions for 2013 here (see predictions for 2011 and 2012 predictions, which are kind of fun to read to see what was on the “mind” of the field
Stem Cell Predictions for 2014 Read More »
The World Stem Cell Summit in San Diego was a great meeting this past week. It was my 3rd straight Summit and the best of all. It’s a unique mix of science, medicine, and policy that links together key players from every corner of the field. I talked stem cells one-on-one or in small groups
Key Questions for the Stem Cell Field for 2014 Read More »
Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through
My response to ‘Our Bodies, Our Cells’ Harvard post on deregulation Read More »
Below are links to specific court documents and filings in stem cell-related legal proceedings. (I’ve also placed in parentheses links to my posts/analysis on these). Enjoy, especially you lawyers and investors. It’s a work in progress so expect more cases and documents to appear. In fact, if you have suggested additions please add them (plus
Your stem cell legal documents hub Read More »
I’m here at the World Stem Cell Summit in Florida. I just was in the audience for a great panel discussion on The Role of States in Regulating Stem Cell Therapies. It was contentious but raised almost all of the key questions in this area. There was particularly interesting and vigorous debate between two participants,
The FDA warning letter that Celltex received in late September (but that just went public yesterday–see my initial reaction here) is a possible game-changer for that company in my opinion. Why? The letter outlined in great detail the FDA’s concerns with how Celltex manufactures its stem cell product ranging from lack of documentation to concerns about aseptic/sterile
Will stem cell clinic Celltex reinvent itself after game-changing FDA warning letter? Read More »