FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some …
Take-homes from new FDA NEJM stem cell piece including surprises Read More »
Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The …
New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »
University of Minnesota bioethicist Leigh Turner has been threatened with a lawsuit by a stem cell clinic-related business. Lawsuit threats in this arena come up every so often and as much as they are unpleasant realities, they can also reveal some important aspects of the stem cell arena. Ars Technica reported yesterday that Leigh’s recent paper …
Stem cell clinic-related biz threatens researcher with lawsuit, wants retraction Read More »
A stem cell/regenerative clinic firm called the Lung Institute is facing a filing of a proposed class action suit. Update: Note that this firm also goes by the name the Lung Health Institute and now as of 2019-2020 it does not appear to offer stem cells anymore, perhaps focusing on PRP. You might also find …
Class Action Lawsuit Filed Against Clinic Lung Institute Read More »
A new article by Honor Whiteman in Medical News Today (MNT) on a Mexico stem cell clinic really takes the prize so far in 2016 amongst media pieces that engage in stem cell hype. Update; Many on Twitter are calling for retraction of this MNT article. The MNT article entitled “Stem cell therapy: is the US …
Medical News Today article reads like an ad for Mexico stem cell clinic Read More »
The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) …
FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »
For years I’ve been writing about fat stem cell clinics that sell non-FDA approved stem cell “treatments” to vulnerable patients right here in America. These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in …
My new ‘neighbor’ in Sacramento: a fat stem cell clinic Read More »
Spock was always my favorite Star Trek character, and even if Leonard Nimoy was not Spock, it seemed to me that there was much of Nimoy in Spock. And for many of us scientists there was some of Nimoy and Spock in us too. The news of Nimoy’s death was a bit of a shock …
Could Spock Style Stem Cells Have Saved Leonard Nimoy? Read More »
In about a month my new book, Stem Cells: An Insider’s Guide, should be available as an e-book from the publisher and from Amazon. It’s available for pre-order now at Amazon here. The “real” book (i.e. the one made of paper) should be available in September. The book costs $29. Any writers out there interested in doing …
Stem Cells An Insider’s Guide: More on My New Book Read More »
What really happened at XCell-Center in Germany, formerly the largest stem cell clinic in Europe? A baby died after receiving treatment there. Why? Was the death in any way connected to stem cells? (update: note that since post originally went up, quite a few more patient deaths both a clinics and in clinical trials have …
Commenter Claims XCell-Center Stem Cell Clinic Got a Bad Rap, Provides New Details Read More »