At last year’s ISSCR 2010 Meeting in San Francisco, President Irv Weissman talked about the dangers of unvalidated stem cell treatments. He talked about the responsibility of stem cell scientists to stand against these and the importance for scientists not to endorse or serve on advisory committees of companies peddling such products and “therapies”. As […]
Stem cell tourism: from bad to worse from 2010-2011 Read More »
What is ISSCR doing about unproven stem cell clinics? One of the greatest and most infuriating ironies of the stem cell-based regenerative medicine universe is that while the FDA strictly regulates the progress of therapy development by Advanced Cell Technology (ACT) and Geron and other legitimate companies, at the same time mysteriously the FDA essentially
ISSCR KO’d in round one versus unproven clinics: where’s the FDA? Read More »
I’ve been lecturing on stem cells as a professor here at UC Davis School of Medicine for many years so I can answer common questions such as “What are stem cells?” The medical students ask many great questions. They are always interested in clinical applications. The goal of today’s article is to help you have
What are stem cells? Definition & applications Read More »
The Trump Administration just quickly gutted the FDA including key leadership. What is going to be the impact of this sudden purge? Former Commissioner Robert Califf recently said it is the end of the FDA as we’ve known it. Those are dramatic words, but they seem on the money to me. As a biomedical scientist
Why the FDA & CBER leadership purge will be so bad for biotech Read More »
In a landmark decision, today the FDA approved Ryoncil from Mesoblast for GvHD. This is the first time the FDA has approved a mescenchymal stromal/stem cell or MSC therapy of any kind. There have been many ups and downs for Mesoblast toward this approval of Ryoncil or remestemcel-L, an allogeneic marrow MSC product. See my
In landmark, FDA approves first MSC therapy, Mesoblast’s Ryoncil for GvHD Read More »
QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies. I see several specific red flags including a proposed class action lawsuit. The company reports having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands
QC Kinetix review: concerns on huge regenerative clinic chain Read More »
The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With
FDA warns Frontier Biologics as part of its more active trend Read More »
Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of
Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan Read More »
How might Trump’s nominee to lead the FDA, Martin Makary, change the agency? Should we be worried or hopeful? I’ve been closely following the FDA and its commissioners ever since I started The Niche in 2010. I’ve been particularly interested in how these leaders impacted FDA actions on cell and gene therapies. How might Makaray
What you need to know about Martin Makary and planning for the Trump 2.0 FDA Read More »
Some recent claims had me wondering whether Liz Parrish is the world’s most genetically modified person. She and her firm BioViva are making that claim. It’s an important question but maybe not for the reason many of us first might think. This is not really about one person. Instead, this is a weighty question because