I’m enjoying Celltex’s new website and I’m appreciative of their great responsiveness to my questions. Transparency is a beautiful thing! My latest question to them was whether they, given that the FDA called them a “drug manufacturer”, are now planning to or have already filed an IND. An IND is an application for an investigational […]
More Celltex Q&A: we are not a drug manufacturer Read More »
How does Texas stem cell clinic Celltex make their stem cell drug? This is a very key question as the answers will help the stem cell field evaluate this drug’s potential safety and efficacy. I’m calling it a “drug” because the FDA called Celltex a “drug manufacturer” and by all past FDA precedent as well
My ongoing Q&A with Celltex on their stem cell drug production methods Read More »
Today there is an editorial piece in the WSJ about the recent court ruling giving the FDA authority to regulate stem cells grown in culture as drugs. As a stem cell scientist, I read this opinion piece with interest. Unfortunately it is behind a paywall, but I have outlined and discussed the key issues below.
WSJ editorial on issue of stem cells as drugs misses the boat Read More »
Are we ready to start using iPS cells in patients in the near future? Say in just a couple years? Are they ready for primetime? I think the answer is clearly “no”. I believe that iPS cells, a new type of stem cells, are one of the most exciting and important developments in biomedical sciences
iPS cells not quite ready for primetime? Read More »
I love paradoxes. The great artist M.C. Escher was famous for his paradoxical drawings such as the one above. Paradoxes make people think in a whole new way about something they thought they understood. The stem cell field is full of paradoxes. Below I list my favorite ones. Some of these resonate with stem cell
Intriguing stem cell paradoxes: from Pepsi to Pluripotency Read More »
A Korean stem cell clinic has been sued. For the first time to my knowledge, patients have sued a dubious stem cell clinic (RNL Bio) for fraud. As one stem cell expert has put it (see below), now there is “blood in the water”. RNL Bio of Korea has reportedly (hat tip to Leigh Turner) just been
Korean stem cell clinic sued by patients in U.S. for fraud: RNL Bio Read More »
Lee Buckler is a true stem cell industry guru. As I’ve been writing this blog for the last couple years it has served as a catalyst for me to meet dozens of really interesting people including. Given all the complex events of late in the stem cell field, I asked Lee if he would do an
Great interview with Lee Buckler on stem cell industry, regulatory issues, and Celltex Read More »
It’s only Wednesday and it’s already been a big, bumpy week for Texas stem cell company, Celltex. On Monday, the FDA report of their two-week visit to/audit of Celltex became public thanks to the efforts of Dr. Leigh Turner and Houston Chronicle reporter, Todd Ackerman. Now there is more complicated news for the company. A
Celltex is sued by former employee Read More »
Last year one of the biggest events in the stem cell field was biotech Geron punting its embryonic stem cell (ESC) program. Much consternation followed. Some folks opposed to ESCs happily pronounced ESC research dead. Some folks in favor of ESC thought the world was ending a year early. Others tried to look on the
The stem cell gestalt of Geron Goodbye and the future of ACT Read More »
Why is the Texas stem cell company Celltex so super duper private about itself? I’m not sure. It has been the subject of much discussion in the stem cell field in the past year. Unfortunately, much of the news has been negative, largely related to their former head of ethics, Glenn McGee, who also was
Wondering why Celltex is still so silent Read More »