Next month there is going to be a new stem cell meeting taking place. The 1st Annual Houston Stem Cell Summit. The primary sponsor is Celltex. I’d encourage everyone to go, but I’m not so sure it’d be worth it. Why? I’m always glad to see another stem cell meeting and this one is surely unique in […]
Houston stem cell meeting lacks diversity & risks falling to groupthink Read More »
I’ve been in the stem cell field for a long time. I’ve seen a lot of wild, unexpected, even crazy things. Running this blog is a big reason. However, I have never seen anything like the wild video (see below) with a sock puppet (manned by comedienne Cheryl Ling) erupting with a profanity-laced tirade about stem
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 »
Are stem cells drugs? At least for today, a federal court unambiguously ruled that the answer to this question for manipulated stem cells is “Yes”. The story has been reported in the media at New Scientist and Scope Blog. You can read over the key issues here. The court ruled in favor of the federal government and FDA and against
Court empowers FDA to regulate stem cells as drugs 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 »
Celltex has issued a press release (PR), entitled “Company Pioneering Regenerative Medicine Services Invited FDA to Inspect Lab” on their FDA audit in response to the reaction in the media and stem cell community about it. I view this PR as a step in the right direction–more openness! There is a lot of info in
Please note that this is one of the only instances in the history of this blog that I have retroactively edited a post for what I believe was an error on my part related to what I feel was overly extreme verbiage. I have also subsequently been informed confidentially of more of the facts of
Rick Perry visits human embryonic stem cell lab at Scripps Institute Read More »
I have interviewed two folks on the very important US vs. Regenerative Sciences legal case: Dr. Chris Centeno and Doug Sipp. More background on the case can be found at the FDA Law Blog. I thank them both for their time and for sharing their unique perspectives. I have specific rules for these interviews and
Centeno and Sipp interview on FDA stem cell oversight Read More »
LinkedIn is a professional social networking website. Most of you probably know it and are probably members. I have liked LinkedIn, but was so disappointed to find out that they regularly engage in censorship. Really? Yep, read on. Many people find it a very valuable resource for networking, but it also is supposed to serve
LinkedIn Censorship Read More »