As I first reported, the FDA conducted a two-week audit of Texas adult stem cell firm, Celltex, sometime in April. Today I received a copy of the so-called “483 report” of that audit. It is basically a summary of problematic issues that the FDA says need to addressed. The FDA report is cause for some […]
Surprising FDA audit report of Celltex a blow to dubious stem cell clinics Read More »
Celltex is an adult stem cell company in the great state of Texas that reportedly has produced adult stem cell products used for the treatment of more than 100 patients with stem cells. We don’t know much about Celltex (e.g. it has no website), but I was hoping to change that in part via a
Predictions heat up on FDA audit of Celltex Read More »
The International Cellular Medicine Society (ICMS) is viewed somewhat skeptically by the stem cell community, but they are undeniably an important player in the stem cell world. A few weeks ago I interviewed ICMS President, Dr. Ricardo Rodriguez (see interview here), and then I provided recommendations here to the ICMS to improve their organization including a less adversarial
ICMS posts 483 report of FDA audit: still awaiting news on Celltex Read More »
The FDA has been busy with stem cell-related activities this spring including with ICMS. Busier than publicly apparent. Very busy, indeed! Earlier, I reported that they issued a warning letter to cosmetician to the stars, Dr. LookGood, as well as one to another doc selling stem cell therapies. Now it seems apparent that even more
FDA visits both ICMS and reportedly Celltex 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 »
What are the top 10 stem cell events of a crazy 2012 to date? Based on this wild list in just over 3 months, I would say 2012 overall will prove to be a memorable one. 1. Celltex and McGee versus University of Minnesota’s Turner and Elliott. Glenn McGee, at one point both editor of American
Stem cell stories of a crazy 2012 so far including Celltex Read More »
Recently, there has been a brewing controversy surrounding a journal called American Journal of Bioethics (AJOB), a company called CellTex, a bioethicist named Dr. Glenn McGee who founded and used to run AJOB until he recently resigned, and two University of Minnesota professors, Drs. Carl Elliott and Leigh Turner who have been publicly critical of
Celltex versus University of Minnesota: support for Elliott and Turner Read More »
A recent article in Nature News about a stem cell transplant company called Celltex got me thinking again about safety. The safety of stem cell-based therapies is kind of an obsession of mine. A question comes to mind. Are people realistic about what stem cells can do for them and the risks involved? The answer
Celltex, RNL and phony worst case stem cell scenario comment Read More »
The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA. If SCOTUS takes the case, the FDA could find its powers
FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in Read More »
I’ve been following the stem cells for COVID arena for more than two years. During this time researchers have launched scores of trials. A few have been published including a new one. It’s been a wild ride that at times has included politics and an odd cast of characters. There was Rick Perry and also Rudy Guiliani getting
A close look at new stem cells for COVID trial pub Read More »