In response to a FOIA request, the FDA informed me that they are continuing to investigate Texas stem cell clinic, Celltex. The firm has been flying somewhat under the radar lately. They have not responded to multiple requests for comments on various issues. The FDA indicated to me that what they can release in terms […]
FDA still investigating clinic firm Celltex Read More »
Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through
My response to ‘Our Bodies, Our Cells’ Harvard post on deregulation Read More »
The FDA is faced with years of a static budget and a rapidly growing stem cell and cell therapy for-profit sector. It also faces criticisms (some that it has acknowledged are legit) from certain folks in the stem cell field. If you could change just one thing about the FDA in terms of its oversight
What Would be Your #1 Top FDA Reform on Stem Cells? Take our poll Read More »
Stem cell cosmetics is an exploding area ranging from facial creams (e.g. from L’Oreal and its Lancome) to face lifts to boob jobs to baldness treatments (see two key posts here and here for background and great stories). The stem cell cosmetics field has not been held back by issues such as the fact that
L’Oreal Lancome gets hammered by FDA, why kid gloves for clinics? Read More »
I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below: Dear Dr. Knoepfler, Thank you for your interest
Celltex unsure if FDA agrees product isn’t a drug, but expects 2nd FDA visit soon 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 »
Stem cells grown in culture are drugs. Agree or disagree? I believe it is a correct statement. I don’t think it is even a question any more as it was a few months ago. Yes, I am convinced that the FDA, as supported by a recent federal court ruling, has it right that growing stem
2 decades as cell biologist tell me grown stem cells are drugs 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 »
A major scandal has erupted further regarding FDA monitoring of its scientists’ emails as reported by the NY Times. The FDA spied on the emails of its own scientists and other scientists. Some of the emails also involved correspondence with Congress and even the White House. Regardless of one’s position on what the FDA did,
Celltex is that adult stem cell company that treated Governor Perry and upwards of 80 other people with stem cell products that they grew in their lab in Texas. I wonder what the leadership of Celltex is thinking right now about its FDA audit, their future, and that pesky professor/blogger in California…what’s his name? I