IntelliCell BioSciences, Inc. of New York, a clinical stem cell establishment, has had a rough time of it lately. For example, a recent piece of bad news is that there is an impending foreclosure sale of the company’s assets. What exactly that means for the company more broadly remains unknown, but a few people tell me (take this […]
New FDA IntelliCell BioSciences, Audit Report: A Lot of Work to Do Read More »
What does homologous use mean? Navigating the arena of clinical use of a biologic such as stem cells or differentiated cells made from stem cells can be challenging. There are many important issues including what defines “minimal manipulation” of biologics such as cells. One particular issue that is critically important and has drawn less attention
Time to bone up on homologous use in the stem cell field Read More »
Celltex is still in the mix with the FDA and who knows how that will turn out. Several documents were revealed via FOIA that provide insight into the goings on at Celltex since 2012. Two documents are letters from Celltex to the FDA dated April 27, 2012 and May 18, 2012, while a third is a
Celltex letters to the FDA revealed by FOIA: first is reaction to Leigh Turner Read More »
I have some interest in robotic surgery. About three and a half years ago I had surgery for prostate cancer and my surgeon used the da Vinci robotic surgery device made by Intuitive Surgical Inc (ISRG). At the time, da Vinci seemed new and exciting, but the device and the company have become more well-known
Intuitive Surgical (ISRG) Gets Problematic FDA Inspection Report Read More »
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 »