October 19, 2020

The Niche

Knoepfler lab stem cell blog

FDA

2 min read

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 of documents is limited at this time because, to quote them, “The FDA inspection of CellTex is still open”. Note that the FDA refers to the company with an internal …Read More

3 min read

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 the US v. Regenerative Sciences Inc. (RSI) case providing helpful and insightful perspectives on the history of the case and their prediction as to the likely outcome on appeal. …Read More

1 min read

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 of the stem cell field, what would it be? I realize some people may want to click more than one, but try to pick just your #1 in the …Read More

2 min read

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 there is no science behind their expensive creams and treatments or that they do not have FDA approval. Today the FDA gave the stem cell cosmetics field a wake …Read More