July 11, 2020

The Niche

Knoepfler lab stem cell blog

adipose stem cells FDA

2 min read

Stem cell studies continue to make big news with a mixed bag of trends, and some good stem cell news and others not so much. Mesoblast ($MESO) had its stock suspended for quite so time recently in anticipation of a big announcement. When that news came today it was discouraging in the form of its partner Teva choosing to end their relationship with Mesoblast on a stem cell heart disease trial. Mesoblast spun this as something good that they regained the rights from Teva, but investors …Read More

3 min read

Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment and finalizing draft guidelines related to stem cell clinical products including fat stem cells aka adipose stem cells and stromal vascular fraction or SVF. Even so, the FDA just …Read More

4 min read

With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem cell “treatments” to patients and almost all of them use non-FDA approved stem cell products isolated from fat tissue. The clinics have argued that they do not need FDA …Read More