September 20, 2020

The Niche

Knoepfler lab stem cell blog

FDA Warning Letter Stem CElls

3 min read

One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog. What does a warning letter really mean? What triggers it? Why do some businesses selling stem cells get inspected and others don’t? What do some entities get warning letters over the years, while …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

The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) chain of clinics, but it seems it is no longer listed on the CSN website. You can see, however, that Gionis and Irvine are listed on this archived page …Read More