July 12, 2020

The Niche

Knoepfler lab stem cell blog

FDA stromal vascular fraction

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

3 min read

The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally thought in the for-profit stem cell clinic field. “Industry” apparently hasn’t been happy about this. For instance, December 2014 FDA draft guidance very clearly indicated that fat-related stem cell products …Read More

1 min read

I recently ran a poll on my blog about how the FDA is doing on handling stem cell clinics. There is substantial debate in the stem cell arena about how the FDA handles stem cell clinics ranging from the view that the agency is far too strict to excessively lenient. The results of the poll reflect a great deal of dissatisfaction with the job that the FDA is doing on stem cell clinics. Only 9% of respondents felt that the FDA is currently do …Read More