May 30, 2020

The Niche

Knoepfler lab stem cell blog

FDA fat stem cells

7 min read

Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The latter is an affiliated group of dozens of stem cell clinics across the U.S. generally marketing experimental adipose (fat) stem cell therapies, sometimes called “stromal vascular fraction” or SVF). As …Read More

2 min read

Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to reach out to the FDA to clarify the process. PK: When the FDA issues draft guidances is it a standard approach to have a public meeting of the kind …Read More

6 min read

Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of 2020, the FDA has now clearly defined fat stem cells as drug products and filed suit against two firms marketing unapproved fat stem cells.) These new FDA guidances indicate …Read More