September 19, 2020

The Niche

Knoepfler lab stem cell blog

StemImmune

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

6 min read

Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do about the hundreds of clinics currently marketing them without approval? If not, then how does the agency reconcile that with its past statements and even words this year under …Read More

2 min read

The FDA took some big action last week and issued a major statement today on stem cell clinics (see my post here). I asked Dr. Mark Berman of the Cell Surgical Network if he had any statement regarding the recent action and statement from the FDA today that involved flagship network member clinic, California Stem Cell Treatment Centers. Dr. Berman sent me the new press release from Cell Surgical Network, which you can read here. Amongst other things, the Cell Surgical Network PR makes some strong …Read More