June 1, 2020

The Niche

Knoepfler lab stem cell blog

Mark Berman

4 min read

By Jeanne Loring There has been news over the last few days about stem cell researchers pulling out from a documentary called “The Healthcare Revolution”.  First to report on June 15 was Erin Allday of the San Francisco Chronicle, followed by David Jensen’s California Stem Cell Report blog, Michael Hiltzik of the LA Times, and Beth Mole of ArsTechnica. The documentary is a multipart series that included interviews with people designated as “Episode Experts”.  I discovered last Thursday (June 13) that I was listed …Read More

5 min read

When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. Berman and his clinic partner, urologist Elliot Lander, run an adipose stem cell firm called California Stem Cell Treatment Center. This clinic seems effectively to also be the HQ …Read More

5 min read

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? Or will things heat up further? In the interview I did last week with Patti Zettler she mentioned the possibility of a voluntary stop by the clinics. The more …Read More

4 min read

The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point for dealing with the for-profit stem cell clinic problem in the U.S. Update: US Stem Cell says it intends to fight the DOJ in court. According to the Washington …Read More

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

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