June 6, 2020

The Niche

Knoepfler lab stem cell blog

Dr. Elliot Lander

5 min read

We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters. Was that the goal? What’s the deal? As to the stem cell clinic referring to itself as CIRM, some of us in the stem cell world already know of …Read More

6 min read

Does a new lawsuit including Cell Surgical Network and its leadership as defendants pose a broad test to this entire chain of stem cell clinics, which may be the largest such affiliated clinic group in the U.S. and potentially even in the world? Will lawsuits substantially impact stem cell clinics? Lawsuits against unproven, for-profit stem cell clinics seem to be growing in numbers the last few years. Some of us have been speculating on the potential impact of such lawsuits as I’ve written here and …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

3 min read

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with …Read More

4 min read

Is the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients? Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval? Over the years I’ve reached out to interview many members of our diverse community in the stem cell arena including those operating stem cell clinics. One past such past interview (here and here) was with the …Read More

1 min read

The Cell Surgical Network is a for-profit network of clinics offering various stem cell-related interventions, which began with the California Stem Cell Treatment Center. I have interviewed Drs. Elliot Lander and Mark Berman of the Network in past (Part 1, Part 2) and I raised some concerns about the network in a follow up Part 3 post, which was replied to in a lengthy comment by Dr. Berman. In the course of this dialogue it was indicated that Cell Surgical Network had an IRB through the International …Read More