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 …
New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »
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 …
When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the …
Stem cell clinics, FDA, & giant, unapproved for-profit human experiments Read More »
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, …
I recently interviewed Drs. Elliot Lander and Mark Berman of the Cell Surgical Network. It’s an affiliated chain of clinics selling stem cell interventions for more than a dozen medical conditions. You can read Part 1 here and Part 2 here of the interview where we cover 10 important questions. Today is Part 3, where I explain why their answers …
Cell Surgical Network Series Part 3: Key Concerns Read More »
I’ve been fortunate to interview some of the greats in the stem cell field for this blog and host debates between key players. Please note that just because I have interviewed folks does not mean I agree with them or that they agree with me. The point is to establish dialogue on key issues. As …
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) …
FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »
For years I’ve been writing about fat stem cell clinics that sell non-FDA approved stem cell “treatments” to vulnerable patients right here in America. These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in …
My new ‘neighbor’ in Sacramento: a fat stem cell clinic Read More »
Some American stem cell clinics that operate without FDA approval can give the appearance of being in the mainstream of academic stem cell research. Sometimes they go a step further to hint at or even say that they have some kind of federal approval as we saw in the past with the Stem.md website. Why …
I’ve really enjoyed day 2 of ISSCR 2014. So far this day has already packed in a slew of great talks both in the lecture halls and outside one-on-one with old friends and new ones. How great is that? I’ll focus on just a few highlights to keep it concise. Dubious stem cell clinics and …
ISSCR 2014 Day 2: Navigating Balanced Stem Cell Path to Clinic Read More »