Stem cell clinics like Nervana are spreading like wild-fire across the U.S. A few months back the Sacramento area got a new stem cell clinic selling amniotic stem cell therapies for a variety of ills including most prominently arthritis and pain. This clinic is called Nervana Stem Cell Center. I first noticed it via a […]
Stem cell clinic Nervana new ad claims no side effects & FDA OK Read More »
One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog. What does a warning
To stem cell clinics: do your homework & take FDA “current thinking” seriously Read More »
Should we be injecting bone marrow cells into someone’s eyes? it seems like a terrible idea to me based on what we currently know. Whenever I see a stem cell headline like this one from a recent Baltimore Sun piece, it raises many questions: Stem cells apparently reverse woman’s blindness. First of all, is the reporter,
Study injects marrow cells into eye, charges $20K Read More »
Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment
FDA warning points to tougher regulation of fat stem cells & clinics Read More »
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 »
The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally
More tough FDA draft guidance on stem cells…still no action Read More »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 »
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 »
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
FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet? Read More »
With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem
FDA Draft Guidance Views Fat Stem Cells As Drugs Read More »