The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow […]
Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry Read More »
It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains
My take as a biologist on US Stem Cell “natural” claim in federal court case endgame Read More »
The New York State Attorney General (AG) filed suit this week against a Manhattan stem cell clinic. It’s a landmark case. The defendants are Image Plastic Surgery, LLC, Park Avenue Stem Cell, and Joel B. Singer, M.D. The clinic markets adipose stem cell injections for a variety of health conditions. Park Avenue Stem had belonged
Why NY AG suit against Manhattan stem cell clinic is such a big deal Read More »
In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further,
Clinic biz US Stem (USRM) may be kaput in matter of weeks or months Read More »
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.
The birth-related stem cell clinic industry is a serious problem for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections. Zombie stem cells One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was
Sales of zombie stem cells continue to mushroom Read More »
The Joint Commission apparently has given some kind of seal of approval to the unproven stem cell clinic-related firm, the Lung Institute, or as it is now often called the Lung Health Institute. For me this raises concerns about the Joint Commission itself or at least its ambulatory care accreditation program through which Lung Health
Red flag for Joint Commission for its gold seal approval to former stem cell clinic firm Read More »
For a long time at the end of each year, I’ve been making stem cell predictions for the coming year. Most often I’ve been making a “top 20” list of predictions and today’s post has my list for 2019. You can see how I did for 2018 here, which might have been my best year
20 stem cell & regenerative medicine predictions for 2019 Read More »
Each year I make a list of stem cell predictions for the following year and I’ll release my predictions for 2019 soon, but first I’m grading how my 20 predictions for 2018 turned out. It seems I did better than usual predicting what would happen this year. I only got a couple partial credit or
Good final grades on my 20 x 2018 stem cell predictions Read More »
The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a
FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely Read More »