January 26, 2021

The Niche

Trusted stem cell blog & resources

California Stem Cell Treatment Center

3 min read

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in supply. Why did Liveyon chose to halt sales at least for the moment? By comparison other clinic-related firms have continued business as usual despite various FDA actions against them …Read More

4 min read

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest untitled letter went to RichSource Stem Cells, Inc. and its CEO Sara Oracle, a firm which markets an unusual “combo” product described this way by the FDA, “a combination …Read More

4 min read

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a lot of subtext in the FDA letter and accompanying PR, in my view none of it good for the company or its “centers of excellence.” The R3 website also …Read More

3 min read

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, they are both filing motions asking for summary judgment and asked for more pages to make their respective arguments. Things are moving fast now. Everything is due tomorrow to …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

4 min read

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 ever for predictions. We’ll see if I can match that here for 2019. I doubt it. However, I do think my prediction that 2019 will be the worst year …Read More

2 min read

Is fat-free always a good thing…even for unproven stem cell clinics? It must be a challenge for a stem cell clinic firm like US Stem Cell, Inc. (USRM) to face an imminent possible future where it cannot sell injections of its main product, fat stem cells, in the US. After all, “US” and “Stem Cell” constitute its name. Ouch. It’s probable that a year or so from now the FDA lawsuit against USRM will be over and the “fat stem cell lady” will have sung …Read More

3 min read

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class …Read More

2 min read

Take our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019? To be clear, I am asking for your predictions, not what you hope will be the situation a year from now. U.S. Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center along with its parent stem cell clinic chain Cell Surgical Network were separately but in parallel sued in May by the FDA via the DOJ seeking permanent injunctions …Read More

3 min read

For me there was a sense of “finally” when just under 3 months ago the FDA filed suits via the DOJ against 2 stem cell clinic firms, U.S. Stem Cell (and its affiliate U.S. Stem Cell Clinic, collectively referred to here as USRM) and California Stem Cell Treatment Center/Cell Surgical Network (collectively referred to here as CSN) seeking permanent injunctions. However, since the filings in May not much of anything has changed on these fronts and it appears that the FDA has taken no action …Read More