In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgment against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a permanent injunction. You can read the new ruling here. The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of …Read More
fat stem cells
When people discuss “fat stem cells” they usually mean something called “stromal vascular fraction” or SVF. While references to fat or adipose stem cells can sometimes mean non-SVF materials, these days adipose SVF gets the most attention. But, does anyone have a clear picture of this biologic? Fortunately, it’s starting to come more into focus in recent years and I’ve updated this post in late 2020. What is Stromal Vascular Fraction or SVF? | What cells are in SVF? | What about MSCs …Read More
In the latest blow to the unproven stem cell clinic industry, a California federal district court judge just granted class status to a lawsuit against the fat stem cell clinic Stemgenex. (update: Stemgenex has since filed for bankruptcy). What this means in practical terms is that the lawsuit alleging fraud in marketing by the clinic firm amongst other allegations will proceed and may have 100s of patients involved. Many of these people paid nearly $15K per treatment to the company. Presumably some customers got …Read More
In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S. It’s a big victory for science, regenerative medicine, and patients. …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 that the feds will prevail, but it seems worthwhile to look at some of US Stem Cell’s arguments. Note as a sort of disclaimer that I’m not an attorney …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. 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
There’s a lot going on in Florida with non-FDA approved stem cell offerings even just related to stem cells for vision problems alone, but while US Stem Cell has drawn the most attention related to patient allegations of severe vision loss in Florida after fat stem cell injections in eyes, another group I’ll loosely call the “SCOTS Trial” has also been injecting investigational stem cells (in this case from bone marrow) into patients’ eyes and some patients have made allegations of harm there too in …Read More
Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months ago. Some of the cases of lost vision reportedly were documented by independent physicians including Dr. Thomas Albini. In 2017, the FDA issued a warning letter to USRM’s business U.S. Stem …Read More
Is “snake oil” too harsh a term for some of what is sold at some of the worst stem cell clinics? Is the phrase “stem cell clinics” itself accurate and useful in a broad sense? When we read or write the phrase “stem cell clinics”, most people generally know what we’re talking about, but it is not a very precise use of language, especially these days with so many different clinics out there, and there is a lot of room for error. There are …Read More
In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to deal with the highest risk stem cell clinics, but unfortunately the FDA sent mixed messages on clinics in a broader sense and in some ways left the door open …Read More