fat stem cells

In landmark step, judge does not defer to FDA in stem cell clinic chain case, orders full trial

Judge-Jesus-Bernal

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 …

In landmark step, judge does not defer to FDA in stem cell clinic chain case, orders full trial Read More »

What is stromal vascular fraction or SVF?

SVF2

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 …

What is stromal vascular fraction or SVF? Read More »

In dark augur for clinic industry, court allows class action suit by 100s against Stemgenex

Stemgenex

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 …

In dark augur for clinic industry, court allows class action suit by 100s against Stemgenex Read More »

Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court

us-stem-cell-clinic

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 …

Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court Read More »

My take as a biologist on US Stem Cell “natural” claim in federal court case endgame

SVF2

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 »

Stem cell clinic doc being sued by FDA now gets agency warning for unapproved breast device

Elliot-Lander-and-Mark-berman-300x2331

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. …

Stem cell clinic doc being sued by FDA now gets agency warning for unapproved breast device Read More »

15 still unanswered interview questions for stem cells for vision SCOTS trial docs

George-Gibson-SCOTS-patient-screenshot-of-Sun-Sentinel-video-1

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 …

15 still unanswered interview questions for stem cells for vision SCOTS trial docs Read More »

Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women

stem-cells-eyes

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 …

Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women Read More »

What should we call “stem cell clinics” & is “snake oil” too harsh for some?

snake-oil-stem-cell-clinics

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 …

What should we call “stem cell clinics” & is “snake oil” too harsh for some? Read More »

Deconstructing FDA’s Mixed Bag Approach to Stem Cell Clinics

FDA-draft-guidance

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 …

Deconstructing FDA’s Mixed Bag Approach to Stem Cell Clinics Read More »