fat stem cells

Striking FDA Hahn & Marks JAMA pub on regenerative clinics

Dr-Stephen-Hahn-Commissioner-of-FDA

It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other …

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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 judgement 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 …

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StemGenex clinic bankruptcy reveals surprises including huge revenue

Stemgenex

How much money and how many patients do stem cell clinics like San Diego’s StemGenex make each year? A new court document has some insights from an unexpected angle. I’ve been following StemGenex for years here on The Niche. It’s been a rollercoaster ride. Things hit a new low today, perhaps marking the operational end …

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Kristin Comella resigns from embattled clinic firm US Stem Cell

Kristin-Comella

US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to …

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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 …

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DIY injection of US Stem Cell product, video after court loss

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A fitness guru named Ben Greenfield has now reported self-injecting non-FDA approved stem cells from US Stem Cell. He says the stem cells came from a clinic that lost a big federal court case 9 days ago. Greenfield posted a Facebook video of the actual injection, which he narrates. There’s some text along with the …

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Fallout of big court loss for stem cell clinic whose leader tweeted conspiracy claim

Comella-tweet-on-FDA

As I broke the news yesterday, the high-profile fat stem cell clinic firm U.S. Stem Cell (USRM) just lost a groundbreaking court case. Here is the FDA’s official reaction today to the court ruling. Also, since the ruling major media have been covering the court ruling. Here are some examples: From the Washington Post from …

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

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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 …

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FDA needs to quickly act against IRBs enabling risky fat stem cell clinics

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Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by …

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Clinic biz US Stem (USRM) may be kaput in matter of weeks or months

Joint-motion-for-summary-judgement-1

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, …

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