SVF

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

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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 …

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What is stromal vascular fraction or SVF?

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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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Can clinic biz US Stem reboot after losing suit? Its email to customers & more

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The unproven stem cell clinic firm US Stem Cell Inc. is in a world of hurt. If a federal judge says you can no longer sell your key commercial offering, how do you survive as a company? US Stem probably has been thinking about that possibility for months. Still, it’s not yet clear where the …

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Reactions to historic stem cell clinic court loss, new court order, & what happens next?

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It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently). …

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

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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 …

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FDA warning points to tougher regulation of fat stem cells & clinics

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Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment …

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FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US

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The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) …

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Interview with Bioheart CSO, Kristin Comella including on FDA

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I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem …

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Stem cells sold for better sex part 2: bigger & better penis?

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Does size matter when it comes to a guy’s penis? Can a man get bigger and could he do it via stem cells? Today’s post is the 2nd in a series on stem cells being sold allegedly for a better sex life. You can read the first post here. An increasing number of men around the world …

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