Search Results for: fat stem cell

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

February 1, 2021 / By / 26 Comments
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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

February 1, 2021 / By / 3 Comments
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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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Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex

June 8, 2022 / By / 3 Comments
Stemgenex

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 …

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When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon?

February 1, 2021 / By / 2 Comments
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Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? …

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Fat stem cells are drugs: new FDA final guidances

September 3, 2022 / By / 8 Comments
FDA stem cell policy flow chart.

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …

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Providing key context for my quote in WSJ on fat stem cell clinics

February 1, 2021 / By / 8 Comments
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Journalist Melinda Beck has a new piece on fat stem cell clinics in the Wall Street Journal (WSJ) today that includes one very brief quote from me that I believe effectively ends up being an unintentional misquote because of a lack of context. Here in this blog piece I want to provide that important missing …

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‘Are fat stem cell clinics selling unapproved drugs?’ reporters ask in talking about our new paper

February 1, 2021 / By / 18 Comments
SVF2

Our new paper in the journal Cell Stem Cell on the large stem cell clinic marketplace in the U.S. documented a wide range of different kinds of clinics, stem cells used, and conditions claimed to be treated, but here I want to focus on the fat stem cell clinics in this post. I’m going to try …

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Woman’s death after “no big deal” fat stem cell therapy: coroner investigating

February 1, 2021 / By / 20 Comments
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An elderly woman in Australia reportedly died shortly after receiving a fat stem cell transplant. Sheila Drysdale passed away hours after getting an adipose stem cell treatment a few days before Christmas in 2013. That death is now being investigated by the coroner there. Not only is this death in Sydney distressing in it of …

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

February 1, 2021 / By / 10 Comments
FDA

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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