Search Results for: stromal vascular fraction (SVF)

Patients stem cell Q&A#1: can clinic injections cause GVHD?

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People ask me questions about stem cells all the time so I decide to do a new blog series answering your questions. Today’s post is  the first in this new stem cell Q&A series. Past series have included my Elephant in the Lab series that provides some insights into the craziness that sometimes goes on …

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Why did clinic supplier Liveyon halt sales while others have kept going despite FDA actions? Some insights including from John K

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Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in …

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

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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 …

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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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NY stem cell clinic pushes back on lawsuit by AG

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Unproven stem cell clinics are facing a variety of lawsuits these days including two prominent cases filed by the FDA. There are widespread patient suits against clinics as well. In April we saw a new kind of suit in the form of the NY State Attorney General (AG) Letitia James filing against a Manhattan clinic. …

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Sexual Medicine Society on Unproven Regenerative Therapies for Erectile Dysfunction

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There are many potential causes of erectile dysfunction or ED and a host of ideas about how to treat it. Some approaches to erectile dysfunction are evidence-based and even have been rigorously proven such as the drugs Viagra and Cialis, which increase blood flow to the penis. Depending on the causes of the dysfunction, these …

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FDA Interstate Commerce Regs Surprisingly Broad, Major Implications for Stem Cell Clinics

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The FDA mandate to regulate drugs and devices often invokes a term called “interstate commerce”. Like many people I thought I knew what that meant, but probably like most people I was wrong. After a great discussion on an original post on various key issues related to the many stem cell clinics doing non-FDA approved …

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New Interview with FDA on Key Stem Cell Regulatory Issues & Its Own Research

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It’s been a seemingly rather quiet year on the regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank the …

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