US Stem Cell Clinic

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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Permanent injunction on clinic firm US Stem Cell is big blow to fat clinics

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Today the United States District Court of the Southern District of Florida entered a permanent injunction against stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmed by the unproven treatments sold by these firms. US Stem had lost the case a couple weeks back, but now …

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

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

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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. …

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Attorney Jaffe, fan of less oversight, still clobbers Florida stem cell clinic firm

Richard-Jaffe

Attorney Richard Jaffe, who has been an advocate for clinics to have the right to sell and patient to buy unproven therapies such as the stem cells sold by clinics and unproven cancer therapies, just did a kind of shocking u-turn on a specific point. Jaffe and I have very different philosophical views of the …

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10 questions on FDA suits targeting stem cell clinics

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The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally …

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In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms

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The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point …

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Clinic biz US Stem Cell reports SEC subpoena, adding to uncertainty on its future

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The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the …

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Take-homes from new FDA NEJM stem cell piece including surprises

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FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some …

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