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

USRM-clinic-email

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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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

R3-Stem-Cell-testimonials

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a

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CRISPR baby moratorium grows likely with rising tide of support including from biotech

CRISPR-gene-edit-vs-mutation-1

Trying to make a CRISPR baby any time soon would be a really bad idea. How bad? Last December 3rd I penned a piece for STAT News arguing for a moratorium on the heritable use of CRISPR in humans. This potential future, radical application of “gene editing” is now often colloquially referred to as “CRISPR

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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the

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Stem $ell$: clinic marketeers dangle big bucks to docs

stem-sells-marketing

Over the last couple of years the marketing of unproven clinic injections of non-FDA-approved stem cells seems in open-throttle mode. What used to just be on the web here and there is now on billboards, newspapers, flyers, infomercials, and on TV. It’s possible that millions of dollars are being spent yearly on advertising this stuff,

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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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