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

Elliot-Lander-and-Mark-berman-300x2331

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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Counterpoints to Lovell-Badge & Daley’s CRISPR baby rationales

CRISPR-baby

Two prominent scientists, Robin Lovell-Badge and George Daley, have been amongst the most outspoken proponents of leaving the door open to heritable human genetic modification via CRISPR. While they each have articulated their reasons in somewhat different ways at times, their core reasons arguing in favor of future heritable CRISPR appear largely the same. In

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Autologous or Allogeneic: a stem cell question (guest post from Jeanne Loring)

stem-cells-and-development-parkinsons-disease

By Jeanne Loring What can you do with cells that live forever and can make every cell type in the body?  The answer is: remarkable things, as new reports of clinical trials using cell types derived from pluripotent stem cells indicate. Pluripotent stem cells are either derived from embryos donated from IVF procedures (human embryonic

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Red flag for Joint Commission for its gold seal approval to former stem cell clinic firm

The-Lung-Institute-Joint-Commission

The Joint Commission apparently has given some kind of seal of approval to the unproven stem cell clinic-related firm, the Lung Institute, or as it is now often called the Lung Health Institute. For me this raises concerns about the Joint Commission itself or at least its ambulatory care accreditation program through which Lung Health

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FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely

Dr.-Scott-Gottlieb

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a

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Is clinic firm US Stem Cell sued by FDA prepping for fat-free future?

fat-free

Is fat-free always a good thing…even for unproven stem cell clinics? It must be a challenge for a stem cell clinic firm like US Stem Cell, Inc. (USRM) to face an imminent possible future where it cannot sell injections of its main product, fat stem cells, in the US. After all, “US” and “Stem Cell”

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Trying to connect the dots on CRISPR baby story paints a dark, cloudy picture

connect-the-dots

When I was a little kid I played this game called “connect the dots” or “dot-to-dot”, where you draw a line from dot-to-dot in numerical order and at some point a picture starts to emerge. I think kids and even some adults still play this today. They even come in extreme versions with hundreds or

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Several new investigations expose ‘snake oil’ stem cell clinics

snake-oil-stem-cell-clinics

We need more investigations of for-profit stem cell clinics selling what some view as ‘snake oil.’ Over the years I’ve mainly resisted using terms like “snake oil,” but that phrase is being used more often and more recently I think we need to be blunt about what is being sold. Part of effectively countering the

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Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex

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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