Search Results for: warning letter

StemGenex, unproven clinic sued by patients, morphs into Advanced Cell Medicine?

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Holly-Bergen-StemGenex

The  unproven stem cell clinic StemGenex appears to now be called Advanced Cell Medicine. StemGenex is facing a proposed class action lawsuit by patients and it also recently received an FDA warning letter. StemGenex is notable too in that it seemed to be considering taking some extreme action against perceived critic websites including potentially the […]

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

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us-stem-cell-clinic

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 cautions R3 Stem Cell & 50+ stem cell clinic affiliates

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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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FDA needs to quickly act against IRBs enabling risky fat stem cell clinics

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alphabet-soup-819x1024-239x3001

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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Upbeat Burt team pub on stem cells for MS comes with uneasy back story

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Stem cells for MS, Types-of-Multiple-Sclerosis

Stem cells for MS? How promising is that? A new paper gives stronger reason for hope, but unfortunately this story is more complex than it seems on first glance. New Paper The idea of using a stem cell-related approach to treat multiple sclerosis (MS) has been around for a long time holding major promise, but

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When the state & ‘rogue’ scientists collide: case of China & CRISPR baby guy He Jiankui (贺建奎)

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He-Jiankui-贺建奎

What happens next to He Jiankui (贺建奎) or as some people now refer to him, the “CRISPR baby guy”? China has a challenging situation to resolve here, but such conflicts between scientists and governments have happened regularly in history. When scientists go “rogue” (i.e. don’t conform to norms or ethical standards in an extreme way or

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

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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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Stem cell eye drops? Skepticism of American Academy of Stem Cell Physicians (AASCP)

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AAOSCP-meeting

What is the AASCP? I’ve been hearing more recently about something called the American Academy of Stem Cell Physicians (variously AAOSCP or AASCP). Its name has the sound of an organization like some traditional medical academy such as the American Academy of Internal Medicine, but my sense is that this is a totally different kind

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