Search Results for: warning letter

When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon?

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when-the-fat-hits-the-fire-stem-cells

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? […]

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Helpful Zettler insights from Q&A on FDA suits against stem cell clinics

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Patti-Zettler

At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it

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

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Kristin-Comella1

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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US-Stem-Cell-Clinic

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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Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women

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stem-cells-eyes, stem cell therapy side effects.

Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months

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

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Peter-Marks-Scott-Gottlieb-FDA

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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Why did Texas A&M ink big deal with stem cell clinic firm Celltex on exosomes?

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Texas-AM-Celltex-deal

The recent news that Texas A&M University has inked a full-blown deal with the direct-to-consumer stem cell clinic firm Celltex struck me as an unusual development. Recently we’ve seen more universities exploring the use of stem cells outside of the traditional FDA clinical trial process that is fundamentally based on an investigational new drug application (IND). Some

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20 predictions for stem cells & regenerative medicine in 2018

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stem-cell-crystal-ball-300x3001

Every year I look into my stem cell crystal ball and make predictions for our field including regenerative medicine. Well, I don’t really look into a crystal ball, but I try to use a combination of what I’m hearing through the grapevine, stuff I’m reading, some info that is not yet in the public domain,

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New lawsuit against U.S. Stem Cell also alleges blindness

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stem-cells-eyes, stem cell therapy side effects.

A new stem cell clinic lawsuit has popped up and this one, like some others, relates to a patient alleging vision loss due to a non-FDA approved stem cell offering and involves U.S. Stem Cell, Inc. (formerly called Bioheart). American stem cell clinics market direct-to-consumer stem cell offerings for a whole medical dictionary’s worth of

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