Search Results for: warning letter

Liveyon is back (again) with unproven exosome product

Liveyon

Remember our old friends Liveyon? Their leader John Kosolcharoen? Liveyon’s continuing metamorphosis This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. That stem cell thrust ultimately landed a dozen or more people in the hospital as […]

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Mystery of wild sci-fi film ad for unproven exosomes: Liveyon?

awakening-exosome-film-ad

What’s Liveyon up to these days? A new, somewhat mysterious short film that serves as an advertisement for unproven exosomes has some of us scratching our heads. It seems to point to Liveyon. Can you guys as readers of The Niche help solve the puzzle of who’s behind this wild “cinematic commercial” and what the

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20/20 vision? The Niche’s 20 stem cell & regenerative medicine predictions for 2020

The-Niche-stem-cell-predictions-2020

Every year in December and early January I do a post predicting some key events for the stem cell and regenerative medicine field for the upcoming year and today’s post contains my predictions for 2020. You can see my past 2019 predictions along with my grades for them here. I gave myself a B+ for

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B+ on my report card on my 20 stem cell predictions for 2019

stem-cell-crystal-ball-predictions-1

Last year around this time I took my annual plunge to make 20 predictions for the coming year for the stem cell and regenerative medicine field. I even made a crystal ball graphic to highlight the complexity of the stem cell ecosystem into which these predictions were embedded (see image) for 2019. How’d I do?

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Why did clinic supplier Liveyon halt sales but others kept going despite FDA?

Liveyon-reincarnated

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in

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Bad Batch podcast’s dark picture of perinatal stem cell industry

John Kosolcharoen, Liveyon

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have

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Report from Medical Board of California meeting on stem cell clinics

Dr.-Charity-Dean-California-Med-Board-stem-cell-clinics

This afternoon I attended and gave public comment at the Medical Board of California stem cell task force meeting on unproven stem cell clinics. There were about 40 people attending. In part this meeting is a consequence of the national governing organization of state medical boards, the Federation of State Medical Boards (FSMB) having worked

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StemGenex clinic bankruptcy reveals surprises including huge revenue

Stemgenex

How much money and how many patients do stem cell clinics like San Diego’s StemGenex make each year? A new court document has some insights from an unexpected angle. I’ve been following StemGenex for years here on The Niche. It’s been a rollercoaster ride. Things hit a new low today, perhaps marking the operational end

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FDA warns another perinatal stem cell supplier Stemell

Stemell-logo

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain

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Northwestern abruptly ending Burt HSCT autoimmune trials

Selma-Blair-HSCT

“HSCT Chicago Clinic Closing!” is the startling header in all caps on a patient-run Facebook page about a stem cell therapy clinical trial program at Northwestern University. What’s going on? Unfortunately, the promising field of hematopoietic stem cell transplantation (HSCT) for multiple sclerosis (MS) and other autoimmune diseases seems to have suffered an unexpected setback

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