Search Results for: stem cell clinics

Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

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FDA

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest […]

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

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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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R3 Stem Cell still raises red flags for me after FDA letter including do one-get one meeting

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R3-Stem-Cell-Course

Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. FDA and R3 Stem Cell While the FDA didn’t send R3 Stem Cell a formal warning

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If you’ve had a stem cell therapy, how was your experience?

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stem-cell-treatments

Over the years I’ve asked patients to talk about their experiences getting a stem cell therapy. One particular post in 2016 has drawn almost 400 comments, many from patients. The insights provided by these patients and the questions asked in the comment stream have provided a unique window into what’s going on out there. There

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Journal erred on Panama clinic stem cell for autism paper

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The-Stem-Cell-Institute-stem-cells-for-autism, Panama Stem Cell

Amongst all that is bouncing around within the stem cell clinic maelstrom out there, one thing stands out for me as the most troubling. I’m talking about for-profit experimentation on children, such as injection of kids with unproven stem cells for autism or cerebral palsy by unproven clinics. In my opinion it’s almost always going

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StemGenex clinic bankruptcy reveals surprises including huge revenue

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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

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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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Kristin Comella resigns from embattled clinic firm US Stem Cell

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Kristin-Comella

US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to

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