US Stem Cell Inc.

Wouldn’t you like to be a RAT too? Stem cell clinics apply for new FDA accelerated approval path

RAT-RMAT-designation

Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some …

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SCOTS, Selling Stem Cells, & More Patient Claims of Blindness

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Have more patients been blinded by stem cell clinics? The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning of information beginning to flow on negative outcomes for patients who are customers of stem cell clinics selling non-FDA approved offerings. The NEJM authors linked the loss of vision to interventions received …

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Does stem cell clinic IRB approval mean much? Insights from blinding cases

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

Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)? More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it …

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Update on patients lawsuit against stem cell clinic, Stemgenex

Stemgenex

The website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex.  Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case …

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Stem cell checkup: how are my 2016 predictions doing half way?

Stem-Cell-Predictions

Each December I make stem cell predictions for the coming year and I did that for 2016 where I made 20 predictions. At around mid year I do a checkup on how my predictions are doing halfway and that is the purpose of this post. Below are my predictions that I made in 2015 for stem …

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