Bioheart

Kristin Comella resigns from embattled clinic firm US Stem Cell

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

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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Stem cell fake news driving biotech investors or vice versa…or what?

US-Stem-Cell-Google-Search-e1495552962354

Is there a proliferating stem cell fake news problem in the biotech world? More broadly, the SEC is cracking down on the mess that is fake biotech news, but what about fake news on stem cell biotechs more specifically? Already in the past year I’ve seen examples of possible stem cell fake news. Hyped press releases (PR) …

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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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NEJM paper links 3 blinded patients to publicly-traded stem cell clinic

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

Do 3 blinded stem cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image from a …

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Grading my stem cell predictions for 2016: how’d I do?

stem-cell-predictions

Below are the 2016 stem cell predictions I made last year and their status now color-coded near year’s end. Green is right, orange is mixed bag, and red is flat out wrong. Overall, I did better than most past years with only having entirely blown it on four. Stay tuned later this week for my 2017 predictions, …

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2nd lawsuit alleging a U.S. stem cell clinic caused blindness

Hollywood-Eye-Institute

Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients. What are the concerns? Earlier this year a publicly-traded stem …

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Muddier stem cell waters: Stemedica teams up with UCSD doc?

stemedica

Stemedica announced it is teaming up with UC San Diego (UCSD) to do stem cell research. This fits with an increasing trend in the stem cell arena is the teaming up of clinical partners with very different backgrounds and priorities. For instance, academic institutions are more often working together with for-profit stem cell clinics. Another branch …

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