Search Results for: Kristin comella

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

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

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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Six questions as FDA takes new shot at stem cell clinics

FDA-draft-guidance

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already …

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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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NEJM paper links 3 blinded patients to US Stem Cell clinic

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

Do three blinded US 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 …

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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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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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My take as a biologist on US Stem Cell “natural” claim in federal court case endgame

SVF2

It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains …

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