Search Results for: comella

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

February 1, 2021 / By / 9 Comments
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 clinic experimenting on patients with unapproved genetically modified ‘cancer vaccine’?

February 1, 2021 / By / 8 Comments
USRM-stem-cell-meeting-video

What if it seemed based on the public statements of its leader that a business was using an unapproved and unproven, genetically-modified, stem cell-based ‘cancer vaccine’ on patients? Is that possible? Sometimes I think I’ve seen and heard it all when it comes to companies marketing non-FDA approved, scientifically unproven stem cell ‘therapies’ to patients …

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New stem cell clinic insights from trio of critical media pieces

February 1, 2021 / By / 2 Comments
US-Stem-Cell-Clinic-video

Three recent media pieces on unproven, for-profit stem cell clinics paint an unflattering picture of this industry. At the intersection of these pieces is the clinic “treatment” consisting of fat stem cells (being manufactured as in a screenshot at right from a clinic YouTube video), a product the FDA has indicated is most often going …

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

February 1, 2021 / By / 16 Comments
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

May 12, 2023 / By / 4 Comments
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

February 1, 2021 / By / 7 Comments
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?

February 1, 2021 / By / 5 Comments
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

September 14, 2023 / By / 11 Comments
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

May 12, 2023 / By / 3 Comments
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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