US Stem Cell

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

Eye-injection-e1478306814439

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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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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US Stem Cell Clinic sues anonymous critics for libel, seeks IDs from websites

stem cell stocks

Last month the stem cell community learned that a patient of the business US Stem Cell Inc./US Stem Cell Clinic, previously known as Bioheart, had filed suit in a Broward County Florida Court against the publicly traded company alleging various charges including damage to her eye. Now US Stem Cell has more recently filed suit in the …

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