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Tag: US Stem Cells

Chaos, Unfairness and Illegality in the US Stem Cell Case

Chaos, Unfairness and Illegality in the US Stem Cell Case

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I have been following and writing about the US Stem case (and the FDA’s parallel California case) since the company received its warning letter and throughout the litigation. Last month, the judge issued the final injunction order. Here it is: permanentinjunctionorder The order, among other things, mandates the destruction of all SVF product in the defendants’ possession, which destruction is to be supervised by the FDA. (page 9, paragraph 10) That caught me by surprise. I might have missed something…

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US Stem Cell Case Update: Judge Puts off Pre-Trial Conference for Three Weeks

US Stem Cell Case Update: Judge Puts off Pre-Trial Conference for Three Weeks

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Yesterday, May 9th, the Judge in the FDA’s case against US Stem Cell and Kristin Comella entered an order changing the pre-trial conference date from May 17th until June 10th. The trial has been pushed back from June 10th until June 24th. Why: The obvious reason is that she hasn’t finished her decision on the parties’ cross motions for summary judgment, and there’s no point having a pre-trial conference with summary judgment motions pending. So, she’s giving herself another couple…

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Some things in the private stem cell clinic debate are complicated, but some aren’t

Some things in the private stem cell clinic debate are complicated, but some aren’t

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I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action. But I don’t. I just can’t get past the fact that this Florida stem cell operation allowed a nurse practitioner to inject stem cells into several patients’ eyeballs which resulted in total or partial blindness. A nurse practitioner! Legal though it may have…

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Further thoughts on the defendants in the FDA’s stem cell injunction actions

Further thoughts on the defendants in the FDA’s stem cell injunction actions

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My post about considerations facing the defendants in the FDA’s injunction cases, http://rickjaffeesq.com/2018/05/17/hard-choices-stem-cell- defendants-fdas-injunction-cases/ was discussed yesterday in the stem cell field’s big dog, the Niche, by Paul Knoepfler. https://ipscell.com/2018/05/when-the-fat-stem-cells-hit-the-fire-will-clinics-sued-by-fda-opt-to-stop-soon/. After reading it, a follow-up is in order. A correction and follow up: In my post, I said that both US Stem Cell and California Stem Cell Treatment Center had received warning letters. Knoepfler correctly pointed out that the California company had not received a warning letter from the FDA,…

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