FDA stem cell meeting

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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Rick Perry’s Paid Board Position at Controversial Stem Cell Clinic Celltex

Perry-Scripps

If you rewind the stem cell clock several years, the big news in the stem cell clinic arena was dominated for quite some time by a single stem cell clinic called Celltex in Texas in part because their most famous customer was Governor (at that time) Rick Perry. You can read the many past posts I’ve …

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Report on day 2 of FDA stem cell meeting: patients, researchers, & more

FDA-stem-cell-meeting-day-2

The FDA’s stem cell meeting wrapped up today on day two with a diverse group of individual speakers. A series of patient testimonials today in favor of clinics was one thing that stood out. You can read my take of day one and the account of Jeanne Loring who was at the meeting. I’ve noted that on …

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Guide to September 12-13 FDA Stem Cell Meeting

Stembucks

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have …

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Negative stem cell clinic outcomes include 3 blinded women

Michael-Miller-MD-PhD-e1473364751156

What can go wrong with unapproved stem cell clinic offerings? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S. Thomas Albini, MD gave a talk entitled,  “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”. …

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Blogging today’s FDA stem cell meeting: Part 1

FDA-stem-cells

The FDA is holding its first 2016 stem cell meeting today. How’s the meeting going? The meeting start awfully early for us West Coast folks (5:30am) so I didn’t get to see the first few talks. Did anyone else see those and if so, what was your impression? From the talks I have seen, this meeting …

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For big FDA stem cell meeting, are clinics paying some participants?

stem-money

The upcoming big FDA 2-day public stem cell meeting next week is generating a lot of interest within the stem cell community and also with members of the media. I expect there to be tons of coverage, which should be a good thing (note that there’s a different FDA stem cell meeting tomorrow). If you can’t make …

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Outcome of FDA stem cell meeting likely to please no one

FDA-draft-guidance

It’s been a big 2 weeks in terms of media interest in talking about the upcoming FDA meeting on stem cell oversight taking place in just a few weeks. There are many questions about this meeting and I’m planning to tackle some of the questions in upcoming posts including next week. These questions include, “who …

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September FDA stem cell meeting looks to be big debate

FDA-draft-guidance

That much-anticipated public FDA stem cell meeting that was postponed from April will now take place in September and will have a much larger array of diverse speakers. Many more voices at an FDA stem cell meeting are collectively a good thing, but delay is not. The large and growing U.S. stem cell clinic industry makes …

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