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 cell business in Florida called U.S. Stem Cell, Inc. was sued along with other defendants by a former customer Elizabeth Noble, alleging harm done via an experimental stem cell “treatment” …Read More
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 done on Celltex here. Today the stem cell clinics are making news more for their sheer numbers (nearly 600 in the U.S. alone), but a few years back Celltex …Read More
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 average about 350 people were watching the webcast of the meeting both days. The patients gave powerful, often emotional testimonials today on their experiences at various stem cell clinics …Read More
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 a satirical cartoon from some time ago I drew imagining such a future.
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”. Stem cell clinic transplants of fat stem cells led to blindness in three women, reported Dr. Albini. We’ve heard encouraging news about how stem cells might help patients regain …Read More
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 is very scientifically focused so far. There has been a lot of clinical trial data presented, which for me as a scientist I really appreciate. We’ve heard about promise, …Read More
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 tomorrow’s stem cell meeting in person and it is now closed to additional in-person participants, you can watch the webcast here. Amongst the many speakers on the agenda for next …Read More
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 are the specific individuals attending and what are their perspectives?” What exactly are all the organizations that are on the agenda and what are they going to say? Another …Read More
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 it ever more important for the FDA to move forward quickly with clearer and more definitive guidelines on clinical use of stem cells. At the same time those investigators …Read More
The FDA stem cell meeting that was supposed to take place in April is now officially going to be a 2-day event in September. This public meeting is meant to get comments on four draft guidances related to regs on stem cell products and treatments.