Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. While the FDA didn’t send R3 Stem Cell a formal warning letter, in my view the agency made it very clear in the “untitled” letter that this firm should make some changes. The letter went out both to R3 Stem Cell and its dozens of …Read More
Does it make any sense scientifically or medically to use stem cells for pain? I’m skeptical in most cases today. The whole idea of stem cells for pain has been on my mind for a number of reasons. For one thing, more stem cell clinics are marketing unproven stem cell therapies at a high price specifically for pain relief lately. People are even having conferences on this concept. See the email ad I got yesterday on one such conference below Is there any FDA-approved stem …Read More
Today was the first part of the FDA’s 2-day meeting on stem cell draft guidances. It was a great meeting I thought. A few consistent themes and notable things emerged as raised by participants.
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.
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 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.
Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to reach out to the FDA to clarify the process. PK: When the FDA issues draft guidances is it a standard approach to have a public meeting of the kind …Read More
Below is a list of upcoming stem cell and regenerative medicine conferences and meetings for 2016. You can see the meeting list for 2020 here. The new year has a lot to offer in our field. If you do not see your meeting, please let me know and I will include it. This list is meant to be as inclusive as possible, but by listing specific events I am not necessarily endorsing them. January Molecular and Cellular Basis of Growth and Regeneration (A3) January …Read More
By Heather Main This year I will be attending the World Stem Cell Summit for the first time (see @WSCSummit on Twitter). I was surprised when I looked at the program and recognized so few of the names of speakers; which made me question what this event was about, if not focused on stem cell research. This was a relatively naïve step from someone who has spent their entire academic career working on mouse embryonic stem cells and attending academic-focused conferences, far away from human …Read More
Dr. Christopher Fasano, principal investigator at the Neural Stem Cell Institute and creator and host of THE Stem Cell Podcast founded a unique stem cell meeting in 2013. In this short interview I find out about The Next-Gen Stem Cell Conference (to be held this year on May 6-7) and how it differs from the others. What is the Next-Gen Stem Cell Conference? The Next-Gen Stem Cell Conference is a meeting where young stem cell scientist get together in a causal setting to exchange …Read More