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”. […]
Negative stem cell clinic outcomes include 3 blinded women Read More »
The FDA is holding its first 2016 stem cell meeting today and you can read about some impressions of the morning session of this meeting here. In this post, I’m focusing on the afternoon session, which has been mostly on policy and ethics, including on stem cell clinics. Jonathan Kimmelman from McGill University got the afternoon going
Blogging today’s FDA stem cell meeting: Part 2 Clinics, Policy & Ethics 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
Blogging today’s FDA stem cell meeting: Part 1 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
For big FDA stem cell meeting, are clinics paying some participants? Read More »
There’s a big FDA stem cell meeting coming along next week that has gotten much attention, but many people didn’t realize there’s also an FDA meeting on stem cells this week too in three days on September 8th. I pasted this week’s meeting schedule at the bottom of this post from the FDA page. The meeting is
Wait, there’s an FDA stem cell meeting this week too? The scoop Read More »
Here is a hub for 2017 stem cell and regenerative medicine meetings. If you do not see your meeting, please let me know and I will include it. Change– I’m also going to be listing online courses (in red) this year. This list is meant to be as inclusive as possible, but by listing specific
Stem Cell Meetings & Conferences 2017 Read More »
The stem cell clinic trial being run by Asterias Biotherapeutics for spinal cord injury (SCI) reported (via CIRM) some preliminary very good news as it is so far seems safe and will be expanded to involve more patients. In the next phase, reportedly “Asterias is now looking to enroll 5-8 patients for this 20 million
Stem cell good news as Asterias SCI trial to expand with strong safety data Read More »
I’ll be on NPR’s @hereandnow w/Robin Young in about 40 minutes talking stem cell clinics. #Stemcell clinics thrive in US despite lack of @US_FDA regs. Is it #SnakeOil? @Pknoepfler thinks so. https://t.co/NxJ5z3IVGw @hereandnow — Karyn Miller-Medzon (@KBMM) September 1, 2016 Listen in if you have the chance and the segment will also be archived on
I’m on NPR’s Here & Now Talking Stem Cell Clinics in ~40 minutes Read More »
The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which
FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics? Read More »
Journalist Melinda Beck has a new piece on fat stem cell clinics in the Wall Street Journal (WSJ) today that includes one very brief quote from me that I believe effectively ends up being an unintentional misquote because of a lack of context. Here in this blog piece I want to provide that important missing
Providing key context for my quote in WSJ on fat stem cell clinics Read More »