Cynata Therapeutics Limited has received approval from UK regulators to start a first-of-its-kind allogeneic IPSC-based trial of MSCs for graft versus host disease (GVHD). Cynata also had some big news a couple weeks back with a deal with Fujifilm. The company is aiming to recruit 16 patients to test whether the MSCs (a type of adult […]
Cynata approval for 1st ever allo trial of IPSC-derived MSCs for GVHD Read More »
KPBS reporter David Wagner has an important new piece out today on for-profit investigational stem cell treatments and he focuses to a large extent on a stem cell business in San Diego called Stemedica. If you’ve heard of this company it might be in part because they were involved in the Gordie Howe stem cells for stroke story that got
KPBS sheds new light on Jim Gass stem cell case, Stemedica Read More »
In the total the FDA has held 3 days of public meetings on stem cells in the last few weeks ranging from science to policy and hearing from many parties including patients and even stem cell clinics so the big question now is, “what happens next?” The FDA has 4 draft guidances pertaining to investigational
What happens next with FDA & stem cells: lower your expectations? Read More »
What does Google think (if Google does indeed think) are top 10 stem cell news stories right now? I took a screen shot below. Here are some thoughts on those stories. First, lung organoids are neat, but they have been grown before by several groups. Why is that the top story? I’d have to ask Google. Better
Google Stem Cell News Stories: Perspectives Read More »
As I posted recently, Asterias Biotherapeutics has had good early safety results so far in its historic stem cell trial for spinal cord injury and now the company presented some early, encouraging hints at efficacy. However, a caveat here is that this is not an RCT (randomized controlled trial). Ed Wirth, CMO of Asterias, presented the
Early, but encouraging data from Asterias on stem cells for spinal cord injury Read More »
By Jeanne Loring Paul did a good job of giving an overview of the FDA meeting today. Being in the room, I have a few observations that complement Paul’s. I’ve never been to a meeting like this- there were 42 scheduled 5 minute presentations, and this is just the first of 2 days. The question
Jeanne Loring’s Report from Inside FDA Stem Cell Meeting Day 1 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.
8 key arguments, take-homes on day 1 of FDA stem cell meeting 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
Guide to September 12-13 FDA Stem Cell Meeting Read More »
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 »