October 21, 2020

The Niche

Knoepfler lab stem cell blog

Asterias

4 min read

Back in 2013, a half dozen years ago, I went out on a limb and made predictions for the stem cell field for 2020. These are different than my yearly predictions for the coming year (for instance, you can see my predictions made in 2018 for this year of 2019 here). As to my 2013 predictions, of course, it’s only 2019 and not yet 2020, but how are my old predictions looking at this point? I can’t be sure how they’ll look next year …Read More

3 min read

Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting on the Mesa in October, an FDA official reportedly presented data indicating that about 1/3 applications for RMATs were granted (see image below from Twitter). This recently announced RMAT …Read More

3 min read

Stem cell good news time…and more will be coming later this week. The stem cell and regenerative medicine world sometimes feels chaotic because so much is going on both on the positive and negative sides of things. There is a whirlwind of activity and developments, and a tendency sometimes within our arena to just avoid bad or complicated news. One mission of this blog is to try to cover the full spectrum of developments including difficult situations, but I also want to focus in …Read More

3 min read

It’s a difficult, but very important road to conclusively prove that an investigational stem cell therapy is both safe and effective in order to get final approval FDA or equivalents in other countries. For this reason, it is beneficial to highlight even small, but positive steps forward including encouraging pre-clinical data. Today I’m doing a review of stem cell therapy good news in the clinical path with a focus on biotechs in particular (in alphabetical order), but starting first with news from here at …Read More