January 16, 2021

The Niche

Trusted stem cell blog & resources

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

3 min read

In December of each year I make a list of stem cell predictions for the coming year, and I made 20 such predictions for 2017 so I’m wondering how I’m doing so far on these now that it’s June. Below is my work-in-progress scorecard for these so far. Positive news from Asterias on trial for stem cell-based therapy for spinal cord injury. Status: Correct, trial looking encouraging. Upbeat news from ViaCyte on stem cell-based therapy trial for diabetes. Status: Correct, raising $10M and things looking promising. More positive news …Read More

1 min read

Enjoy! A Sunday brunch for the brain of science news, helpful links, and notable new papers including on stem cells. News and links CBER Director Focuses on Flexibility to Advance Regenerative Medicines Lab-Grown Blood Stem Cells Produced at Last Transplanted stem cells become eggs in sterile mice Maryland fund awards $8.5 million for stem cell research Positively good news from Asterias for CIRM-funded stem cell clinical trial for spinal cord injury Sergio Canavero: Will His Head Transplants Roll? Century-old tumours offer rare cancer clues Papers Identification of hair shaft progenitors that …Read More

2 min read

Over at the California Stem Cell Report, David Jensen is reporting on some good news from CIRM for California on the stem cell clinical trial front. Stem cell biotechs Asterias and Capricor have stem cell trials supported by 20+ million in CIRM funding each and have been hitting milestones. These trials are progressing and so far have good safety profiles. Asterias and CIRM have mentioned some possibly encouraging early hints at efficacy as well in its trial, and apparently there are hopeful hints from the Capricor trial too. See …Read More

2 min read

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile and additional hints at possible positive indicators of efficacy. With the usual, important caveats such as that this is early and it is not an RCT, the SCiStar momentum …Read More

3 min read

Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions. You can see below links to these predictions for past years, which sometimes seems rather far removed from today and in other cases strike me as strangely apropos of …Read More

6 min read

Recently I had the opportunity to talk with the leadership of Asterias, a California biotech doing exciting clinical research using stem cells as the basis for treatment of spinal cord injury. The interview covers the past (Geron patients), present, and future. I spoke with Asterias President and CEO Stephen Cartt and CMO Edward Wirth. How are the Geron patients doing? Asterias: They are doing well. We have to remember that they got the low dose (2 million OPC1 cells) and we estimated that an …Read More