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
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
There has been a lot of excitement this week about a press release from stem cell biotech Athersys that reported that treatment of stroke patients with its product MultiStem was associated with a statistically significant improvement at 1-year. This sounds encouraging and the stock has spiked up as a result. However, there are some naysayers including long-time stem cell biotech critic Adam Feuerstein, who today painted the Athersys press release as little more than spin. Feuerstein went through a list of what he describes …Read More
What is the most exciting, important, promising, all-around awesome stem cell biotech of 2014? Vote and tell us why in the comments.
What are the most interesting questions for the stem cell field in 2014 right now? What’s on your mind? I’m not going to give this deep thought, but rather just list those questions bouncing around at the moment in no particular order. You can see a lot of translational/clinical things are on my mind. I’ve put possible answers, but these are highly speculative and/or based on hope in some cases. What’s next for ACT’s hESC-based clinical trials and Takahashi’s iPS cell-based clinical study for macular …Read More
The below is an excerpt from my book, Stem Cells: An Insider’s Guide. I hope you enjoy this excerpt and the book, which I think is a really good deal at under $27 paperback or under $17 for E-book version. Having our innovation and ethics too In the stem cell field you can have it both ways. As a company, you can be ethical and help patients. There are many examples of stem cell-related corporations doing “the right thing” when it comes to developing …Read More