It’s notable how the FDA now considers gene-editing a kind of regenerative medicine. This means that various gene therapy products in development technically qualify as regenerative therapies. Ever since the agency began its rapidly growing regenerative medicine advanced therapy (RMAT) designation program, we’ve seen an increasing number of gene therapy biotechs and products qualify as RMATs. As a result, the RMAT-qualified gene therapies get to go into a speedier lane of FDA oversight. Today’s post is a mix of recommended reads in the regenerative …Read More
iPS cells
Over time I seem to collect more upbeat stories about stem cells and regenerative medicine as well as cool publications so today’s “good news” post is a collection of these kinds of things plus one example of huge science hype. Here’s a list of past such upbeat posts. The preclinical good news in rats from my graduate alma mater UCSD, ‘New Injection Technique May Boost Spinal Cord Injury Repair Efforts‘ via stem cells. Here’s the actual Stem Cells Translational Medicine pub.from a team led …Read More
Where do things stand today in 2020 with IPS cell research? It’s been 14 years since they were first reported, but they continue to make news. Back in 2006 I was wrapping up my postdoc with Bob Eisenman at The Hutch in Seattle, largely studying Myc, when Shinya Yamanaka published his first induced pluripotent stem cell (IPS cell) paper in Cell. For me it was one of those amazing moments reading a pub when you just go “wow!” Now all these years later we …Read More
The stem cell universe is populated by sometimes mysterious acronyms (see an image of a whole alphabet stem cell acronym soup), many of which refer to specific kinds of stem cells including one nebulous type called MUSE cells. I’m not convinced that MUSE cells exist, but oddly there appear to be four clinical trials ongoing in Japan based on MUSE cells. So somebody believes in them. Is the clinical work using MUSE cells in Japan allowed because of the more permissive regenerative medicine regulatory …Read More