A reader of The Niche recently asked me, “What about stem cells for deafness?” It’s a great question and, as they pointed out, stem cells for vision loss gets much more attention. I’ve covered the translational progress of stem cells to treat many diseases but there has been less progress for deafness in the regenerative […]
Long-term hope on stem cells for deafness Read More »
This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »
Today’s post includes a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. Sometimes people call these “r mat” with a space. As of December 12, 2023 there are 85 RMATs in the public domain. I also include FDA data on RMAT submissions via an FDA RMAT resource
Updated FDA granted RMAT List (85) Read More »
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
Mesoblast gets FDA RMAT; List of 10 total designations so far Read More »
Stem cell good news time and more will be coming later this week. The stem cell and regenerative medicine world sometimes feels chaotic. Why? 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
Stem cell good news: Spinal Cord Injury Trial, CIRM, Grants, & More Read More »
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
Stem cell therapy review of good news: UC Davis, Asterias, Cynata, Mesoblast, ViaCyte Read More »
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
Asterias interview: stem cell spinal cord injury trials advance 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 »
The stem cell clinic trial being run by Asterias Biotherapeutics for spinal cord injury (SCI) reported (via CIRM) some preliminary very good news as it is so far seems safe and will be expanded to involve more patients. In the next phase, reportedly “Asterias is now looking to enroll 5-8 patients for this 20 million
Stem cell good news as Asterias SCI trial to expand with strong safety data Read More »
A lot has happened in 2014 in the stem cell and regenerative medicine field and so much of it has been good news so let’s focus on the positive. These positive developments are often the result of many years of creative, hard work by amazing teams of researchers. Here is my top 10 list of
Positive Stem Cell Developments in 2014 Read More »