AST-OPC1

Mesoblast gets FDA RMAT; List of 10 total designations so far

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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 …

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Stem cell good news: Spinal Cord Injury Trial, CIRM, Grants, & More

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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 …

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Good stem cell news on trials, FDA, cool new papers & more

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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 …

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Asterias interview: stem cell spinal cord injury trials advance

Asterias

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 …

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Early, but encouraging data from Asterias on stem cells for spinal cord injury

Asterias

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 …

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Interview with Jane Lebkowski on Asterias FDA-approved Stem Cell Trial

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The BioTime subsidiary, Asterias, has received FDA approval for a combined Phase I/IIa clinical trial of OPC1 for treating spinal cord injury. BioTime (BTX) and Asterias (ASTY) have picked up the portfolio of the former Geron clinical trial using oligodendrocyte precursor cells (OPC). Asterias also acquired a second element from Geron in the form of a lung …

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