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Long-term hope on stem cells for deafness

stem cells for deafness

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 …

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FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

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 …

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Updated FDA granted RMAT List (85)

FDA-RMAT

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 …

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

Mesoblast-e1514313188176

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

Jan-Nolta-stem-cell-good-news-2

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 …

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Stem cell therapy review of good news: UC Davis, Asterias, Cynata, Mesoblast, ViaCyte

VC-01-post-implant-final1-e1503703572933, viacyte

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 …

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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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Stem cell good news as Asterias SCI trial to expand with strong safety data

Jake-Javier-CIRM-Photo

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 …

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