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

December 26, 2017 / Professor Paul Knoepfler, Ph.D. / 13 Comments

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

August 27, 2017 / Professor Paul Knoepfler, Ph.D. / 2 Comments

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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Stem cell biotech bites: Mesoblast, BioTime, MS, FDA Warning, & More

June 14, 2016 / Professor Paul Knoepfler, Ph.D. / 4 Comments

Stem cell studies continue to make big news with a mixed bag of trends including for stem cell biotech, and some good stem cell news and others not so much. Mesoblast ($MESO) had its stock suspended for quite so time recently in anticipation of a big announcement. When that news came today it was discouraging in

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Mesoblast stock on hold: Poll if you expect good or bad news

June 6, 2016 / Professor Paul Knoepfler, Ph.D.

Adult stem cell biotech Mesoblast ($MESO) is in the unusual situation currently of having its stock on hold. This is a relatively rare event and usually portends some kind of major news. The hold is expected to run from June 1 to June 10. Mesoblast will announce ““material corporate developments with respect to certain assets

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Mesoblast (MSB) buys Osiris (OSIR) stem cell unit

October 11, 2013 / Professor Paul Knoepfler, Ph.D. / 1 Comment

The Australian stem cell biotech Mesoblast (MSB) has reportedly reached a deal with the American stem cell biotech Osiris (OSIR) to buy Osiris’ mesenchymal stem cell (MSC) unit. This is a big development in the MSC field. Osiris and Mesoblast are two major players in this particular subfield of the stem cell world so this deal,

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Viacyte & Mesoblast present at CIRM Meeting

March 7, 2013 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Allan Robins of Viacyte (pictured at left–sorry for the fuzzy image) and Paul Simmons of Mesoblast presented this morning at the CIRM Grantee Meeting. Both talks were outstanding. Robins went first. He started by saying how Viacyte had a productive pre-IND meeting with the FDA last year. I believe a target for them is to

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Recent stem cell & regenerative medicine good news

April 30, 2024 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Looking for some stem cell good news? You’ll like today’s post. One mission of this blog The Niche is to promote rigorous science-based regenerative medicine, which can lead to investigating and writing about not-so-upbeat stuff. Risky clinics. People getting hurt. Patient lawsuits. Serious FDA, FTC, or state AG regulatory developments. Such actions can be good

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20 stem cell & regenerative medicine predictions for 2024

January 3, 2024 / Professor Paul Knoepfler, Ph.D. / 4 Comments

Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024. You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please

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2023 stem cell predictions grades reflect wild year for regenerative medicine

December 27, 2023 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Every year I make stem cell and regenerative medicine predictions. Looking at my predictions for 2023, they reflect a wild year but in many ways a good one overall. Below I have graded my 2023 predictions. Overall, my crystal ball gave solid results. Some of the predictions have been condensed to keep things concise, but you

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3 cell therapy companies doing well: Vertex, Vericel, & Regeneron

November 15, 2023 / Professor Paul Knoepfler, Ph.D. / 5 Comments

Cell therapy companies face many hurdles. I wrote recently about four cell therapy biotechs that have been really struggling. Blogging here at The Niche for more than a dozen years, I’ve seen many companies even go under. That’s bad news for the field, for patients, and for investors. Today I wanted to highlight some cell therapy

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