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Hoping for approval, Mesoblast says FDA wants new remestemcel-L trial

August 3, 2023 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Australian biotech Mesoblast has had a rollercoaster ride working toward FDA approval of its mesenchymal cell therapy product remestemcel-L. They are seeking approval for use in patients with graft-versus-host disease (GvHD). More specifically, it is intended for pediatric patients with steroid-refractory acute graft versus host disease, or SR-aGVHD. This is a serious condition and new treatment […]

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Lessons from 4 stem cell stocks that tanked: Celularity, Athersys, Mesoblast, BrainStorm Cell

October 3, 2023 / Professor Paul Knoepfler, Ph.D. / 11 Comments

Athersys stock, Athersys, stem cell stocks

I’ve been following 24 stem cell stocks for a few years. I haven’t invested in them or any others recently, but rather just find them interesting. How are these doing in 2023? Mostly not great. In some cases, it is downright disastrous. Let’s take a quick look at four stocks very much in the news over

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Weekly reads: BioCardia, HeLa suit, illegal bio lab in CA

August 6, 2023 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

A days ago the news came about Mesoblast not getting FDA approval for its MSC product for GvHD. The MSC area has had a rough few years with various clinical trials including for COVID. The “stem cells for heart disease” arena has also had a tough time. Here’s more news along these lines: BioCardia pauses enrollment in PhIII trial

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Weekly reads: big CRISPR mtg, Mesoblast good news, Neuralink spiked

March 12, 2023 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Where do things stand with potential applications of CRISPR and other gene editing technologies in patients? Overall, things are looking very positive. CRISPR human trials This week the third big international human genome editing meeting took place in London. The summit addressed numerous potential clinical applications. It was good to see the agenda included quite

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Stem cell therapy: the good, the bad, & the muddy waters

July 20, 2021 / Professor Paul Knoepfler, Ph.D. / 7 Comments

How can you tell who to trust in the world of stem cell therapy? What information can a patient trust? Once upon a time about a dozen years ago it seemed a much simpler question. There were universities and biotech companies doing legit research as well as clinical trials, and there were physicians doing bone

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Mesoblast stock hit on gloomy data on stem cells for COVID-19

December 22, 2020 / Professor Paul Knoepfler, Ph.D. / 3 Comments

I’ve been closely following the arena of stem cells for COVID-19 since the pandemic broke including the efforts of Mesoblast. Mesoblast unlikely to meet primary endpoints in Phase III COVID trial Now, the firm got bad news as its DSMB reported that they are unlikely to meet the primary endpoint for their Phase III trial

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Weekend cell biology reads: Mesoblast COVID-19 deal, pubs

November 22, 2020 / Professor Paul Knoepfler, Ph.D. / 5 Comments

bergert cell stem cell 2020 cell mechanics sm

The COVID-19 pandemic is tearing through the country right as we are starting into the holiday season, but the wheels of science including cell biology keep going and we keep reading all the great work. What news or papers caught your eye? Here are some of the things I have on my list of reading.

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Mesoblast MSCs Quell Peds GvHD; On Road to FDA Approval?

August 20, 2020 / Ricki Lewis / 6 Comments

MSCs-mesenchymal-stem-cells-stromal-cells-small

Graft-versus-host disease (GVHD) is counterintuitive In the weeks and months following a transplant, a major concern is the recipient’s immune system rejecting the “foreign” biological material. But in GVHD, the opposite happens: transplanted tissue unleashes a horde of T cells that spark a cascade of inflammation, within 100 days. Typically, GVHD follows a bone marrow

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