Search Results for: compassionate use

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

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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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Overselling stem cells for COVID-19: WSJ article & UMN PR

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Many are  jumping on the bandwagon of trying stem cells for COVID-19 or testing other cellular therapies for the novel coronavirus disease, but there have been problems with either the rationales for the trials themselves or more often with how they portrayed. Sometimes there has even been outright hype. I’ve called this collective trend of …

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New Mesoblast “COVID kid” stem cell study

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The biotech Mesoblast is starting an expanded access study of its stem cell product for kids with a severe offshoot of COVID-19. The cellular drug in this case is remestemcel-L (more below). While most children fare better than adults in dealing with COVID-19, the rare subset of kids with COVID-19 for this study have more severe …

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COVID-19 cellular medicine buzz: Mesoblast, FTC hammer, more

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  It’s been a busy week for the cellular and regenerative medicine space for COVID-19 news with some possible ups including for Mesoblast and some definite downs. Starting with the more positive media buzz with have Mesoblast. Mesoblast made COVID19 news “Thinly traded Mesoblast Limited (NASDAQ:MESO) rockets 51% premarket on average volume in reaction to its announcement of an …

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As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes?

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When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow. Unfortunately, there are reasons to be increasingly concerned here. For instance, …

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Right To Try law has a big loophole that’s an opening for bad actors

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There appears to be a big, risky loophole in the relatively new national Right To Try law. Some folks apparently anticipated this problem long ago, but I think most of us weren’t aware of it. Update: More specifically, some law and policy experts were writing about this and other potential loopholes in 2018. I recommend …

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Probing F1 legend Michael Schumacher stem cell juice story

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What’s the deal with Michael Schumacher and his Hail Mary stem cell procedure. Usually when we hear about celebrities getting unproven stem cells, it’s the celebrity themselves or their PR machine hyping it in exchange for something like free treatments or even money from those offering the stem cells for sale, but in the past …

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Richard Garr Q&A on his new Right-To-Try firm Beacon of Hope

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A new right-to-try company called Beacon of Hope is stirring some intense discussion. State and federal right-to-try laws could potentially change the fabric of how many investigational studies are conducted. That may happen through firms like Beacon of Hope. However, we don’t know much about the firm. I’m hoping to help change that. Today’s post …

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Stem cell clinic experimenting on patients with unapproved genetically modified ‘cancer vaccine’?

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What if it seemed based on the public statements of its leader that a business was using an unapproved and unproven, genetically-modified, stem cell-based ‘cancer vaccine’ on patients? Is that possible? Sometimes I think I’ve seen and heard it all when it comes to companies marketing non-FDA approved, scientifically unproven stem cell ‘therapies’ to patients …

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Popping the bubble of stem cell populism

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What happens if we mix stem cells with populism? From a populist view of stem cells, everyday patients should be able to do nearly anything they want with stem cells without any governmental interference or excessive expense. Even stem cells not proven to be safe or effective. This can sound like an appealing idea to …

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