Search Results for: exosomes

Answering reader questions: snorting stem cells, Regenexx, exosomes

Brain-PET-scan, stem cells

One of the most interesting parts of running The Niche is that I get all these questions about stem cells and related matters from readers. I try to answer questions regularly by email, but sometimes the volume catches up with me. For that reason I periodically try to do posts answering such questions, which has […]

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Kimera Labs FDA letter cites exosomes for COVID-19, more issues

Duncan-Ross

A firm called Kimera labs just received an untitled letter from the FDA. The firm has been supplying non-FDA-approved exosomes to various customers including at least one stem cell clinic without sparking any obvious action from the agency, but on April 10th that changed with the letter, which in my view is quite serious. What

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

Kimera-Labs-exosomes-COVID-19-novel-coronavirus-disease

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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Mystery of wild sci-fi film ad for unproven exosomes: Liveyon?

awakening-exosome-film-ad

What’s Liveyon up to these days? A new, somewhat mysterious short film that serves as an advertisement for unproven exosomes has some of us scratching our heads. It seems to point to Liveyon. Can you guys as readers of The Niche help solve the puzzle of who’s behind this wild “cinematic commercial” and what the

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Why did Texas A&M ink big deal with stem cell clinic firm Celltex on exosomes?

Texas-AM-Celltex-deal

The recent news that Texas A&M University has inked a full-blown deal with the direct-to-consumer stem cell clinic firm Celltex struck me as an unusual development. Recently we’ve seen more universities exploring the use of stem cells outside of the traditional FDA clinical trial process that is fundamentally based on an investigational new drug application (IND). Some

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Review of Nature paper: stem cell exosomes on the brain and aging

mouse-hypothalamus-brain-and-aging

Is there a stem cell connection between the brain and aging? Could a type of brain stem cell or the exosomes it secretes control whole body aging? A recent big Nature article from the lab of Dongcheng Cai argues an emphatic “Yes” to these questions, at least in mice. In the Zhang, et al paper, entitled

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What are exosomes and can they be used for therapy?

Mesenchymal-stem-cell-exosomes

What are stem cell exosomes? There’s been an explosion of interest in the biomedical world around a recently characterized cell-to-cell communication system that most cells use to talk to one another, including stem cells. In fact the first patient has been successfully treated in Germany with exosomes derived from mesenchymal stem cells for refractory graft

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FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,

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