Search Results for: exosomes

20 stem cell & regenerative medicine predictions for 2024

Stem cell, crystal ball, predictions

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

stem cell predictions

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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Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit

Symptoms_of_multiple_sclerosis

There has been a steady stream of encouraging data on stem cells for MS. Particularly for certain kinds of MS. A new study adds to this upbeat direction. Good news on stem cells for MS Haematopoietic stem cell transplantation for treatment of relapsing-remitting multiple sclerosis in Sweden: an observational cohort study, Journal of Neurology, Neurosurgery, …

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Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

Burst Biologics, Christopher Jones

The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The …

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Update on stem cells & cell therapy for COVID trials

cell therapy for COVID

From the beginning of the pandemic, I have been mostly skeptical about the idea of cell therapy for COVID including stem cell therapies. However, at the same time, I’ve closely followed the data, especially up until 2022. Now having just had a nasty bout with COVID myself for the first time this summer, I recently …

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Where Kimera Labs fits into sphere of exosome companies

Kimera labs exosome

Today’s post takes a close look at the exosome manufacturer Kimera Labs in the context of the main exosome companies. What are exosomes? Exosomes are microscopic bubbles or vesicles produced by cells. Exosomes contain many cellular substances that are biologically active. Some of these materials may be helpful clinically, while others could pose risks. Clinical outcomes …

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WHYY oh WHYY: NPR puff piece on risky stem cell microneedling

I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling.  Is this journalism or product promotion? The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How …

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Weekly reads: human CRISPR, MRT risks, private IRBs, skincare

David Liu, human CRISPR

It’s funny how sometimes there are many new articles about one general topic like this week with heritable (and somatic) human CRISPR gene editing and related tech.  There are clear reasons for optimism in the somatic arena given advancing trials. Germline editing remains highly questionable in my view even just technically. Then there are loads …

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Does Medicare cover stem cell therapy? Mostly no & it’s poised to recoup tens of millions

Regenative labs, does Medicare cover stem cell therapy?

Does Medicare cover stem cell therapy? Readers of The Niche have regularly asked this question. They’re curious about insurance coverage too. The answer is “no” in almost every case, with some notable exceptions I’ll get to at the end of the post. Still, clinics appear to have already been charging Medicare for what collectively adds …

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3rd Invitrx warning highlights FDA oversight weakness

The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past …

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