Search Results for: exosomes

Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data

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Linda Marbán, Capricor

The cell therapy biotech Capricor recently released new data from their Duchenne Muscular Dystrophy (DMD) trial work. The data have generated excitement in the patient advocacy community. The stock has skyrocketed. How exciting are these new data? CEO Linda Marbán is quite upbeat and I think it’s justified. The firm is now seeking FDA approval […]

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

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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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New review of stem cell supplements and pills

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Stem cell supplements

Today’s post is a review and fact-check of stem cell supplements. This is the second time I have looked at the state of stem cell supplements. If anything, it seems things have gotten more complicated and problematic in the last two to three years. Supplements  |  Stem cell supplements claims | Supplement ads and products | Visiclear,

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Utah stem cell law OKs non-FDA approved placental cell drug therapies likely sparking conflict

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Utah Rep. Katy Hall

Utah appears ready to pass a new stem cell law that would explicitly allow clinical use of non-FDA-approved placental cell drug therapies in the state. Bill 199 seems likely to set up a conflict with the FDA that may land in court. The key part of the bill says: “A health care provider whose scope

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Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

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AXIOFILL, MiMedx

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter

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20 stem cell & regenerative medicine predictions for 2024

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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

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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

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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?

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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

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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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