Search Results for: kimera labs

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

January 21, 2024 / By / 10 Comments
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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Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit

September 30, 2023 / By / 10 Comments
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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Where Kimera Labs fits into sphere of exosome companies

March 16, 2023 / By / 4 Comments
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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Kimera Labs FDA letter cites exosomes for COVID-19, more issues

February 10, 2022 / By / 8 Comments
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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20 stem cell & regenerative medicine predictions for 2024

January 10, 2024 / By / 4 Comments
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

December 27, 2023 / By / 1 Comment
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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2023 stem cell & regenerative medicine predictions

December 28, 2022 / By / 1 Comment
stem cell predictions

Toward the end of each year, I make stem cell & regenerative medicine predictions for the coming year. It’s a fun tradition here on The Niche that goes way back. The stem cell field has changed dramatically as reflected in each year’s predictions. Here’s a list of past predictions with my grades of how they …

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Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT

February 1, 2021 / By / 7 Comments
EUCYT-CEO-Travis-Bird

The FDA dropped a lengthy, extremely critical warning letter on a supplier of unproven exosome product called EUCYT Laboratories. For broader context, exosome therapy has somehow burst onto the scene when there’s no good data yet in my view to back up its use in the clinic. The FDA is taking notice with letters already sent …

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Historic spring storm of FDA letters to stem cell clinic industry

February 1, 2021 / By / 7 Comments
FDA-letter-stem-cells

The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on …

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