Kimera Labs

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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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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Review of where Kimera Labs fits into sphere of exosome companies

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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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Historic spring storm of FDA letters to stem cell clinic industry

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

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cell therapy for COVID

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

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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?

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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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