Search Results for: perinatal fda

Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees

July 9, 2022 / By / 1 Comment
Human-cloning

Cloning is one of those topics that both fascinates and kind of scares people, especially the idea of duplicating people. I regularly cover the topic here on The Niche because stem cell technologies are involved. Also, one form of the process sometimes called “therapeutic cloning” involves embryonic stem cells. Duplicating mammals has now long been …

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Weekly reads: NIH grants, side effect of darker hair, FDA warning, CRISPR

July 2, 2022 / By / Leave a Comment
Grant writers handbook, grants cartoon

The last six months I’ve been spending even more time than usual writing NIH grants (and a few others). The last two weeks have been especially busy on this front as I am getting an R01 renewal out the door. My paper reading lately has been mostly related to the grant writing I’m doing. Still, …

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Why did clinic supplier Liveyon halt sales but others kept going despite FDA?

June 6, 2022 / By / 1 Comment
Liveyon-reincarnated

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in …

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FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms

September 26, 2023 / By / 13 Comments
Roya-Panah-Kosolcharoen

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day …

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Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

February 1, 2021 / By / 10 Comments
FDA-untitled-letter

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest …

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Bad Batch podcast’s dark picture of perinatal stem cell industry

March 2, 2022 / By / 4 Comments
John-Kosolcharoen-Liveyon-Bad-Batch

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have …

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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

October 26, 2021 / By / 25 Comments
R3-Stem-Cell-testimonials

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a …

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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

February 1, 2021 / By / 1 Comment
umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the …

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Man could get 240 yrs for amniotic fluid for knees Medicare scam

February 6, 2024 / By / 3 Comments

A Justice Department press release details how a physician’s assistant (PA) in Texas was convinced of fraud related to amniotic fluid injections. This story tells us some important things about how Medicare handles things versus the FDA approach to such things. Amniotic fluid scam A jury found Ray Anthony Shoulders, a PA at a pain …

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