exosomes

Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy

Levy-et-al-MSCs-Science-Advances

Ready for the latest recommended weekly reads in the world of stem cells and the regenerative medicine space including a bunch of important new FDA posts & changes? This post has quite a lot on the FDA since it had a very big week with several new items of major importance to the cellular and regenerative …

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

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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Interview with Sean Morrison on cellular therapies for COVID-19

Sean-Morrison

To get at addressing what’s the real deal on the idea of cellular therapies for COVID-19, I did a short email Q&A interview with Dr. Sean Morrison. Sean is Chair of the Public Policy Committee at ISSCR and Director of Children’s Research Institute at UT Southwestern. He was also President of ISSCR in 2015-2016, and …

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‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter

Habib-Torfi

Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning …

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FDA needs to act boldly on unproven exosome therapies

exosomes-visualized-by-EM

The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people …

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Liveyon is back (again) with unproven exosome product

Liveyon-Luma

Remember our old friends Liveyon? Their leader John Kosolcharoen? Liveyon’s continuing metamorphosis This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. That stem cell thrust ultimately landed a dozen or more people in the hospital as …

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More Liveyon links to far-out exosome Awakening film include potential relative

Awakening-film-marketing-screenshot

A new film-commercial entitled Awakening pitches unproven exosomes and has already been possibly tied to the troubled stem cell supplier firm Liveyon, but now it seems that the links go far deeper including a possible relative of Liveyon leader John Kosolcharoen. Even so, Kosolcharoen (pictured with another Liveyon leader Alan Gaveck below in a web …

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Help solve mystery of wild sci-fi film ad for unproven exosomes

awakening-exosome-film-ad

A new, somewhat mysterious short film that serves as an advertisement for unproven exosomes has some of us scratching our heads. Can you guys as readers of The Niche help solve the puzzle of who’s behind this wild “cinematic commercial” and what the deal is with the unproven exosome product it seemingly promotes as some …

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

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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Stem cell good news & pubs in late May 2019

Sangeetha-Vadakke-Madathil-et-al.-screenshot-of-video-PNAS-2019

The exciting and sometimes downright crazy giant stem cell ecosystem of legit research and unproven stem cell clinics could use a dose of good news now and then. In today post, I highlight some upbeat news and some interesting recent pubs. Enjoy! From a team led by Hina Chaudhry, MD, Director of Cardiovascular Regenerative Medicine at …

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