January 27, 2021

The Niche

Trusted stem cell blog & resources

exosomes

5 min read

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 medicine arena. I’ve linked to each announcement below with the agency’s title of the announcements. Underneath I provide some analysis and ask questions. I’ve also included some other stem …Read More

3 min read

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 sparked it? My sense is that a major trigger was Kimera Labs being linked some weeks back to an experimental infusion of exosomes into a COVID19 patient. The letter …Read More

7 min read

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 during his tenure I interviewed him here on The Niche about the challenges and future of the stem cell/regenerative medicine field. You can read more about the Morrison lab …Read More

3 min read

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 letter went out to Invitrx mentioning almost as an aside an unapproved exosome product amongst many other products and issues. No, I don’t have some secret red telephone where I …Read More

3 min read

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 have been hurt in Nebraska by some product involving exosomes. There is legit, exciting exosome research ongoing all over now. I believe these little cellular bubbles full of different …Read More

3 min read

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 some of the product was somehow contaminated with bacteria along the way before injection in patients. There was a recall, an FDA warning letter, lawsuits, and a voluntary suspension …Read More

4 min read

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 video) recently denied involvement in an email exchange with me. Awakening drew so much attention in part because of its strong sci-fi vibe and its implication that the exosome …Read More

4 min read

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 kind of sci-fi miracle med? I hope so! For more on exosomes and legit research into them see this past guest post. Note that allogeneic exosomes used clinically appear …Read More

5 min read

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 for perinatal stem cell clinic and exosome suppliers. For general background on exosomes see these past The Niche posts. I’m sure there are a lot of hardworking folks at …Read More

2 min read

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 the Icahn School of Medicine at Mt. Sinai, a new PNAS pub, “Multipotent fetal-derived Cdx2 cells from placenta regenerate the heart.” Congrats to first author Sangeetha Vadakke-MadathilThis is a …Read More