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 […]
Kimera Labs FDA letter cites exosomes for COVID-19, more issues Read More »
The California Stem Cell Agency, better known by the acronym CIRM, has done a vast amount of good over the past decade and a half, and today it needs your help for the future. CIRM, which stands for the “California Institute for Regenerative Medicine”, has funded a huge array of stem cell and other research
Please take a couple minutes now to help fund future of CIRM Read More »
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
‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter Read More »
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
FDA needs to act boldly on unproven exosome therapies Read More »
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
Liveyon is back (again) with unproven exosome product Read More »
The novel coronavirus and the disease it causes, COVID-19, have swept the world with few proven treatment options. Vaccines are only recently being rolled out the last 2 or so months, which gives some real hope. While the novel coronavirus-caused illness is generally a mild disease in kids (many of whom don’t even show symptoms),
The Niche COVID-19 updates & resources Read More »
It’s notable how the FDA now considers gene-editing a kind of regenerative medicine. This means that various gene therapy products in development technically qualify as regenerative therapies. Ever since the agency began its rapidly growing regenerative medicine advanced therapy (RMAT) designation program, we’ve seen an increasing number of gene therapy biotechs and products qualify as
Regenerative medicine recommended reads including $191 million to researcher Read More »
Retraction Watch broke the news that Haruko Obokata of the STAP cell train wreck now has a 4th paper retraction. The publication related to the controversial idea that adult tissues have pluripotent potential or actual pluripotent stem cells in them so it was kind of foundational for the debunked STAP cell idea. It also reminds
4th Obokata retraction after Harvard investigation: STAP saga finally over? Read More »
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
More Liveyon links to exosome Awakening film include potential relative Read More »
Making a CRISPR baby is a controversial idea to even propose now for many reasons, yet even after He Jiankui’s train wreck some people have seemed eager to try it including apparently a scientist whose name perhaps many readers here are not so familiar with in this context: Professor Hui Yang. ‘CRISPR baby guys’ Is
Heads up on Hui Yang, another potential aspiring CRISPR baby researcher Read More »