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 …
Historic spring storm of FDA letters to stem cell clinic industry Read More »
The Niche has had many authors over the years, focusing on expertise in the biomedical arena and in particular related to stem cells. I’ve invited many authorities in particular areas to write posts. Over the years I’ve written probably 99+% of the posts here on The Niche, but we’ve also had some great guest authors …
The idea of testing stem cells for COVID-19 may be music to the ears of some folks as an opportunity, but to me from the beginning it sounded mostly like a spaghetti on the wall road to trouble. There is buzz out there that some kind of stem cells or other cells will help with …
Field throws stem cells for COVID-19 like spaghetti on the wall Read More »
How can we scientists find ways to keep doing our research during the COVID19 pandemic even if it has nothing to do with the coronavirus? Also, how should those of us involved in science communication talk about the outbreak? At a more basic level, how can scientists try not to go bonkers during this dark …
Scientists try not to lose it with their labs shut by the pandemic Read More »
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 …
COVID-19 cellular medicine buzz: Mesoblast, FTC hammer, more Read More »
Could various kinds of cell therapy help patients with COVID-19? A variety of cell therapies, mostly focused on mesenchymal stromal/stem cells (MSCs), have gotten cleared quickly in the U.S., China, and Israel and possibly other countries to be tested in patients with the novel coronavirus. I hope at least one proves helpful. It’s mostly a …
Cell therapy trials for COVID-19 accelerate & some early reports Read More »
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 …
Interview with Sean Morrison on cellular therapies for COVID-19 Read More »
Things are getting worse with the COVID19 pandemic and in parallel there is increasing hype including from clinics that somehow stem cells or similar products could help with the latest (and most worrisome) development being a bombshell tweet from Trump’s lawyer Rudy Giuliani. The former mayor of New York and Trump frontman just tweeted this …
Rudy Giuliani now plugging unproven stem cells for COVID19: is Trump next? 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 »