July 12, 2020

The Niche

Knoepfler lab stem cell blog

exosomes covid-19

5 min read

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 lead-up to wave of FDA activity I count 7 letters in a less than two-month span from mid-March to now, which may be the most in history in the …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

2 min read

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 morning about stem cells combating the novel coronavirus (HT to @Bryson_M). Today we discuss the use of stem cell therapy to combat the novel coronavirus #COVID19 Americans are organizing …Read More