exosomes covid-19

Historic spring storm of FDA letters to stem cell clinic industry

FDA-letter-stem-cells

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 …

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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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Rudy Giuliani now plugging unproven stem cells for COVID19: is Trump next?

Rudy-Giuliani-stem-cells-COVID19

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 …

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As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes?

Kimera-Labs-exosomes-COVID-19-novel-coronavirus-disease

When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow. Unfortunately, there are reasons to be increasingly concerned here. For instance, …

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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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