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 »
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 »
As of October 1, Google was supposed to have banned ads for unproven stem cell clinics and products. This was according to their own new policy. How’s that going? How’s this new Google approach to unproven stem cell marketing working out in the real wild world of the web? To test it, I did over
My B grade to Google on early test of its stem cell clinic ad ban Read More »
Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a
FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates Read More »
Time to sell exosome therapies to patients? No. Some stem cell clinics and related firms are looking for new ways to make profits and toward that goal a few have latched onto the legitimate buzz around exosome research. What are exosomes? Imagine if you could bubble up a pea-sized sphere off your skin full of
As exosome work advances, clinics pitch unproven therapies to patients Read More »
By Claire Horner In 2016, a law firm in California began looking for individuals who were “misled or harmed by stem cell treatment” in the southern California area (which was discussed on this blog here). While there had been other lawsuits filed by plaintiffs against individual clinics, this firm was looking to take a different
The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning
FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem Read More »
When you think of Florida, what else crosses your mind first? Orange juice? Heat and humidity? Beaches? Disney? I don’t know if this says more about me or the state, but these days I think of stem cells. Florida and California are the two biggest hotbeds of the for-profit stem cell clinic world, each with
Sentinel Takes Investigational Deep Dive into Florida Stem Cell Clinic Soup Read More »
Stem cell clinic biotech Stemedica has just been sued by one of its own board members based on allegations related to money the company raised, according to CourtHouseNews. The actual suit, filed by an investment company Tiara Holdings and board member Anthony Marlon, can be read here. CourtHouseNews writes: “Tiara Holdings II LLC sued Stemedica Cell
Stemedica sued by board member over alleged mishandling of funds Read More »
This is the second in a series of videos I’m doing where I answer questions about the stem cell field. You can see the Episode 1 video here. Today I tackle more questions on the stem cell field. If you have more stem cell questions, let me know and I’ll try to answer them next time.
Q&A video with Paul Episode 2: stem cell & CRISPR questions answered Read More »