If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
A clinic called DVC Stem selling unproven stem cells has popped up prominently on the web recently. It’s a relatively new and in some ways puzzlingly dominant presence on the stem cell section of the Internet. We should pay attention to these kinds of changes on the web. They can impact many people’s healthcare choices, …
Review of DVC Stem & marketing of unproven therapies Read More »
There are so many stem cell clinics out there that it can be hard to keep track of them and the news about them, but a big court victory against a Manhattan stem cell clinic by New York State Attorney General Letitia James is notable for several reasons. Injunction on Park Avenue Stem Cell clinic …
New York wins $5.1 million in suit against Manhattan stem cell clinic Read More »
If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with …
Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs Read More »
A firm called Utah Cord Bank has been in the news related to stem cell clinics over the past year or two. Now they have received an FDA Warning Letter for a variety of manufacturing issues. Utah Cord Bank Background In terms of some brief backstory, Utah Cord Bank first popped up on my radar …
FDA warning to stem cell clinic supplier Utah Cord Bank Read More »
I remember seeing a cowboy-type TV show when I was a little kid where a guy pulled into town not slinging guns but selling snake oil. He stood right up on his wagon and started pitching the wonders of what he was selling. He had some buyers pretty quick. Eventually, someone like a sheriff or …
Snake oil history from century old elixirs to fake stem cells Read More »
Those of you following the arena of unproven stem cells might recognize the name Dr. Joseph Mercola. He’s a promoter of alternative medicine. Over the years his name has also popped related to the marketing of unproven stem cell offerings in various ways. Now the FDA has warned Joseph Mercola on what it says are unapproved …
What should we make of clinics like the Lung Health Institute? These clinics sell unproven stem cell or regenerative therapies for lung disease. Overall, I’m extremely skeptical. I don’t believe it’s worth the cost. There are also going to be potentially serious health risks. Lung disease is a broad category including COPD, emphysema, pulmonary fibrosis, …
Fact check: Lung Health Institute & cell therapies for lung disease Read More »
Recently I was going through a list I’m updating of regenerative medicine biotech companies including Bluebird bio. Now just a few days later the world seems turned upside down for the firm and maybe to some degree for other companies doing related work. Bluebird bio blues: 2 trial participants get cancer News broke today that …
Bluebird bio sickle cell gene therapy trial halted on cancer worry Read More »
This week we have some interesting new reading including both on the stem cell basic and translational fronts as well as on COVID-19 vaccines. COVID-19 vaccine considerations From Derek Lowe at In The Pipeline on COVID-19 vaccine expectations at Science Translational Medicine, Get Ready for False Side Effects. You can read my views on possible …
Recommended stem cell reads: retractions, aging, COVID, CRISPR soldiers Read More »