Each year I make a list of predictions for the year to come for the stem cell and regenerative medicine field. Then about a year later I grade myself on how I did as that year winds down. Here’s how I did in 2016. For 2017, late in 2016 I made 20 stem cell predictions. Let’s […]
Grading my twenty 2017 stem cell predictions Read More »
How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results? I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing. In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their
Seattle clinic uses FDA commish in marketing non-FDA approved stem cells 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 »
I can see many reasons to be jolly on the regenerative medicine front as we get deeper into the holiday season as there is quite a lot of stem cell good news even if there is also some not so good news. In today’s post the focus is on the good news of late. Semma
Stem cell good news for the holidays: biotechs, FDA, organoids Read More »
By Hamideh Emrani (@HamidehEmrani) This year, Dr. Harold Atkins was honored with the Till & McCulloch Award. He and Dr. Mark Freedman led a clinical trial that used stem cells to reset the immune system as a treatment strategy for Multiple Sclerosis (MS) and a few other neurodegenerative diseases, such as stiff person syndrome. You can
According to The Bismarck Tribune and the AP/US News & World Report, the North Dakota Attorney General’s office is investigating a stem cell clinic in that state amid complaints. From the news articles: “The clinic has been offering stem cell injections for about a week and a half. Consumer Protection Division Director Parrell Grossman says there are
‘Very Alarmed’: North Dakota AG Investigating Stem Cell Clinic Read More »
Nominations have closed for the 2017 Stem Cell Person of the Year Award and we have a great group of nominees. I’ve listed them below in alphabetical order, along with a bit of description of who they are, which includes in some cases the language used by the nominator(s). Where possible I’ve included a link
20 Stem Cell Person of The Year 2017 Award Nominees Read More »
Now that in the past few months the FDA has issued stern statements (one this summer and more recently), both final and draft guidances, and at least one warning letter, what comes next? What will the clinics do if anything moving forward? What if anything will the FDA do in terms of actual concrete actions?
Polls: What will stem cell clinics & FDA do now? Read More »
In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to
Deconstructing FDA Mixed Bag Approach to Stem Cell Clinics Read More »
Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in
Fat stem cells are drugs: new FDA final guidances Read More »