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 »
Up until now Utah hasn’t immediately come to mind as a hub for stem cell issues, but things are heating up there in 2019. Utah? I was going to do a blog post here on The Niche last month about perinatal (birth-related) biologics and stem cell-related supply companies in Utah. Some of their customers appear …
‘Bottom of stem cell barrel’? Utah piece sparks legal threat Read More »
In today’s post, I reviewed a stem cell clinic firm called Docere Clinics. In my opinion, there are some concerning issues here and reasons for caution. One type of procedure at Docere is particularly surprising and raises risks in my view. What is Docere Clinics? | What kind of stem cells does Docere use? | What they …
Review of Docere Clinics run by Harry Adelson including total-body injections Read More »
Early in the pandemic I was looking for something to do outdoors that was fun and new, finally settling on birding. Why? I have been interested in nature and photography since I was a kid but only occasionally had the chance to actually combine the two. Inspired in part by my colleague Jonathan Eisen here …
Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …
What is an FDA warning letter & how should firms respond Read More »
I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is …
Fact-checking troubling R3 Stem Cell clinic chain Read More »
The news just keeps getting worse for Missouri state lawmaker Patricia Derges, who was indicted last year by the feds for an alleged stem cell scheme. She is now also being sued by a former patient. Derges, who is not a physician but rather an assistant physician, was providing supposed stem cell or related biological …
Today’s post lists the best stem cell blogs and more generally the top biology blogs as well as websites. Making lists of “the best” of anything is fun yet it can be tricky. However, I feel that it can also serve a purpose as a resource. You might also enjoy these other “top” lists I’ve …
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
The world of stem cell research and regenerative medicine is unpredictable but it’s fun to be a part of it and try to do predictions. Each year in late December or early January I make prognostications for the coming year for stem cell research and regenerative medicine. I made 21 such predictions for the current …
Grading my 21 stem cell & regenerative medicine predictions for 2021 Read More »