Utah appears ready to pass a new stem cell law that would explicitly allow clinical use of non-FDA-approved placental cell drug therapies in the state. Bill 199 seems likely to set up a conflict with the FDA that may land in court. The key part of the bill says: “A health care provider whose scope …
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 »
When a vendor of important reagents like antibody supplier Abcam charges big money, those high Abcam prices could negatively impact research in the long run. Some of the prices are so high that buying just a few antibodies could take up a small but meaningful slice of an entire R01 grant. Sky-high Abcam prices I’ve …
Weekly reads: abundant Abcam prices, speedy aging & cancer, stemmy CAR-T, more on STAP Read More »
What is immune rejuvenation? How would that work and what would be the benefits? As we age, our immune systems can change in unhelpful and unhealthy ways. One such change is a drift in the balance of production of different kinds of immune cells. Such a shift can lead to too many of some immune …
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 …