We’ve known that most organs have resident stem cell populations for decades, but things have been less clear in the lung and it has only been relatively recently that lung stem cells have been definitively characterized. Why is so important? Lung stem cells, whether endogenous or made in the lab, have the potential to help […]
Recommended reads: lung stem cells, Utah stem cell law, Ozzy gets cells Read More »
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 »
The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA. If SCOTUS takes the case, the FDA could find its powers
FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in Read More »
Toward the end of each year I make predictions for the stem cell and regenerative medicine field for the coming year. I’ve been doing this for more than a dozen years in various forms. In this post I’m looking at the (gene-edited, stemness enriched) tea leaves for 2025 for the regenerative arena. These predictions include
25 stem cell & regenerative medicine predictions for 2025 Read More »
Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely. They are not scientifically or medically proven to work or be safe so they could lead to substantial harm. This is yet another early step in a likely growing trend of states challenging FDA authority
I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah
Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society Read More »
I was interested to see that an organization called The Perinatal Stem Cell Society seems to have been upbeat about the new Utah stem cell law. That law sets up a likely conflict with the FDA and federal law over stem cells. In a nutshell, Utah now says you can sell non-FDA-approved stem cells in
Q&A with Kyle Cetrulo of The Perinatal Stem Cell Society on the FDA, state laws, & more 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 »