The term Regenerative Medicine covers so much biomedical science these days including everything from just about any kind of cell therapy (not just stem cells) to CRISPR gene editing, and with the the COVID-19 pandemic, it seems this umbrella use of the term now includes potential treatment of viral illnesses. It can be hard to […]
Update on stem cells for COVID-19, Surgisphere scandal Read More »
In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a
Last year around this time I took my annual plunge to make 20 predictions for the coming year for the stem cell and regenerative medicine field. I even made a crystal ball graphic to highlight the complexity of the stem cell ecosystem into which these predictions were embedded (see image) for 2019. How’d I do?
B+ on my report card on my 20 stem cell predictions for 2019 Read More »
The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest
Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game? Read More »
Every so often I realize I’ve accumulated a bunch of tabs on my browsers of things I need to dive into as time permits, which sometimes translates into a collection of recommended reads here on The Niche. Here are some recommended recent reads in the stem cell/regenerative medicine field and childhood cancer space. It includes
Weekend reads: stem cells, CRISPR, glioma, stroke, RTT & more 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 we mix celebrities like William Shatner who played Captain Kirk on the original Star Trek series with stem cells, things usually end badly. For this reason when I read that Shatner had gotten a supposed stem cell treatment, I saw it as bad news. Like the arrival of a Borg ship. Just one problem
About that Captain Kirk ‘stem cell treatment’ Read More »
Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a
FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates Read More »
In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further,
Clinic biz US Stem (USRM) may be kaput in matter of weeks or months Read More »
When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman.