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 »
After almost a decade blogging about stem cells from just about every angle, it’s interesting to consider trends in the types of questions I get asked such as this much more common one now as compared to 2010: How much is stem cell therapy? What does a patient pay on average for stem cells in …
How much is stem cell therapy? 2019 cost poll results 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 »
We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters. …
Muddy waters: stem cell clinic calls itself CIRM & docuseries sparks controversy Read More »
It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently). …
Reactions to historic stem cell clinic court loss, new court order, & what happens next? Read More »
In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is …
Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court 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 »
The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow …
Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry Read More »
Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the …
Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters Read More »