At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it […]
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »
If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a
40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke Read More »
The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the
Clinic biz US Stem Cell reports SEC subpoena, adding to uncertainty on its future Read More »
Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months
Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women Read More »
FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some
Take-homes from new FDA NEJM stem cell piece including surprises Read More »
Every year I look into my stem cell crystal ball and make predictions for our field including regenerative medicine. Well, I don’t really look into a crystal ball, but I try to use a combination of what I’m hearing through the grapevine, stuff I’m reading, some info that is not yet in the public domain,
20 predictions for stem cells & regenerative medicine in 2018 Read More »
Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting
Mesoblast gets FDA RMAT; List of 10 total designations so far Read More »
In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to
Deconstructing FDA Mixed Bag Approach to Stem Cell Clinics Read More »
Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The
New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »
Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do
Dissecting the FDA’s big, fat stem cell dilemma Read More »