Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance […]
FDA outlines potential crackdown on Clinicaltrials.gov offenders Read More »
What do you read on the weekend? I wish for me it was at least in part some contemporary novel or science fiction, but that’s rare. More often than not it is almost all science. I do read the Sunday NY Times at least. I usually accumulate things during the week that I want to
TGIF Weekend Science Reads: stem cells, PRP, CIRM, CRISPR, & more Read More »
Last year I started seeing stem cells mentioned along with the opioid crisis in a particular way, but now recently I saw an entirely different pairing of stem cells with the opioid crisis. The first connection I saw was of a few for-profit, unproven clinic firms claiming that for pain sufferers it would be better
The opioid crisis, pain, stem cells, & FDA Read More »
Every year in December I go out onto a limb and make stem cell predictions for the coming year as I did in late 2017 for this year. Then usually around the 1/2-way point through the year I check in on how the predictions are faring so far at that point. In this post I give
Midterm grades on my 20 x 2018 stem cell predictions Read More »
Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits?
When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon? Read More »
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 »
The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point
In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms 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 »