What do patients who go to stem cell clinics really think of their experiences? It can be hard to get good data on this important question. For that reason, it was great to see a new article on this topic. With perhaps around 2,000 unproven clinics in the U.S., these firms are likely to have […]
Some of you might remember the stem cell clinic firm R3 Stem Cell. I have major concerns about some of what they are marketing including in the U.S. I was reminded of R3 Stem Cell again just now. The Associated Press (AP) ran a PR on R3 Stem like it was a news story. I
Media like the AP promote unproven stem cell clinics such as R3 Stem Cell Read More »
FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I
Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »
What happens during brain aging and how can we tell if dementia is coming? Are there particular early hallmarks? There are an increasing number of medical tests for predicting or detecting dementia. Alzheimer’s disease can often be detected early. But what do patients or their doctors do with such information? Until recently there weren’t any
Weekly reads: brain aging, perinatal stem cell clinics, $1M lab meat fine bill Read More »
The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,
Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics Read More »
Those who follow the stem cell field might be familiar with stem cell clinic operator Neil Riordan. According to a recent press release and some news reports, Riordan just had some bad news in court related to a stem cell clinic in the U.S. Stem cell clinic lawsuit As background, why do those running stem
$7.8 million verdict in stem cell clinics case against Neil Riordan Read More »
The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a
New data on stem cell clinics, INDs, & more including from FDA itself Read More »
Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics
Even in COVID times the FDA continues its stepped-up efforts against stem cell clinics and patients are suing clinics more too, which I cover in today’s post along with recommended stem cell research pubs. One of the papers at the top of my to-read list is on 3D chromatin in stem cells. FDA Warning Letter
Weekly pubs & 2 stem cell clinics get bad news Read More »
It’s encouraging to see that the states including now Arkansas via their attorney generals (or is it attorneys general?) are taking more action against stem cell clinic firms, but the big scope of AG action has somewhat surprised me. Arkansas AG suit The latest AG action on a stem cell clinic type firm comes from
Arkansas adds to wave of state AG actions vs. stem cell clinics Read More »