Unproven stem cell clinics are facing a variety of lawsuits these days including two prominent cases filed by the FDA. There are widespread patient suits against clinics as well. In April we saw a new kind of suit in the form of the NY State Attorney General (AG) Letitia James filing against a Manhattan clinic. […]
NY stem cell clinic pushes back on lawsuit by AG Read More »
Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by
FDA needs to quickly act against IRBs enabling risky fat stem cell clinics Read More »
Japan is a leader in stem cell and regenerative medicine research, and in particular in clinical translation toward the bedside. Induced pluripotent stem cell (IPSC)-based investigational therapies are rightly an area of focus in Japan given their invention by Nobel Laureate Shinya Yamanaka. Small clinical studies based on IPSC have been initiated there for several
Japan stem cell clinical studies rapidly piling up Read More »
Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out
Scott Gottlieb leaving FDA: possible reasons, impact on stem cell field, & more 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.
There is real hope for treating spinal cord injury with stem cell-based therapies in the future. However, unfortunately regulators in Japan have taken a major misstep in approving a not-ready-for-primetime mesenchymal stem cell (MSC)-based approach to spinal cord injury. Their decision is dangerous and unwise. In a Nature piece (linked to above) by David Cyranoski
Japan’s dangerous gamble approving unproven stem cells for spinal cord injury Read More »
The Joint Commission apparently has given some kind of seal of approval to the unproven stem cell clinic-related firm, the Lung Institute, or as it is now often called the Lung Health Institute. For me this raises concerns about the Joint Commission itself or at least its ambulatory care accreditation program through which Lung Health
Red flag for Joint Commission for its gold seal approval to former stem cell clinic firm Read More »
What happens next to He Jiankui (贺建奎) or as some people now refer to him, the “CRISPR baby guy”? China has a challenging situation to resolve here, but such conflicts between scientists and governments have happened regularly in history. When scientists go “rogue” (i.e. don’t conform to norms or ethical standards in an extreme way or
For a long time at the end of each year, I’ve been making stem cell predictions for the coming year. Most often I’ve been making a “top 20” list of predictions and today’s post has my list for 2019. You can see how I did for 2018 here, which might have been my best year
20 stem cell & regenerative medicine predictions for 2019 Read More »
Each year I make a list of stem cell predictions for the following year and I’ll release my predictions for 2019 soon, but first I’m grading how my 20 predictions for 2018 turned out. It seems I did better than usual predicting what would happen this year. I only got a couple partial credit or
Good final grades on my 20 x 2018 stem cell predictions Read More »